Procos New Generic List_2014_V5_September 2014

PROCOS S.p.A. Via Matteotti n. 249 - 28062 CAMERI (NO) ITALY Phone: ++39-0321-642211 - Fax: ++39-0321-642219 E-mail: procos@procos.it www.procos.it

This list is not to be construed as a non-infringement or as an offer to sell in those countries where such would

constitute an infringement of third parties’ patent rights. September 2014

NEW PRODUCTS

VALIDATED

API CLASS/INDICATION DMF

Fampridine/Dalfampridine Treatment of some symptoms of Multiple Sclerosis EU: filed

US: available for reference

Guanfacine Antihypertensive and Treatment of ADHD EU: filed

US: filed

Iloperidone Antipsychotic EU: filed

US: available for reference

Landiolol Antiarrhythmic EU: filed

JP: filed

Lurasidone Antipsychotic EU: filed

US: in progress

Naftopidil Antihypertensive (Treatment of BPH) EU: filed

JP: filed

Ranolazine Antianginal EU: filed

US: in progress

Sivelestat Acute Respiratory Failure EU: filed

JP: filed

UNDER DEVELOPMENT

API CLASS/INDICATION DEVELOPMENT STATUS

Amifampridine Treatment of Lambert-Eaton syndrome (LEMS) LAB

Roflumilast Antiasthmatic (COPD) LAB

Silodosin Treatment of BPH KILOLAB

Agomelatine Antidepressant PILOT

Minodronic Acid Anti-osteoporosis INDUSTRIAL

UNDER EVALUATION

API CLASS/INDICATION STATUS

Alogliptin Antidiabetic Screening

Apixaban Antithrombotic Screening

Avanafil Erectyle disfunction Screening

Dapagliflozin Antidiabetic Screening

Dolutegravir HIV Screening

Droxidopa Neurogenic orthostatic hypotension Screening

Efinaconazole Onychomycosis

Screening

Levomilnacipran Major depressive disorder (MDD) Screening

Macitentan Pulmonary Arterial Hypertension (PAH) Screening

Miltefosine Leishmaniasis Screening

Perampanel Antiepileptic Screening Riociguat Pulmonary Arterial Hypertension (PAH) Screening

Simeprevir Hepatitis C Screening

Sofosbuvir Hepatitis C Screening

Vortioxetine Depressive Disorder Screening