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Para 4 Patent Certified ANDAs in 2010

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Page 1: Para 4 Patent Certified ANDAs in 2010

No. DRUG NAME BRAND NAME NDA APPLICANT RELATED PATENTS

1 HEPSERA GILEAD 5663159, 6451340

2 REYATAZ 5849911, 6087383

3 GLAXOSMITHKLINE

4 Bimatoprost LATISSE ALLERGAN

5 Budesonide ASTRAZENECA

6 TACLONEX LEO PHARM

7 Clarithromycin BIAXIN XL ABBOTT 6010718, 6551616

8 OLUX E STIEFEL LABS INC 6730288, 7029659

9 WELCHOL DAIICHI SANKYO

10 PREZISTA TIBOTEC

PATENT EXPIRY DATE

Adefovir Dipivoxil Sept 2, 2014, Jul 23, 2018

Atazanavir Sulfate

BRISTOL MYERS SQUIBB

June 20, 2017, Dec 21, 2018

Atovaquone and Proguanil Hydrochloride

MALARONE PEDIATRIC

5998449, 6166046, 6291488

Nov 25, 2013 , Nov 25, 2013 , Nov 25, 2013

6403649, 7351404, 7388029

Sept 21, 2012, May 25, 2024 , Jan 21, 2022

PULMICORT RESPULES

6598603, 6899099, 7524834

Dec 23, 2018 , Dec 23, 2018 , Nov 11, 2018

Calcipotriene and Betamethasone Dipropionate

5763426, 6753013, 6753013, RE39706

Jun 9, 2015 , Jan 27, 2020 , Jan 27, 2020 , Jun 9, 2015

Apr 11, 2017 , Jul 15, 2017

Clobetasol Propionate

Sep 8, 2019, Sep 8, 2019

Colesevelam Hydrochloride

5607669, 5679717, 5693675, 5917007, 5919832, 6066678, 6433026, 6784254, 7101960, 7229613,

Jun 10, 2014, Apr 29, 2014 , Dec 2, 2014, Apr 29, 2014, Apr 29, 2014 , Apr 29, 2014 ,Apr 29, 2014 , Apr 29, 2014 , Apr 29, 2014, Apr 17, 2022

Darunavir Ethanolate

5843946 , 5843946 , 5843946 , 6037157 , 6248775 , 6335460 , 6335460 , 6335460 , 6703403 , 7470506 , 7700645

Dec 1, 2015 , Dec 1, 2015 , Dec 1, 2015 , Jun 26, 2016 , Aug 13, 2014 , Aug 25, 2012 , Aug 25, 2012 , Aug 25, 2012 , Jun 26, 2016 , Jun 23, 2019 , Dec 26, 2026

Page 2: Para 4 Patent Certified ANDAs in 2010

11 Dasatinib SPRYCEL

12 Dexlansoprazole DEXILANT TAKEDA PHARMS

13 FOCALIN XR NOVARTIS

14 ARICEPT ODT EISAI INC

15 SILENOR SOMAXON

16 Doxercalciferol HECTOROL GENZYME 5602116, 6903083

17 JALYN GLAXOSMITHKLINE

BRISTOL MYERS SQUIBB

6596746, 6596746, 7125875, 7125875, 7153856, 7491725

Jun 28, 2020, Jun 28, 2020, Apr 13, 2020, Apr 13, 2020, Apr 28, 2020, Mar 28, 2026

6462058, 6462058, 6462058, 6664276, 6664276, 6664276, 6939971, 6939971, 6939971, 7285668, 7790755

Jun 15, 2020, Jun 15, 2020, Jun 15, 2020, Jun 15, 2020 , Jun 15, 2020, Jun 15, 2020, Jun 15, 2020, Jun 15, 2020 , Jun 15, 2020, Jun 15, 2020, Aug 2, 2026,

Dexmethylphenidate Hydrochloride

5837284, 5908850, 6228398, 6355656, 6528530, 6635284, 6730325, 7431944

Dec 4, 2015, Dec 4, 2015, Nov 1, 2019, Dec 4, 2015, Dec 4, 2015, Dec 4, 2015, Nov 1, 2019, Dec 4, 2015

Donepezil Hydrochloride

4895841, 7727548, 7727552

Nov 25, 2010, Jun 23, 2022, Mar 26, 2018

Doxepin Hydrochloride

5502047, 5585115, 5725884, 5866166, 5948438, 6103219, 6211229, 6217909

Mar 26, 2013 , Jan 9, 2015 , Jan 9, 2015 , Jan 9, 2015 , Jan 9, 2015 , Jan 9, 2015 , Feb 17, 2020 , Jan 9, 2015

