€¦ · RTF file · 2007-04-10Marketing Exclusivity GenStar Therapeutics Corporation 10835 Altman Row Suite 150 San Diego CA 92121 ***** Generic Name Approved Orphan Indication:

Cumulative List of All Orphan Designated Products

Total Number of Active Designations 1697Effective:2/26/2007

Generic NameApproved Orphan Indication:

Treatment of anthrax infection per TNguyen 2/13/06 jb.

Trade Name:

ValortimOrphan Designation:

Treatment of anthrax infection

Designation

2/16/2006Sponsor and Address

Marketing Exclusivity PharmAthene, Inc.

175 Admiral Cochrane Drive

Suite 101

Annapolis MD 21401

***************************************************************************************


Trade Name:

Orphan Designation:

Treatment of Chronic Functional Vomiting to include functional

vomiting and cyclic vomiting syndrome.

Designation


Marketing Exclusivity Dynogen Pharmaceuticals, Inc.

52 Second Avenue

Waltham MA 02451

***************************************************************************************


Trade Name:

MarqiboOrphan Designation:

Treatment of acute lymphoblastic leukemia.

Designation


Marketing Exclusivity Hana Biosciences, Inc.

7000 Shoreline Court

South San Francisco CA 94080

***************************************************************************************


Trade Name:

AnthimOrphan Designation:

Treatment of exposure to B. anthracis spores

Designation


Marketing Exclusivity Elusys Therapeutics, Inc.

25 Riverside Drive

CA

***************************************************************************************


(+/-)-7-[3-(4-acetyl-3-methoxy-2-

propylphenoxy)propoxy]-3,4-dihydro-8-propyl-2H-1-

Trade Name:

Orphan Designation:

Prevention of serious adverse events associated with vascular leak

syndrome caused by Interleukin-2 therapy

Designation


Marketing Exclusivity Intarcia Therapeutics, Inc.

2000 Powell Street

Suite 1640

Emeryville CA 94608

***************************************************************************************


(1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-

methoxy-alpha-(1-naphthyl)-beta-phenyl-3-

quinolineethanol

Trade Name:

Orphan Designation:

Treatment of pulmonary tuberculosis (active disease)

Designation


Marketing Exclusivity Tibotec, Inc.

1020 Stony Hill Road

Yardley PA 19067

***************************************************************************************


(1S)-1-(9-deazahypoxanthin-9-yl)-1,4-dideoxy-1,4-

imino-D-ribitol-hydrochloride

Trade Name:

Orphan Designation:

Treatment of chronic lymphocytic leukemia and related leukemias to

include prolymphocytic leukemia, adult T-cell leukemia, and hairy

Designation cell leukemia


Marketing Exclusivity BioCryst Pharmaceuticals, Inc.

2190 Parkway Lake Drive

Birmingham AL 35244

***************************************************************************************




Trade Name:

Orphan Designation:

Treatment of acute lymphoblastic leukemia

Designation




Birmingham AL 35244

***************************************************************************************




Trade Name:

Orphan Designation:

Treatment of T-cell non-Hodgkin's lymphoma

Designation




Birmingham AL 35244

***************************************************************************************


(2Z)-2-cyano-3-3hydroxy-N-[4-(trifluoromethly)phenyl]-

2-hepten-6-ynamide

Trade Name:

FK778Orphan Designation:

Prevention of acute rejection following kidney, heart, and liver

tranplantation

Designation


Marketing Exclusivity Fujisawa Healthcare, Inc.

Three Parkway North

Deerfield IL 60015-2548

***************************************************************************************


(3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazole-3-yl]-benzoic

acid

Trade Name:

Orphan Designation:

For use in the treatment of cystic fibrosis resulting fron a nonsense

(premature stopcodon) mutation in the cystic bibrosis transmembrane

Designation conductance regulatory gene.


Marketing Exclusivity PTC Therapeutics

100 Corporate Court

South Plainfield NJ 07080

***************************************************************************************


(3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazole-3-yl]-benzoic

acid)

Trade Name:

Orphan Designation:

Treatment of Muscular Dystrophy resulting from premature stop

mutations in the dystrohin gene.

Designation


Marketing Exclusivity PTC Therapeutics, Inc.

100 Corporate Court

South Plainfield NJ 07080

***************************************************************************************


(3S)-3-[(2S)-2-({N-[2-tert-

butyl)phenyl]carbamoyl}carbonylamino)

propanoylamino]-4-oxo-5-(2,3,5,6-

Trade Name:

Orphan Designation:

Treatment of patients undergoing solid organ transplantation.

Designation


Marketing Exclusivity Pfizer Global Research and Development

50 Pequot Avenue

New London CT 06320

***************************************************************************************


(4S)-4-ethyl-4-hydroxy-3,14-dioxo-3,4,12,14-

tetrahydro-1-H-pyrano[3?,4?:6,7]-indolizino-[1,2-b]-

quinoline-11-carbaldehyde O-(tert-butyl)-(E)-oxime

Trade Name:

GimatecanOrphan Designation:

Treatment malignant glioma

Designation


Marketing Exclusivity Novartis Pharmaceuticals Corporation

One Health Plaza

Building 105

East Hanover NJ 07936-1080

***************************************************************************************


(6R,S)5,10-methylene-tetrahydrofolic acid

Trade Name:

CoFactorOrphan Designation:

For use in combination with 5-fluorouracil for the treatment of

patients with pancreatic cancer

Designation


Marketing Exclusivity Adventrx Pharmaceuticals, Inc.

6725 Mesa Ridge Road

Suite 100

San Diego CA 92121

***************************************************************************************


(9-[N-(3-morpholinopropyl)-sulfonyl]-5,6-dihydro-5-

oxo-11-H-indeno [1,2-c] isoquinoline

Trade Name:

Orphan Designation:

Prevention of post-operative complications of aortic anuerysm

surgical repair

Designation


Marketing Exclusivity Inotek Pharmaceuticals Corporation

100 Cummings Center

Beverly MA 01915

***************************************************************************************


(R)-N-[2-(6-chloro-5-methoxy-1H-indol-3-

yl)propyl]acetamide

Trade Name:

Orphan Designation:

Treatment of circadian rhythm sleep disorders in blind people with no

light perception

Designation


Marketing Exclusivity Phase 2 Discovery, Inc.

3130 Highland Avenue, Third Floor

Cincinnati OH 45219-2374

***************************************************************************************


(R)-N-[2-(6-Chloro-methoxy-1H-indol-

3yl)propyl]acetamide

Trade Name:

Orphan Designation:

Treatment of neuroleptic-induced tardive dyskinesia in schizophrenia

patients

Designation


Marketing Exclusivity Phase 2 Discovery, Inc.

3130 Highland Ave.

Third Floor

Cincinnati OH 45219

***************************************************************************************


(UDU-stereoisomer of c-UJUun UNU-terminal

UkUnhibitor)

Trade Name:

Orphan Designation:

Treatment of acute sensorineural hearing loss

Designation


Marketing Exclusivity Auris Medical, Inc.

211 East Ontario Street

Chicago IL 60611

***************************************************************************************


[5,10,15,20-tetrakis(1,3-diethylimidazolium-2-

yl)porphyrinato] manganese(III)pentachloride

Trade Name:

Orphan Designation:

Treatment of Amyotrophic Lateral Sclerosis

Designation


Marketing Exclusivity Aeolus Pharmaceuticals, Inc.

PO Box 14287; 79 T.W. Alexander Dr.

4401 Research

Research Triangle Park NC 27709

***************************************************************************************


1,1'-[1,4-phenylenebis(methylene)-bis-1,4,8,11-

tetraazacyclotetradecan

Trade Name:

Orphan Designation:

For combination use with filgrastim to improve the yield of progentor

cells in the apheresis product for subsequest stem cell transplantation

Designation following myelosuppressive or myeloablative chemotherapy


Marketing Exclusivity Genzyme Corporation

500 Kendall Street

Cambridge MA 02142

***************************************************************************************


1,2-bis(methylsulfonyl)-1-(2-chloroethyl)-2-

[(methylamino)carbonyl]hydrazine

Trade Name:

CloretazineOrphan Designation:

Treatment of acute myelogenous leukemia

Designation


Marketing Exclusivity Vion Pharmaceuticals, Inc.

Four Science Park

New Haven CT 06511

***************************************************************************************


1,5-(Butylimino)-1,5 dideoxy,D-glucitol

Trade Name:

Orphan Designation:

Treatment of Fabry's disease.

Designation


Marketing Exclusivity Oxford GlycoSciences

10, The Quadrant

Abington Science Park

United Kingdom

UNITED KINGDOM

***************************************************************************************


111Indium pentetreotide

Trade Name:

SomatoTherOrphan Designation:

Treatment of somatostatin receptor positive neuroendocrine tumors.

Designation


Marketing Exclusivity Louisiana State University Medical Center Foundation

1600 Canal St.

10th Floor

New Orleans LA 70112

***************************************************************************************


166Ho-DOTMP

Trade Name:

Orphan Designation:

Treatment of multiple myeloma.

Designation


Marketing Exclusivity NeoRx Corporation

410 W. Harrison Street

Seattle WA 98119-4007

***************************************************************************************


17 a-Hydroxyprogesterone caproate

Trade Name:

GestivaOrphan Designation:

Prevention of preterm birth in singleton pregnancies

Designation


Marketing Exclusivity Adeza Biomedical

1240 Elko Drive

Sunnyvale CA 94089

***************************************************************************************


17-alltlamino-17-demethoxygeldanamycin (17-AGG)

Trade Name:

Orphan Designation:

Treatment of multiple myeloma.

Designation


Marketing Exclusivity Kosan Biosciences, Inc

3832 Bay Center Place

Hayward CA 94545

***************************************************************************************


17-allylamino-17-demethoxygeldanamycin (17-AGG)

Trade Name:

Orphan Designation:

For the treatment of chronic myelogenous leukemia

Designation


Marketing Exclusivity Kosan Biosciences, Inc.

3832 Bay Center Place

Hayward CA 94545

***************************************************************************************


1-Deoxygalactonojirimycin

Trade Name:

Orphan Designation:

Treatment of Fabry Disease

Designation


Marketing Exclusivity Amicus Therapeutics, Inc.

6 Cedar Brook Drive

Cranbury NJ 08512

***************************************************************************************


2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylic

acid

Trade Name:

Orphan Designation:

Treatment of familial amyloid polyneuropathy

Designation


Marketing Exclusivity FoldRx Pharmaceuticals, Inc.

300 Technology Square

Cambridge MA 02139

***************************************************************************************


2-(3-diethylaminopropyl)-8,8-dipropyl-2-azaspiro [4,5]

decan dimaleate

Trade Name:

AtiprimodOrphan Designation:

Treatment of mulitple myeloma and associated bone resorption

Designation


Marketing Exclusivity Callisto Pharmaceuticals, Inc.

2 Executive Drive

Suite 450

Somerset NJ 08873

***************************************************************************************


2-(3-Diethylaminopropyl)-8,8-dipropyl-2-azaspiro[4,5]

decane dimaleate

Trade Name:

AtiprimodOrphan Designation:

Treatment of carcinoid tumors

Designation


Marketing Exclusivity Callisto Pharmaceuticals, Inc.

420 Lexington Avenue

New York NY 10170

***************************************************************************************


2',3',5'-tri-o-acetyluridine

Trade Name:

Orphan Designation:

Treatment of mitochondrial disease

Designation


Marketing Exclusivity Repligen Corporation

41 Seyon Street

Building 1, Suite 100

Waltham MA 02453

***************************************************************************************


2-0-Butyryl-1-0-octyl-myo-inositol 3,4,5,6-

tetrakisphosphate

Trade Name:

Orphan Designation:

Treatment of cystic fibrosis

Designation


Marketing Exclusivity Inologic, Inc.

101 Elliott Ave., West

Seattle WA 98119

***************************************************************************************


2-0-desulfated heparin

Trade Name:

AeropinOrphan Designation:

Treatment of cystic fibrosis.

Designation


Marketing Exclusivity Kennedy & Hoidal, M.D.'s

University of Utah Health Sciences Center

50 North Medical Drive, Room 4R240

Salt Lake City UT 84132

***************************************************************************************


20-mer complementary to Akt mRNA

Trade Name:

Orphan Designation:

Treatment of stomach cancer

Designation


Marketing Exclusivity Rexahn Corporation

9620 Medical center Drive

Rockville MD 20850

***************************************************************************************


20-mer oligonucleotide complementary to Akt mRNA

Trade Name:

Orphan Designation:

Treatment of pancreatic cancer

Designation



9620 Medical Center Drive

Rockville MD 20850

***************************************************************************************



Trade Name:

Orphan Designation:

Treatment of glioblastoma

Designation



9620 Medical center Drive

Rockville MD 20850

***************************************************************************************



Trade Name:

Orphan Designation:

Treatment of renal cell carcinoma

Designation




Rockville MD 20850

***************************************************************************************



Trade Name:

Orphan Designation:

Treatment of ovarian cancer

Designation




Rockville MD 20850

***************************************************************************************


2'-3'-dideoxyadenosine

Trade Name:

Orphan Designation:

Treatment of aquired immunodeficiency syndrome.

Designation


Marketing Exclusivity National Cancer Institute, Dct

NIH, Exec. Plaza N., Room 7-18

Bethesda MD 20892

***************************************************************************************


24,25 dihydroxycholecalciferol

Trade Name:

Orphan Designation:

Treatment of uremic osteodystrophy.

Designation


Marketing Exclusivity Lemmon Company

1510 Delp Drive

Kulpsville PA 19443

***************************************************************************************


2-chloroethyl-3-sarcosinamide-1-nitrosourea

Trade Name:

Orphan Designation:

Treatment for malignant gliomas

Designation


Marketing Exclusivity Lawrence Panasci, MD

Professor of Medicine, McGill University

3755 Cote Ste Catherine

Montreal, Quebec H3T 1E2

CANADA

***************************************************************************************


2-chloroethyl-3-sarcosinamide-1-nitrosourea

Trade Name:

SarmustineOrphan Designation:

Treatment for malignant glioma

Designation


Marketing Exclusivity Pangene Corporation

5500 Stewart Avenue

Fremont CA 94538

***************************************************************************************


2'-deoxycytidine

Trade Name:

Orphan Designation:

As a host-protective agent in the treatment of acute myelogenous

leukemia.

Designation


Marketing Exclusivity Grant, Steven M.D.

Massey Cancer Center, VCU

P.O. Box 980230

Richmond VA 23298-0230

***************************************************************************************


2-methoxyestradiol

Trade Name:

PulmoLAROrphan Designation:

Treatment of pulmonary arterial hypertension

Designation


Marketing Exclusivity PR Pharmaceuticals, Inc.

1716 Heath Parkway

Fort Collins CO 80524

***************************************************************************************


2-methoxyestradiol

Trade Name:

Panzem NCDOrphan Designation:

Treatment of ovarian cancer

Designation


Marketing Exclusivity EntreMed, Inc.


Rockville MD 20850

***************************************************************************************


2-methoxyestradiol

Trade Name:

PanzemOrphan Designation:

Treatment of multiforme glioblastoma

Designation




Rockville MD 20850

***************************************************************************************


2-methoxyestradiol

Trade Name:

PanzemOrphan Designation:

Treatment of multiple myeloma

Designation




Rockville MD 20850

***************************************************************************************


2'-O-methyl-phosphorothiolate oliogribonucleotide

Trade Name:

Orphan Designation:

Treatment of Duchenne muscular dystrophy

Designation


Marketing Exclusivity Prosena B.V.

Einsteinweg 55

NETHERLANDS

***************************************************************************************


3-(3,5-Dimethyl-1H-2ylmethylene)-1,3-dihydro-indol-

2-one

Trade Name:

Orphan Designation:

Treatment of von Hippel-Lindau disease.

Designation


Marketing Exclusivity Sugen, Inc.

230 East Grand Ave.


***************************************************************************************


3-(3,5-dimethyl-1H-2ylmethylene)-1,3-dihydro-indol-

2-one

Trade Name:

Orphan Designation:

Treatment of Kaposi's sarcoma.

Designation


Marketing Exclusivity Sugen, Inc.

230 East Grand Ave.

South San Francisco CA 94080-4811

***************************************************************************************


3,4-diaminopyridine

Trade Name:

Orphan Designation:

Treatment of Lambert-Eaton myasthenic syndrome.

Designation


Marketing Exclusivity Jacobus Pharmaceutical Company

37 Cleveland Avenue

P.O. Box 5290

Princeton NJ 08540

***************************************************************************************


3,5,3'-triiodothyroacetate

Trade Name:

Orphan Designation:

Treatment of well-differentiated papillary, follicular or combined

papillary/follicular carcinomas of the thyroid gland.

Designation


Marketing Exclusivity Elliot Danforth, Jr., M.D.

University of Vermont

84 Beartown Road

Underhill VT 05489

***************************************************************************************


3'-azido-2',3'dideoxyuridine

Trade Name:

AZDUOrphan Designation:

Treatment of acquired immunodeficiency syndrome.

Designation


Marketing Exclusivity Berlex Laboratories, Inc.

1401 Harbor Bay Parkway

Alameda CA 94501

***************************************************************************************


4-(3-Methanesulfonyl-phenyl)-1-propylpiperidine HCl

Trade Name:

Orphan Designation:

Treatment of Huntington disease.

Designation


Marketing Exclusivity A. Carlsson Research AB

Joakim Tedroff, M.D.

S-412 46 Goteborg

SWEDEN

***************************************************************************************


4,5-dibromorhodamine 123

Trade Name:

Theralux Irradiation DeviceOrphan Designation:

Treatment of chronic myelogenous leukemia

Designation


Marketing Exclusivity Kiadis Pharma Canada, Inc.

2525 Marie-Curie

Saint-Laurent (Quebec) H4S 2E1

CANADA

***************************************************************************************


40SD02

Trade Name:

Orphan Designation:

Treatment of chronic iron overload resulting from conventional

transfusional treatment of beta-thalassemia major and sickle cell

Designation anemia.


Marketing Exclusivity Biomedical Frontiers, Inc.

1095 10th Ave., S.E.

Minneapolis MN 55414

***************************************************************************************


4-Aminopyridine

Trade Name:

Orphan Designation:

Treatment chronic functional motor and sensory deficits from

Guillain-Barre syndrome

Designation


Marketing Exclusivity Neurorecovery, Inc.

Crescent Center

Suite 930

Memphis TN 38119

***************************************************************************************


4-aminosalicylic acid

Trade Name:

Paser GranulesOrphan Designation:

Treatment of acute flares in pediatric patients with ileo-cecal Crohn's

disease

Designation


Marketing Exclusivity Jacobus Pharmaceutical Co., Inc.

37 Cleveland Lane

Princeton NJ 08540

***************************************************************************************


4-aminosalicylic acid

Trade Name:

Pamisyl (P-D), Rezipas (Squibb)Orphan Designation:

Treatment of mild to moderate ulcerative colitis in patients intolerant

to sulfasalazine.

Designation


Marketing Exclusivity Beeken, Warren M.D.

University Of Vermont

Given C-317

Burlington VT 05405

***************************************************************************************


4-cholest-en-3-one, oxime

Trade Name:

Orphan Designation:

Treatment of amyotrophic lateral sclerosis

Designation


Marketing Exclusivity Trophos SA

Parc scientifique de Lumigny, Case 931

1322 Marseille cedex

FRANCE

***************************************************************************************


4-cyano-N-[2-(1-cyclohexen-1-yl)-4-[1-

[dimethylamino)acetyl]-4-piperidinyl]phenyl]-1H-

imidazole-2-carboxamide monohydrochloride

Trade Name:

Orphan Designation:

Treatment of acute myeloid leukemia

Designation


Marketing Exclusivity Johnson & Johnson Pharmaceutical Research & Dev,

920 U S Highway 202

P.O. Box 300

Raritan NJ 08869

***************************************************************************************


4-trifluoromethyl-N-(3.3a.4.4a.5,5a,6,6a-octahydro-

1,3-dioxo-4,6ethenocycloprop[f]isoindol-2(1H)-yl)-

Trade Name:

Orphan Designation:

Treatment of smallpox.

Designation


Marketing Exclusivity SIGA Technologies, Inc.

4575 SW Research Way

Corvallis OR 97333

***************************************************************************************


4-trifluoromethyl-N-(3.3a.4.4a.5,5a,6,6a-octahydro-

1,3-dioxo-4,6ethenocycloprop[f]isoindol-2(1H)-yl)-

Trade Name:

Orphan Designation:

post exposure prophylaxis against smallpox

Designation


Marketing Exclusivity SIGA Technologies, Inc.

4575 SW Research Way

Corvallis OR 97333

***************************************************************************************


5,12-Naphthacenedione, 10-[[3-amino-2,3,6-trideoxy-

4-O-(phenylmethyl)-a-L-lyxo-hexopyranosyl]oxy]-

7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-

(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S,10S)-

Trade Name:

Orphan Designation:

Treatment of malignant gliomas

Designation


Marketing Exclusivity Reata Pharmaceuticals, Inc.

