Tiagabine Hydrochloride Patent Expiration

Tiagabine Hydrochloride was first introduced by Cephalon Inc in its drug Gabitril on Sep 30, 1997. 5 different companies have introduced drugs containing Tiagabine Hydrochloride.


Tiagabine Hydrochloride Patents

Given below is the list of patents protecting Tiagabine Hydrochloride, 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
Gabitril US5958951 Modified form of the R(-)-N-(4,4-di(3-methylthien-2-yl)but-3-enyl)-nipecotic acid hydrochloride Jun 10, 2017

(Expired)

Cephalon
Gabitril US5866590 Pharmaceutical composition containing tiagabine hydrochloride and the process for its preparation Apr 29, 2016

(Expired)

Cephalon



Tiagabine Hydrochloride's Family Patents

Family Patents

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Tiagabine Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Tiagabine Hydrochloride. The first generic version for Tiagabine Hydrochloride was by Sun Pharmaceutical Industries Ltd and was approved on Nov 4, 2011. And the latest generic version is by Msn Laboratories Private Ltd and was approved on Nov 16, 2021.

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


1. AMNEAL PHARMS CO

Amneal Pharmaceuticals Co Gmbh has filed for 4 different strengths of generic version for Tiagabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Amneal Pharms Co.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG

tablet Discontinued ORAL N/A Dec 8, 2017
4MG

tablet Discontinued ORAL N/A Dec 8, 2017
12MG

tablet Discontinued ORAL N/A Dec 8, 2017
16MG

tablet Discontinued ORAL N/A Dec 8, 2017





2. MSN

Msn Laboratories Private Ltd has filed for 4 different strengths of generic version for Tiagabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Msn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG

tablet Prescription ORAL AB Nov 16, 2021
4MG

tablet Prescription ORAL AB Nov 16, 2021
12MG

tablet Prescription ORAL AB Nov 16, 2021
16MG

tablet Prescription ORAL AB Nov 16, 2021


Manufacturing Plant Locations
New

Msn's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Msn as present at those locations.

Country City Firm Name
India
Kamareddy MSN Life Sciences Private Limited
Sangareddy MSN Pharmachem Private Limited
Rangareddy District MSN Laboratories Private Limited
Sangareddy MSN Laboratories Private Limited, R&D Center
Medak MSN LIFE SCIENCES PRIVATE LIMITED
Yadadri Bhuvanagiri District MSN Organics Private Limited
Rangareddy District MSN Laboratories Private Limited (Formulations Division, Unit-II)
Sangareddy MSN Laboratories Private Ltd.
Isnapur MSN Laboratories Private Limited, Unit-II
Jinnaram, Sangareddy MSN Laboratories Private Limited - Formulations Division
United States
Piscataway MSN PHARMACEUTICALS INC





3. SUN PHARM INDS

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Tiagabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG

tablet Prescription ORAL AB Nov 4, 2011
4MG

tablet Prescription ORAL AB Nov 4, 2011





4. WILSHIRE PHARMS INC

Wilshire Pharmaceuticals Inc has filed for 4 different strengths of generic version for Tiagabine Hydrochloride. Given below are the details of the strengths of this generic introduced by Wilshire Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG

tablet Discontinued ORAL N/A Oct 13, 2017
4MG

tablet Discontinued ORAL N/A Oct 13, 2017
12MG

tablet Discontinued ORAL N/A Oct 13, 2017
16MG

tablet Discontinued ORAL N/A Oct 13, 2017