Nisoldipine Patent Expiration

Nisoldipine was first introduced by Covis Pharma Gmbh in its drug Sular on Feb 2, 1995. 3 different companies have introduced drugs containing Nisoldipine.


Nisoldipine Patents

Given below is the list of patents protecting Nisoldipine, 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
Sular US5626874 Controlled release pharmaceutical tablet having lenticular form Nov 30, 2014

(Expired)

Covis



Nisoldipine's Family Patents

Family Patents

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Nisoldipine Generic API Manufacturers

Several generic applications have been filed for Nisoldipine. The first generic version for Nisoldipine was by Mylan Pharmaceuticals Inc and was approved on Jul 25, 2008. And the latest generic version is by Amta Labs Ltd and was approved on Apr 10, 2023.

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


1. AMTA

Amta Labs Ltd has filed for 1 generic for Nisoldipine. Given below are the details of the strengths of this generic introduced by Amta.

Strength Dosage Form Availability Application Pathway TE code Launch Date
8.5MG

tablet, extended release Discontinued ORAL N/A Apr 10, 2023


Manufacturing Plant Locations
New

Amta's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Amta as present at those locations.

Country City Firm Name
United States
Raleigh Amtai Medical Equipment, INC





2. MYLAN

Mylan Pharmaceuticals Inc has filed for 7 different strengths of generic version for Nisoldipine. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG

(reference standard)

tablet, extended release Prescription ORAL N/A Jul 25, 2008
30MG

tablet, extended release Prescription ORAL N/A Jul 25, 2008
40MG

(reference standard)

tablet, extended release Prescription ORAL N/A Jul 25, 2008
8.5MG

tablet, extended release Prescription ORAL AB Jan 26, 2011
17MG

tablet, extended release Prescription ORAL AB Jan 26, 2011
25.5MG

tablet, extended release Prescription ORAL N/A Jan 26, 2011
34MG

tablet, extended release Prescription ORAL AB Jan 26, 2011


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
San Carlos Mylan Pharmaceuticals Inc.
Rockford Mylan Institutional, Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Morgantown Mylan Specialty, L.P.
Greensboro Mylan Pharmaceuticals Inc
Saint Albans Mylan Technologies, Inc.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
India
Sinnar Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Hosur Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta