Alprostadil Patent Expiration

Alprostadil was first introduced by Pfizer Inc in its drug Prostin Vr Pediatric on Approved Prior to Jan 1, 1982. Other drugs containing Alprostadil are Edex, Caverject Impulse, Caverject, Muse. 5 different companies have introduced drugs containing Alprostadil.


Alprostadil Patents

Given below is the list of patents protecting Alprostadil, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Muse US5886039 Method and composition for treating erectile dysfunction Mar 23, 2016

(Expired)

Mylan Speciality Lp
Caverject US5741523 Stabilized prostaglandin E1 Apr 21, 2015

(Expired)

Pfizer
Caverject Impulse US5716338 Dual-chamber type injection cartridge with bypass connection Feb 10, 2015

(Expired)

Pfizer
Caverject Impulse US5501673 Injection cartridge Apr 16, 2013

(Expired)

Pfizer
Muse US5474535 Dosage and inserter for treatment of erectile dysfunction Dec 12, 2012

(Expired)

Mylan Speciality Lp



Alprostadil's Family Patents

Family Patents

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Alprostadil Generic API Manufacturers

Several generic applications have been filed for Alprostadil. The first generic version for Alprostadil was by Hikma Pharmaceuticals Usa Inc and was approved on Jan 20, 1998. And the latest generic version is by Meitheal Pharmaceuticals Inc and was approved on Apr 30, 1999.

Given below is the list of companies who have filed for Alprostadil generic, along with the locations of their manufacturing plants worldwide.


1. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Alprostadil. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG/ML

injectable Prescription INJECTION AP Jan 20, 1998


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Dayton Hikma Injectables USA Inc
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





2. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 1 generic for Alprostadil. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG/ML

injectable Prescription INJECTION AP Apr 30, 1999