Feb 11, 2014, Jul 18, 2021

Dutasteride and Tamsulosin Hydrochloride

5565467, 5846976 , 5998427

Nov 20, 2015 , Sep 17, 2013 , Sep 17, 2013

Page 3: Para 4 Patent Certified ANDAs in 2010

18 RELPAX PFIZER IRELAND 5545644, 6110940

19 Entecavir BARACLUDE 5206244 Feb 21, 2015

20 TEVETEN ABBOTT 5656650 Aug 12, 2014

21 Estradiol NOVARTIS

22 NATAZIA BAYER HLTHCARE

23 Fenofibrate FENOGLIDE SHIONOGI PHARMA 7658944 Dec 9, 2024

24 ALLEGRA SANOFI AVENTIS US

Eletriptan Hydrobromide

Dec 26, 2016, Aug 29, 2017

BRISTOL MYERS SQUIBB

Eprosartan Mesylate

VIVELLE-DOT5474783, 5656286, 5958446, 6024976

Dec 12, 2012, Aug 12, 2014, Dec 12, 2012, Jan 7, 2014

Estradiol Valerate and Dienogest

6133251, 6133251, 6133251, 6884793

Oct 25, 2016, Oct 25, 2016, Oct 25, 2016, Oct 25, 2016

Fexofenadine Hydrochloride

5578610, 6037353, 6187791, 6399632, 7138524

Nov 26, 2013, Mar 14, 2010, May 11, 2012, May 11, 2012, May 18, 2014, Nov 18, 2014

Page 4: Para 4 Patent Certified ANDAs in 2010

25 Gatifloxacin ZYMAXID ALLERGAN 5880283, 6333045,

26 TRIAX PHARMS LLC 5635497 Jun 3, 2014

27 EXALGO MALLINCKRODT INC 5702725, 5914131

28 Ibupofen Lysine NEOPROFEN LUNDBECK INC 6342530, 6344479

29 Lenalidomide REVLIMID CELGENE

30 METHYLIN MALLINCKRODT 7691880 Oct 07, 2024

31 METOZOLV ODT SALIX PHARMS 6413549 Jul 11, 2017

Dec 5, 2015, Aug 20, 2019

Hydrocortisone Butyrate

LOCOID LIPOCREAM

Hydromorphone Hydrochloride

Jul 7 , 2014, Jul 7 , 2014

Nov 14, 2020, Mar 20, 2021

5635517, 6045501, 6281230, 6315720 , 6555554, 6561976, 6561977, 6755784 , 6908432, 7119106, 7189740, 7465800, 7855217

Oct 4, 2019, Aug 28, 2018, Jul 24, 2016, Oct 23, 2020, Jul 24, 2016, Aug 28, 2018, Oct 23, 2020, Oct 23, 2020, Aug 28, 2018, Jul 24, 2016, Apr 11, 2023, Apr 22, 2026, Nov 24, 2024

Methylphenidate Hydrochloride

Metoclopramide Hydrochloride

Page 5: Para 4 Patent Certified ANDAs in 2010

32 SOLODYN MEDICIS 5908838, 7790705

33 VIMOVO ASTRAZENECA LP

34 SIMCOR ABBOTT

35 Zegerid OTC SCHERING PLOUGH

36 TAMIFLU ROCHE

37 OXYCONTIN PURDUE PHARMA LP

38 MIRAPEX ER 4886812, 7695734

Minocycline Hydrochloride

Feb 19, 2018, Nov 20, 2025

Naproxen and Esomeprazole Magnesium

5714504, 5900424, 6369085, 6875872, 6926907, 7411070, 7745466

Feb 3, 2015 , May 4, 2016, May 25, 2018, May 27, 2014, Feb 28, 2023, May 25, 2018 , Oct 13, 2018

Niacin and Simvastatin

6080428, 6129930, 6406715, 6469035, 6676967, 6746691, 6818229, 7011848

May 27, 2017, Sep 20, 2013, Sep 20, 2013, Mar 15, 2018, Sep 20, 2013, Sep 20, 2013 , Sep 20, 2013, Sep 20, 2013

Omeprazole and Sodium Bicarbonate

6489346, 6645988, 6699885, 7399772

Jul 15 , 2016, Jul 15 , 2016, Jul 15 , 2016, Jul 15 , 2016

Oseltamivir Phosphate

5763483, 5866601, 5952375,

Dec 27, 2016 , Feb 2, 2016 , Feb 2, 2016

Oxycodone Hydrochloride

5508042, 6488963, 7674799, 7674800, 7683072, 7776314

Apr 16, 2013, Jun 24, 2017, Mar 30, 2025, Mar 30, 2025, Mar 30, 2025, Apr 19, 2025