1950 N. Stemmons Freeway

Dallas TX 75207-3199

***************************************************************************************


5,5',5"-[Phosphinothioylidyne-tris(imino-2,1-

ethanediyl)]tris[5-methylchelidoninium]trihydroide

hexahydrochloride

Trade Name:

Orphan Designation:


Designation


Marketing Exclusivity Now Pharm AG

241, route d'Arlon

L-1150

LUXEMBOURG

***************************************************************************************


5,6-dihydro-5-azacytidine

Trade Name:

Orphan Designation:

Treatment of malignant mesothelioma.

Designation


Marketing Exclusivity ILEX Oncology, Inc.

4545 Horizon Hill Blvd.

San Antonio TX 78229-2263

***************************************************************************************


506U78

Trade Name:

Orphan Designation:

Treatment of chronic lymphocytic leukemia.

Designation


Marketing Exclusivity GlaxoSmithKline

Five Moore Dr.

P.O. Box 13398

Research Triangle Park NC 27709-3398

***************************************************************************************


5a8, monoclonal antibody to CD4

Trade Name:

Orphan Designation:

For use in post-exposure prophylaxis for occupational exposure to

human immunodeficiency virus.

Designation


Marketing Exclusivity Biogen, Inc.

14 Cambridge Center

Cambridge MA 02142

***************************************************************************************


5-aza-2'-deoxycytidine

Trade Name:

Orphan Designation:

Treatment of acute leukemia.

Designation


Marketing Exclusivity SuperGen, Inc.

4140 Dublin Blvd.

Suite 200

Dublin CA 94568

***************************************************************************************


5-hydroxymethyl-2-furfuraldehyde

Trade Name:

Orphan Designation:

Treatment of sickle cell disease

Designation


Marketing Exclusivity Xechem International, Inc.

New Brunswick Technoloogy Center

Building 1, Suite 310

New Brunswick NJ 08901-3279

***************************************************************************************


5-iodo-2-pytimidinone-2'-deoxyribose

Trade Name:

Orphan Designation:

Treatment of malginant glioma

Designation


Marketing Exclusivity Hana Biosciences, Inc.

7000 Shoreline Court

Suite 370


***************************************************************************************


5-methyl-1-phenyl-2-(1H)-pyridone(CAS 53179-13-8)

Trade Name:

PirfenidoneOrphan Designation:

Treatment of idiopathic pulmonary fibrosis

Designation


Marketing Exclusivity InterMune, Inc.

3280 Bayshore Blvd

Brisbane CA 94005

***************************************************************************************


6,8-bis-benzylsulfanyl-octanoic acid

Trade Name:

Orphan Designation:


Designation


Marketing Exclusivity Cornerstone Pharmaceuticals, Inc.

25 Health Science Drive

Stony Brook NY 11790

***************************************************************************************


6-hydroxymethylacylfulvene

Trade Name:

Orphan Designation:

Treatment of histologically confirmed advanced or metastatic

pancreatic cancer.

Designation


Marketing Exclusivity MGI Pharma, Inc.

5775 West Old Shakopee

Suite 100

Bloomington MN 55437-3107

***************************************************************************************


8 Cyclopentyl 1,3-dipropylxanthine

Trade Name:

Orphan Designation:


Designation


Marketing Exclusivity SciClone Pharmaceuticals, Inc.

901 Mariner's Island Boulevard

San Mateo CA 94404-1593

***************************************************************************************


8-methoxsalen

Trade Name:

UvadexOrphan Designation:

For use in conjunction with the UVAR photopheresis to treat diffuse

systemic sclerosis.

Designation


Marketing Exclusivity Therakos, Inc.

Oaklands Corporate Center

437 Creamery Way

Exton PA 19341

***************************************************************************************


8-methoxsalen

Trade Name:

UvadexOrphan Designation:

For the prevention of acute rejection of cardiac allografts.

Designation


Marketing Exclusivity Therakos, Inc.

Oaklands Corporate Center

437 Creamery Way

Exton PA 19341

***************************************************************************************


90Y-hPAMA4

Trade Name:

PAN-CideOrphan Designation:


Designation


Marketing Exclusivity Immunomedics, Inc.

300 American Road

Morris Plains NJ 07950

***************************************************************************************


9-cis-retinoic acid

Trade Name:

Orphan Designation:

Prevention of retinal detachment due to proliferative

vitreoretinopathy.

Designation


Marketing Exclusivity Allergan, Inc.

2525 Dupont Drive

P.O. Box 19534

Irvine CA 92623-9534

***************************************************************************************


9-nitro-20-(S)-camptothecin

Trade Name:

Orphan Designation:

Treatment of pancreatic cancer.

Designation


Marketing Exclusivity SuperGen, Inc.

4140 Dublin Blvd.

Suite 200

Dublin CA 94568

***************************************************************************************


9-nitro-20-(S)-camptothecinTreatment of pediatric HIV-infection/AIDS patients

Trade Name:

CamvirexOrphan Designation:

Treatment of pediatric HIV infection/AIDS

Designation


Marketing Exclusivity NovoMed Pharmaceuticals, Inc.

P.O. Box 900

Germantown MD 20875-0900

***************************************************************************************


a-(3-aminophthalimido) glutaramide

Trade Name:

ActimidOrphan Designation:

Treatment of multiple myeloma

Designation


Marketing Exclusivity Celgene Corporation

7 Powder Horn Drive

Warren NJ 07059

***************************************************************************************


A10 & AS2-1 Antineoplaston

Trade Name:

Orphan Designation:

Treatment for patients with brain stem glioma

Designation


Marketing Exclusivity Burzynski Research Institute, Inc.

9432 Old Katy Road

Houston TX 77055

***************************************************************************************


Abetimus

Trade Name:

Orphan Designation:

Treatment of lupus nephritis.

Designation


Marketing Exclusivity La Jolla Pharmaceutical Co.

6455 Nancy Ridge Dr.

San Diego CA 92121

***************************************************************************************


ACA125

Trade Name:

Orphan Designation:

Treatment of epithelial ovarian cancer

Designation


Marketing Exclusivity Menarini Ricerche S.p.A.

Via Tito Speri 10

Pomezia Roma

ITALY

***************************************************************************************


Acetylcysteine

Trade Name:

Mucomyst/Mucomyst 10 IVOrphan Designation:

Intravenous treatment of patients presenting with moderate to severe

acetaminophen overdose.

Designation


Marketing Exclusivity Bristol-Myers Squibb Company

P.O. Box 4500

Princeton NJ 08543-4500

***************************************************************************************


acetylcysteineFor the use of Acetadote(registered TM) Injection, administered

intravenously within 8 to 10 hours after ingestion of a potentially

heptotoxic quantity of acetaminophen, to prevent or lessen hepatic

Trade Name:injur

AcetadoteOrphan Designation:

For the intravenous treatment of moderate to severe acetaminophen

overdose

Designation


Marketing Exclusivity Cumberland Pharmaceuticals, Inc.

1/23/2004209 10th Street South

Suite 332

Nashville TN 37203

***************************************************************************************


Acid sphingomyelinase

Trade Name:

Orphan Designation:

Treatment of Niemann-Pick disease type B.