Pramipexole Dihydrochloride

BOEHRINGER INGELHEIM

Oct 8, 2010, Apr 26, 2028

Page 6: Para 4 Patent Certified ANDAs in 2010

39 ORAPRED ODT SHIONOGI PHARMA

40 Pregablin LYRICA PFIZER

41 Ranolazine RANEXA GILEAD

42 AZILECT TEVA

43 Sirolimus RAPAMUNE WYETH PHARMS INC

44 BRAINTREE LABS 6946149 Apr, 30, 2022

45 Sodium Oxybate XYREM JAZZ

Prednisolone Sodium Phosphate

6024981, 6221392, 6740341

Apr 9, 2018, Apr 9, 2018, Nov 24, 2019

5563175, 6001876, 6001876, 6197819, RE41920

Oct 8, 2013, Dec 30, 2018, Dec 30, 2018, Dec 30, 2018, Dec 30, 2018

6303607, 6369062, 6479496, 6503911, 6525057, 6562826, 6617328, 6620814, 6852724, 6864258

May 27, 2019, May 27, 2019, May 27, 2019, May 27, 2019, May 27, 2019, May 27, 2019, May 27, 2019, May 27, 2019, May 27, 2019, May 27, 2019

Rasagiline Mesylate

5387612, 5453446, 5457133, 5532415, 5786390, 6126968, 7572834, 7815942

Feb 7 , 2012, Feb 7 , 2017, Feb 7 , 2012, Jul 2 , 2013, Feb 7 , 2012, Sep 18 , 2016, Dec 5 , 2026, Aug 27 , 2027

5100899, 5145684, 5403833, 5989591

Jul 7, 2013, Jan 25 , 2011, Apr 4 , 2012, Mar 11 , 2018

Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate

SUPREP BOWEL PREP KIT

6780889, 7262219, 7668730, 7765106, 7765107, 7851506, 7851506, 7895059

Jul 4, 2020, Jul 4, 2020, Mar 7, 2024 , Jun 16, 2024 , Jun 16, 2024, Dec 22, 2019, Dec 22, 2019, Dec 17, 2022

Page 7: Para 4 Patent Certified ANDAs in 2010

46 JANUVIA MERCK CO INC

47 JANUMET MERCK

48 Sunitinib Malate SUTENT CPPI CV

49 Tacrolimus PROTOPIC ASTELLAS 5385907, 5665727

50 VIREAD GILEAD

Sitagliptin Phosphate

6303661, 6699871, 6890898, 6890898, 6890898, 7078381, 7078381, 7078381, 7078381, 7125873, 7125873, 7125873, 7125873, 7326708

Apr 24 , 2017, Jul 26 , 2022, Feb 2 , 2019, Feb 2 , 2019, Feb 2 , 2019, Feb 2 , 2019, Feb 2 , 2019, Feb 2 , 2019, Feb 2 , 2019, Jul 26 , 2022, Jul 26 , 2022, Jul 26 , 2022, Jul 26 , 2022, Apr 11, 2026

Sitagliptin Phosphate and Metformin Hydrochloride

6303661, 6699871, 6890898, 6890898, 6890898, 7078381, 7078381, 7078381, 7125873, 7125873, 7125873, 7326708

Apr 24 , 2017, Jul 26 , 2022, Feb 2 , 2019, Feb 2 , 2019, Feb 2 , 2019, Feb 2 , 2019, Feb 2 , 2019, Feb 2 , 2019, Jul 26 , 2022, Jul 26 , 2022, Jul 26 , 2022, Apr 11 , 2026

6573293, 7125905, 7211600

Feb 15, 2021, Feb 15, 2021, Dec 22, 2020

Jan 31, 2012, Sep 9, 2014

Tenofovir Disoproxil Fumarate

5922695, 5922695, 5922695, 5922695, 5935946, 5935946, 5935946, 5935946, 5977089, 5977089, 5977089, 5977089, 6043230, 6043230, 6043230, 6043230

Jul 25 , 2017, Jul 25 , 2017, Jul 25 , 2017, Jul 25 , 2017, Jul 25 , 2017, Jul 25 , 2017, Jul 25 , 2017, Jul 25 , 2017, Jul 25 , 2017, Jul 25 , 2017, Jul 25 , 2017, Jul 25 , 2017, Jul 25 , 2017, Jul 25, 2017, Jul 25 , 2017, Jul 25 , 2017

Page 8: Para 4 Patent Certified ANDAs in 2010

51 OLEPTRO LABOPHARM 6607748, 7829120

52 Tretinoin RETIN-A MICRO 5955109 Sept 21, 2016

53 CHANTIX PFIZER INC

54 Voriconazole VFEND PFIZER

55 EDLUAR MEDA PHARMS 6761910 Sept 24, 2019

Brain League IP Services - SiNApSE Blog

Trazodone Hydrochloride

Jun 29, 2020, Mar 27, 2027

ORTHO DERMATOLOGICS

Varenicline Tartrate

6410550, 6890927, 7265119

May 10, 2020, May 6, 2022, Aug 3, 2022

5364938, 5567817, 5773443

Nov 15, 2011, May 24, 2016, Jan 25, 2011

Zolpidem Tartrate