Designation



One Kendall Square

Cambridge MA 02139

***************************************************************************************


Aconiazide

Trade Name:

Orphan Designation:

Treatment of tuberculosis.

Designation


Marketing Exclusivity Lincoln Diagnostics

P.O. Box 1128

Decatur IL 62525

***************************************************************************************


adalimumab

Trade Name:

HumiraOrphan Designation:

Treatment of pediatric patients with moderately to severely active

Crohn's disease.

Designation


Marketing Exclusivity Abbott Laboratories

200 Abbott Park Road

Abbott Park IL 60064-6188

***************************************************************************************


Adalimumab

Trade Name:

HumiraOrphan Designation:

Treatment of juvenile rheumatoid arthritis

Designation


Marketing Exclusivity Abbott Laboratories

200 Abbott Park Road

Abbott Park IL 60064-6157

***************************************************************************************


Adeno-associated viral vector containing the gene for

human coagulation factor IX

Trade Name:

Coagulin-BOrphan Designation:

Intramuscular treatment of patients with moderate to severe

hemophilia

Designation


Marketing Exclusivity Avigen, Inc.


Alameda CA 94502

***************************************************************************************


Adeno-associated viral vector containing the gene for

human coagulation factor IX

Trade Name:

Coagulin-BOrphan Designation:

Intrahepatic treatment of patients with moderate to severe

hemophilia

Designation


Marketing Exclusivity Avigen, Inc.


Alameda CA 94502

***************************************************************************************


Adeno-associated viral-based vector cystic fibrosis

gene therapy

Trade Name:

Orphan Designation:


Designation


Marketing Exclusivity Targeted Genetics Corporation

1100 Olive Way, Suite 100

Seattle WA 98101

***************************************************************************************


Adenosine

Trade Name:

Orphan Designation:

For use in conjunction with BCNU in the treatment of brain tumors.

Designation


Marketing Exclusivity Medco Research, Inc.

8455 Beverly Boulevard

Suite 308

Los Angeles CA 90048

***************************************************************************************


Adenoviral vector expressing Herpes simplex virus

thymidine kinase gene

Trade Name:

Orphan Designation:

Treatment of malignant brain tumors

Designation


Marketing Exclusivity Advantagene, Inc.

160 Paulson Road

Waban MA 02468

***************************************************************************************


Adenovirus-based vector Factor VIII complementary

DNA to somatic cells

Trade Name:

MiniAdFVIIIOrphan Designation:

Treatment of hemophilia A.

Designation


Marketing Exclusivity GenStar Therapeutics Corporation

10835 Altman Row

Suite 150

San Diego CA 92121

***************************************************************************************


adenovirus-mediated herpes simplex virus-thymidine

kinase gene

Trade Name:

Orphan Designation:

Use with gancyclovir in the treatment of malignant glioma

Designation


Marketing Exclusivity Ark Therapeutics Ltd

6 Warren Mews

London W1T6AR

London

UNITED KINGDOM

***************************************************************************************


Aerosolized pooled immune globulin

Trade Name:

Orphan Designation:

Treatment of respiratory syncytial virus lower respiratory tract disease.

Designation


Marketing Exclusivity Pediatric Pharmaceuticals, Inc.

718 Bradford Avenue

Westfield NJ 07090

***************************************************************************************


a-Galactosidase A

Trade Name:

Plant-Produced Human a-Glactosidase AOrphan Designation:

Treatment of Fabry's disease

Designation


Marketing Exclusivity Large Scale Biology Corporation

3333 Vacaville Parkway

Suite 1000

Vacaville CA 95688

***************************************************************************************


Aglycosyl anti-CD3 monoclonal antibody

Trade Name:

Orphan Designation:

Treatment of new-onset type I diabetes mellitus

Designation


Marketing Exclusivity TolerRX, Inc.


Cambridge MA 02139

***************************************************************************************


AI-RSA

Trade Name:

Orphan Designation:

Treatment of autoimmune uveitis.

Designation


Marketing Exclusivity AutoImmune, Inc.

128 Spring Street

Lexington MA 02173

***************************************************************************************


AlbendazoleTreatment of parenchymal neurocysticercosis due to active lesions

caused by larval forms of the pork tapeworm, Taenia solium.

Trade Name:

AlbenzaOrphan Designation:

Treatment of neurocysticercosis due to Taenia solium as: 1)

chemotherapy of parenchymal, subarachnoidal and racemose (cysts

Designation in spinal fluid) neurocysticercosis in symptomatic cases and 2)

1/18/1996prophylaxis of epilepsy and other sequelae in asymptomatic

Sponsor and Address

Marketing Exclusivity SmithKline Beecham Pharmaceuticals

6/11/1996One Franklin Plaza

P.O. Box 7929

Philadelphia PA 19101

***************************************************************************************


AlbendazoleTreatment of cystic hydatid disease of the liver, lung, and

peritoneum, caused by the larval form of the dog tapeworm,

Echinococcus granulosus.

Trade Name:

AlbenzaOrphan Designation:

Treatment of hydatid disease (cystic echinococcosis due to E.

granulosus larvae or alveolar echinococcosis due to E. multilocularis

Designation larvae).


Marketing Exclusivity SmithKline Beecham Pharmaceuticals

6/11/1996One Franklin Plaza

P.O. Box 7929


***************************************************************************************


Albuterol

Trade Name:

Orphan Designation:

Prevention of paralysis due to spinal cord injury

Designation


Marketing Exclusivity MotoGen, Inc.

3 Pine View Road

Mount Kisco NY 10549

***************************************************************************************


Aldesleukin

Trade Name:

ProleukinOrphan Designation:

Treatment of primary immunodeficiency disease associated with T-

cell defects.

Designation


Marketing Exclusivity Chiron Corporation

4560 Horton Street

Emeryville CA 94608-2916

***************************************************************************************


AldesleukinTreatment of adults (>18 years old) with metastatic renal cell

carcinoma.

Trade Name:


Treatment of metastatic renal cell carcinoma.

Designation



5/5/19924560 Horton Street


***************************************************************************************


AldesleukinTreatment of adults with metastatic melanoma.

Trade Name:


Treatment of metastatic melanoma.

Designation



1/9/19984560 Horton Street


***************************************************************************************


Aldesleukin

Trade Name:


For the treatment non-Hodgkin's lymphoma.

Designation



4560 Horton St.


***************************************************************************************


alemtuzumabThe treatment of patients with B-cell chronic lymphocytic leukemia

who have been treated with alkylating agents and who have failed

fludarabine therapy.

Trade Name:

CampathOrphan Designation:

Treatment of chronic lymphocytic leukemia.

Designation



5/7/20014545 Horizon Hill Blvd.

San Antonio TX 78229-2263

***************************************************************************************


alendronate

Trade Name:

FosamaxOrphan Designation:

Treatment of osteogenesis imperfecta in pediatric patients 4 years of

age and older

Designation


Marketing Exclusivity Merck & Co., Inc.

126 East Lincoln Ave.

Rahway NJ 07065-0900

***************************************************************************************


Alendronate disodium

Trade Name:

FosamaxOrphan Designation:

Treatment of the bone manifestations of Gaucher disease

Designation


Marketing Exclusivity Richard J. Wenstrup, M.D.

Division of Human Genetics

Children's Hospital Research Foundation

Cincinnati OH 45229-3039

***************************************************************************************


Alfentanil

Trade Name:

Orphan Designation:

Management of postherpetic neuralgia

Designation


Marketing Exclusivity Cinergen, LLC

146 Medinah Drive

Blue Bell PA 19422-3212

***************************************************************************************


Alfentanil

Trade Name:

Orphan Designation:

Treatment of painful HIV-associated neuropathy

Designation


Marketing Exclusivity Cinergen, LLC

146 Medinah Drive

Blue Bell PA 19422-3212

***************************************************************************************


Alglucerase injection

Trade Name:

CeredaseOrphan Designation:

Replacement therapy in patients with Type II and III Gaucher's

disease.

Designation



One Kendall Square

Cambridge MA 02139-1562

***************************************************************************************


Alglucerase injection

Trade Name:

CeredaseOrphan Designation:

For replacement therapy in patients with Gaucher's disease type I.

Designation



4/5/1991One Kendall Square

Cambridge MA 02139-1562

***************************************************************************************


AlitretinoinTopical treatment of cutaneous lesions in patients with AIDS-related

Kaposi's sarcoma.

Trade Name:

PanretinOrphan Designation:

Topical treatment of cutaneous lesions in patients with AIDS-related

Kaposi's sarcoma.

Designation


Marketing Exclusivity Ligand Pharmaceuticals Inc.

2/2/199910275 Science Center Drive

San Diego CA 92121-1117

***************************************************************************************


Alitretinoin

Trade Name:

PanretinOrphan Designation:

Treatment of acute promyelocytic leukemia

Designation


Marketing Exclusivity Ligand Pharmaceuticals, Inc.

10275 Science Center Dr.

San Diego CA 92121-1117

***************************************************************************************


allantoin

Trade Name:

AlwextinOrphan Designation:

Treatment of skin blistering and erosions associated with inherited

epidermolysis bullosa

Designation


Marketing Exclusivity Alwyn Company, Inc.

2301 Highway 60 East

Lake Crystal MN 56055

***************************************************************************************


Allogeneic human retinal pigment epithelial cells on

gelatin microcarriers

Trade Name:

SpheramineOrphan Designation:

Treatment of Hoehn and Yahr stage 3 and 4 Parkinson's disease.

Designation


Marketing Exclusivity Berlex, Inc.

Post Office Box 1000

50 Division Street, Suite 503

Montville NJ 07045-1000

***************************************************************************************


Allogeneic peripheral blood mononuclear cells

sensitized against patient alloantigens by mixed

Trade Name:

CYTOIMPLANTOrphan Designation:


Designation


Marketing Exclusivity Applied Immunotherapeutics, LLC

14132 E. Firestone Boulevard

Santa Fe Springs CA 90670

***************************************************************************************


Allogeneic retinal epithelial cells transfected with

plasmid vector expressing ciliary neurotrophic growth

Trade Name:

Orphan Designation:

Treatment of retinitis pigmentosa

Designation


Marketing Exclusivity Neurotech USA, Inc.

6 Blackstone Valley Place

Lincoln RI 02865

***************************************************************************************


Allogeneic T-cells cultured with anti-CD3 and IL-2;

transduced with retroviral vector (SFCMM-3),

expressing herpes simplex 1 virus-thymidine kinase

(HSV-TK) and truncated low affinity nerve growth

factor receptor; selected with anti-low affinity nerve gro

Trade Name:

Orphan Designation:

Immunotherapy for acceleration of T-cell reconstitution in patients

undergoing allogeneic hematopoietic stem cell transplantation

Designation


Marketing Exclusivity MolMed S.p.A.

Via Olgettina 58

Milan 20132

ITALY

***************************************************************************************


Allopurinol riboside

Trade Name:

Orphan Designation:

Treatment of cutaneous and visceral leishmaniasis.

Designation


Marketing Exclusivity Burroughs Wellcome Company

3030 Cornwallis Road

P.O. Box 12700


***************************************************************************************


Allopurinol riboside

Trade Name:

Orphan Designation:

Treatment of Chagas' disease.

Designation




P.O. Box 12700


***************************************************************************************


Allopurinol sodiumManagement of patients with leukemia, lymphoma, and solid tumor

malignancies who are receiving cancer therapy which causes

elevations of serum and urinary uric acid levels and who cannot

Trade Name:tolerate oral therapy.

Aloprim for InjectionOrphan Designation:

Management of patients with leukemia, lymphoma, and solid tumor

malignancies who are receiving cancer therapy which causes

Designation elevations of serum and urinary uric acid levels and who cannot

10/16/1992Sponsor and Addresstolerate oral therapy.

Marketing Exclusivity Catalytica Pharmaceuticals, Inc

5/17/1996PO Box 1887

Greenville NC 27835-1887

***************************************************************************************


Allopurinol sodium

Trade Name:

Orphan Designation:

Ex-vivo preservation of cadaveric kidneys for transplantation

Designation




Research Triangle Pk NC 27709

***************************************************************************************


Alpha-1-acid glycoprotein

Trade Name:

Orphan Designation:

Treatment of cocaine overdose

Designation


Marketing Exclusivity Bio Products Laboratory

Dagger Lane, Elstree

WD6 3BX

UNITED KINGDOM

***************************************************************************************


Alpha-1-acid glycoprotein

Trade Name:

Orphan Designation:

Treatment of tricyclic antidepressant poisoning

Designation


Marketing Exclusivity Bio Products Laboratory

Dagger Lane

Elstree, Hertfordshire

UNITED KINGDOM

***************************************************************************************


Alpha-1-antitrypsin (recombinant DNA Origin)

Trade Name:

Orphan Designation:

As supplementation therapy for alpha-1-antitrypsin deficiency in the

ZZ phenotype population.

Designation



4560 Horton Street


***************************************************************************************


Alpha1-Proteinase Inhibitor (Human)

Trade Name:

ARC-APIOrphan Designation:

Treatment of cystic fibrosis

Designation


Marketing Exclusivity Kamada Ltd.

Kiryat Weizmann

ISRAEL

***************************************************************************************


Alpha1-proteinase inhibitor (human)

Trade Name:

Orphan Designation:

For slowing the progression of emphysema in alpha1-antitrypsin

deficient patients.

Designation


Marketing Exclusivity Aventis Behring L.L.C.

1020 First Ave.

PO Box 61501

King of Prussia PA 19406-0901

***************************************************************************************


Alpha1-proteinase inhibitor (human)For chronic replacement therapy of individuals having congenital

deficiency of alpha1- proteinase inhibitor with clinically

demonstrable panacinar emphysema.

Trade Name:

ProlastinOrphan Designation:

For replacement therapy in the alpha-1-proteinase inhibitor

congenital deficiency state.

Designation


Marketing Exclusivity Bayer Corporation

12/2/1987Pharmaceutical Division, Biological Products

400 Morgan Lane

New Haven CT 06516

***************************************************************************************


Alpha1-Proteinase Inhibitor (Human) [API]

Trade Name:

Orphan Designation:

Chronic inhalation therapy of individuals with congenital deficiency

of alpha1-proteinase inhibitor with demonstrable panacinar

Designation emphysema


Marketing Exclusivity Kamada Ltd.

Kiryat Weizmann

ISRAEL

***************************************************************************************


Alpha-galactosidase A

Trade Name:

FabraseOrphan Designation:

Treatment of Fabry's disease.

Designation


Marketing Exclusivity Desnick, Robert J. M.D.

The Mount Sinai School Of Medicine

Fifth Avenue at 100th Street, Box 1203

New York NY 10029

***************************************************************************************



Trade Name:

CC-galactosidaseOrphan Designation:

Treatment of alpha-galactosidase A deficiency (Fabry's disease).

Designation


Marketing Exclusivity David Calhoun, Ph.D.

Department of Chemistry

Convent Avenue & 138th Street

New York NY 10031

***************************************************************************************



Trade Name:

ReplagalOrphan Designation:

Long-term enzyme replacement therapy for the treatment of Fabry

disease.

Designation


Marketing Exclusivity Shire Human Genetic Therapies, Inc.

700 Main Street

Cambridge MA 02139

***************************************************************************************


Alpha-melanocyte stimulating hormone

Trade Name:

Orphan Designation:

Prevention and treatment of intrinsic acute renal failure due to

ischemia.

Designation


Marketing Exclusivity National Institute of Diabetes, and Digestive and Kidney Diseases

National Institutes of Health, 31 Center Drive MSC

Building 31, Room 9N-222

Bethesda MD 20892-2560

***************************************************************************************


Alpha-tocopherol quinone

Trade Name:

Orphan Designation:

Treatment of inherited mitochondrial respiratory chain diseases

Designation


Marketing Exclusivity Edison Pharmaceuticals, Inc.

5941 Optical Court

San Jose CA 95138

***************************************************************************************


Alprostadil

Trade Name:

Orphan Designation:

Treatment of severe peripheral arterial occlusive disease (critical limb

ischemia) in patients where other procedures, grafts or angioplasty,

Designation are not indicated.


Marketing Exclusivity Schwarz Pharma, Inc.

P.O. Box 2038

Milwaukee WI 53201

***************************************************************************************


alteplase

Trade Name:

ActivaseOrphan Designation:

Treatment of intraventricular hemmorage associated with

intracerebral hemmorrhage

Designation


Marketing Exclusivity Daniel F. Hanley, MD

Johns Hopkins University

600 N. Wolfe St., Jefferson 1-109

Baltimore MD 21287

***************************************************************************************


Altretamine

Trade Name:

HexalenOrphan Designation:

Treatment of advanced adenocarcinoma of the ovary.

Designation


Marketing Exclusivity Medimmune Oncology, Inc.

12/26/1990One Tower Bridge

100 Front Street, Suite 400

Conshohocken PA 19428

***************************************************************************************


Ambrisentan

Trade Name:

Orphan Designation:

Treatment of pulmonary arterial hypertension

Designation


Marketing Exclusivity Gilead Colorado

7575 West 103rd Avenue

Suite 102

Westminister CO 80021-5426

***************************************************************************************


AMG 531

Trade Name:

Orphan Designation:

Treatment of immune thrombocytopenic purpura.

Designation


Marketing Exclusivity Amgen, Inc.

One Amgen Center Drive

Thousand Oaks CA 91320-1799

***************************************************************************************


Amifostine

Trade Name:

EthyolOrphan Designation:

Treatment of myelodysplastic syndromes.

Designation



One MedImmune Way

Gaithersburg MD 20878

***************************************************************************************


Amifostine

Trade Name:


For use as a chemoprotective agent for cisplatin in the treatment of

metastatic melanoma.

Designation



One MedImmune Way


***************************************************************************************


Amifostine

Trade Name:


For use as a chemoprotective agent for cyclophosphamide in the

treatment of advanced ovarian carcinoma.

Designation



One MedImmune Way


***************************************************************************************


AmifostineTo reduce the cumulative renal toxicity associated with repeated

administration of cisplatin in patients with advanced ovarian cancer.

Trade Name:


For use as a chemoprotective agent for cisplatin in the treatment of

advanced ovarian carcinoma.

Designation





West Conshohocken PA 19428

***************************************************************************************


AmifostineReduction of the incidence of moderate to severe xerostomia in

patients undergoing post-operative radiation treatment for head and

neck cancer, where the radiation port includes a substantial portion of

Trade Name: the parotid glands.


Reduction of the incidence of moderate to severe xerostomia in

patients undergoing post-operative radiation treatment for head and

Designation neck cancer.





Conshohocken PA 19428

***************************************************************************************


Amifostine

Trade Name:


For the reduction of the incidence and severity of toxicities associated

with cisplatin administration.

Designation



One MedImmune Way


***************************************************************************************


Amikacin

Trade Name:

SLIT AmikacinOrphan Designation:

Treatment of bronchopulmonary Pseudomonas aeruginosa infections

in cystic fibrosis patients

Designation


Marketing Exclusivity Transave, Inc.

11 Deer Park Drive

Monmouth Junction NJ 08852-1923

***************************************************************************************


Amiloride HCl solution for inhalation

Trade Name:

Orphan Designation:


Designation


Marketing Exclusivity Glaxo Wellcome Research and Development

5 Moore Drive

PO Box 13398


***************************************************************************************


Aminocaproic acid

Trade Name:

CaprogelOrphan Designation:

For the topical treatment of traumatic hyphema of the eye.

Designation


Marketing Exclusivity Eastern Virginia Medical School

Department of Ophthalomology

880 Kempsville Road, Suite 2500

Norfolk VA 23502-3990

***************************************************************************************


Aminosalicylate sodium

Trade Name:

Orphan Designation:

Treatment of Crohn's disease.

Designation


Marketing Exclusivity Syncom Pharmaceuticals, Inc.

66 Hanover Road

Florham Park NJ 07932

***************************************************************************************


Aminosalicylic acidTreatment of tuberculosis

Trade Name:

Paser GranulesOrphan Designation:

Treatment of tuberculosis infections

Designation


Marketing Exclusivity Jacobus Pharmaceutical Company

6/30/199437 Cleveland Lane

P.O. Box 5290

Princeton NJ 08540

***************************************************************************************


Aminosidine

Trade Name:

ParomomycinOrphan Designation:

Treatment of visceral leishmaniasis

Designation


Marketing Exclusivity The Institute for One World Health

580 California Street

San Francisco CA 94104

***************************************************************************************


Aminosidine

Trade Name:

ParomomycinOrphan Designation:

Treatment of visceral leishmaniasis (kala-azar).

Designation


Marketing Exclusivity Kanyok, Thomas P. Pharm.D.

University of Illinois at Chicago College of Pharm

833 South Wood Street (m/c886) Rm. 176

Chicago IL 60612

***************************************************************************************


Aminosidine

Trade Name:

GabbromicinaOrphan Designation:

Treatment of tuberculosis.

Designation



University Of Illinois At Chicago College of Pharm


Chicago IL 60612

***************************************************************************************


Aminosidine

Trade Name:

GabbromicinaOrphan Designation:

Treatment of Mycobacterium avium complex.

Designation



University of Illinois at Chicago College of Pharm


Chicago IL 60612

***************************************************************************************


Amiodarone

Trade Name:

Amio-AqueousOrphan Designation:

Treatment of incessant ventricular tachycardia.

Designation


Marketing Exclusivity Academic Pharmaceuticals, Inc.

21 N. Skokie Valley Highway

Suite G3

Lake Bluff IL 60044

***************************************************************************************


Amiodarone HClFor initiation of treatment and prophylaxis of frequently recurring

ventricular fibrillation and hemodynamically unstable ventricular

tachycardia in patients refractory to other therapy.

Trade Name:

CordaroneOrphan Designation:

For the acute treatment and prophylaxis of life-threatening ventricular

tachycardia or ventricular fibrillation.

Designation


Marketing Exclusivity Wyeth-Ayerst Laboratories

8/3/1995P.O. Box 8299


***************************************************************************************


Ammonium tetrathiomolybdate

Trade Name:

Orphan Designation:

Treatment of Wilson's disease.

Designation


Marketing Exclusivity Brewer, George J. , M.D.

University Of Michigan Medical School

4708 Medical Science Building II 0618

Ann Arbor MI 48109

***************************************************************************************


amonafide L-malate

Trade Name:

XanafideOrphan Designation:

Treatment of acute myeloid leukemia.

Designation


Marketing Exclusivity Xanthus Pharmaceuticals, Inc.


Cambridge MA 02139

***************************************************************************************


Amphotericin B inhalation powder

Trade Name:

Orphan Designation:

Prevention of pulmonary fungal infections in patients at risk for

aspergillosis due to immunosuppressive therapy including those

Designation receiving organ or stem cell transplants, or teated with chemotherapy

12/15/2005or radiation for hematologic malignancies

Sponsor and Address

Marketing Exclusivity Nektar Therapeutics

150 Industrial Road

San Carlos CA 94070-6256

***************************************************************************************


Amphotericin B lipid complex

Trade Name:

AbelcetOrphan Designation:

Treatment of invasive protothecosis.

Designation


Marketing Exclusivity The Liposome Company, Inc.

One Research Way

Princeton NJ 08540

***************************************************************************************



Trade Name:


Treatment of invasive sporotrichosis.

Designation



One Research Way

Princeton NJ 08540

***************************************************************************************



Trade Name:


Treatment of invasive coccidioidomycosis.

Designation



One Research Way

Princeton NJ 08540

***************************************************************************************



Trade Name:


Treatment of invasive zygomycosis.

Designation



One Research Way

Princeton NJ 08540

***************************************************************************************



Trade Name:


Treatment of invasive candidiasis.

Designation



One Research Way

Princeton NJ 08540

***************************************************************************************


Amphotericin B lipid complexTreatment of invasive fungal infections in patients who are refractory

to or intolerant of conventional amphotericin B therapy.

Trade Name:


Treatment of invasive fungal infections.

Designation


Marketing Exclusivity Liposome Company, Inc.

10/18/1996One Research Way

Princeton NJ 08540

***************************************************************************************


Amsacrine

Trade Name:

AmsidylOrphan Designation:

Treatment of acute adult leukemia.

Designation


Marketing Exclusivity Warner-Lambert Company

Parke-Davis Pharmaceutical Research Division

2800 Plymouth Road

Ann Arbor MI 48106

***************************************************************************************


Amyl nitrite, sodium nitrite, sodium thiosulfate

Trade Name:

Cyanide Antidote KitOrphan Designation:

Treatment of cyanide poisoning

Designation


Marketing Exclusivity Akorn, Inc.

2500 Millbrook Drive

Buffalo Grove IL 60089

***************************************************************************************


Anagrelide

Trade Name:

AgrylinOrphan Designation:

Treatment of thrombocytosis in chronic myelogenous leukemia.

Designation


Marketing Exclusivity Roberts Pharmaceutical Corp.

Meridian Center II

4 Industrial Way West

Eatontown NJ 07724-2274

***************************************************************************************


AnagrelideTreatment of patients with essential thrombocythemia to reduce the

elevated platelet count and the risk of thrombosis and to ameliorate

associated symptoms.

Trade Name:


Treatment of essential thrombocythemia.

Designation



3/14/1997Meridian Center III


Eatontown NJ 07724

***************************************************************************************


Anagrelide

Trade Name:


Treatment of polycythemia vera.

Designation



Meridian Center II


Eatontown NJ 07724-2274

***************************************************************************************


Ananain, comosain

Trade Name:

VianainOrphan Designation:

For the enzymatic debridement of severe burns.

Designation



One Kendall Square

Cambridge MA 02139

***************************************************************************************


Anaritide acetate

Trade Name:

AuriculinOrphan Designation:

Treatment of patients with acute renal failure.

Designation


Marketing Exclusivity Scios, Inc.

2450 Bayshore Parkway

Mountain View CA 94043

***************************************************************************************


Anaritide acetate

Trade Name:

AuriculinOrphan Designation:

Improvement of early renal allograft function following renal

transplantation.

Designation


Marketing Exclusivity Scios, Inc.

2450 Bayshore Parkway

Mountain View CA 94043

***************************************************************************************


Anatibant

Trade Name:

Orphan Designation:

Treatment of patients having experienced a severe traumatic brain

injury (Glasgow Coma Scale 3 to 8) in order to decrease early

Designation mortality and improve long-term functional and neurological

4/15/2005Sponsor and Addressoutcome

Marketing Exclusivity Xytis, Inc.

400 South El Camino Real

Suite 1200

San Mateo CA 94402-1703

***************************************************************************************


Ancrod

Trade Name:

ViprinexOrphan Designation:

To establish and maintain anticoagulation in heparin-intolerant

patients undergoing cardiopulmonary bypass.

Designation


Marketing Exclusivity Knoll Pharmaceutical Company

3000 Continental Dr., North

Mt. Olive NJ 07828

***************************************************************************************


Angiotensin 1-7

Trade Name:

MARstemOrphan Designation:

Treatment of myelodysplastic syndrome

Designation


Marketing Exclusivity Maret Pharmaceutical Corporation

4041 MacArthur Boulevard, Suite 375

Newport Beach CA 92660

***************************************************************************************


Angiotensin 1-7

Trade Name:

Orphan Designation:

Treatment of neutropenia associated with autologous bone marrow

transplantation.

Designation


Marketing Exclusivity Maret Pharmaceuticals

4041 MacArthur Blvd.

Suite 375

Newport Beach CA 92660

***************************************************************************************


Anti pan T lymphocyte monoclonal antibody

Trade Name:

Anti-t Lymphocyte Immunotoxin Xmmly-h65-rtaOrphan Designation:

For ex-vivo treatment to eliminate mature T cells from potential bone

marrow grafts.

Designation


Marketing Exclusivity Xoma Corporation

2910 Seventh Street

Berkeley CA 94710

****************************

Documents

€¦ · RTF file · 2007-04-10Marketing Exclusivity GenStar Therapeutics Corporation 10835 Altman Row Suite 150 San Diego CA 92121 ***** Generic Name Approved Orphan Indication: