TIAGABINE HYDROCHLORIDE Drug Patent Profile

When do Tiagabine Hydrochloride patents expire, and what generic alternatives are available?

Tiagabine Hydrochloride is a drug marketed by Amneal Pharms Co, MSN, Sun Pharm Inds, and Wilshire Pharms Inc. and is included in four NDAs.

The generic ingredient in TIAGABINE HYDROCHLORIDE is tiagabine hydrochloride. There are six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the tiagabine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tiagabine Hydrochloride

A generic version of TIAGABINE HYDROCHLORIDE was approved as tiagabine hydrochloride by SUN PHARM INDS on November 4^th, 2011.

Summary for TIAGABINE HYDROCHLORIDE

US Patents:	0
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	20
Patent Applications:	855
What excipients (inactive ingredients) are in TIAGABINE HYDROCHLORIDE?	TIAGABINE HYDROCHLORIDE excipients list
DailyMed Link:	TIAGABINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for TIAGABINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Assiut University	Phase 4
Mid-Atlantic Epilepsy and Sleep Center, LLC	Phase 4
Eisai Inc.	Phase 4

See all TIAGABINE HYDROCHLORIDE clinical trials

Pharmacology for TIAGABINE HYDROCHLORIDE

Drug Class	Anti-epileptic Agent
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for TIAGABINE HYDROCHLORIDE

N03AG	Fatty acid derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for TIAGABINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GABITRIL	Tablets	tiagabine hydrochloride	12 mg and 16 mg	020646	1	2014-01-24
GABITRIL	Tablets	tiagabine hydrochloride	2 mg and 4 mg	020646	1	2005-02-01

US Patents and Regulatory Information for TIAGABINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Co	TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	208181-001	Dec 8, 2017		DISCN	No	No
Msn	TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	214816-003	Nov 16, 2021	AB	RX	No	No
Amneal Pharms Co	TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	208181-004	Dec 8, 2017		DISCN	No	No
Wilshire Pharms Inc	TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	206857-002	Oct 13, 2017		DISCN	No	No
Msn	TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	214816-004	Nov 16, 2021	AB	RX	No	No
Wilshire Pharms Inc	TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	206857-004	Oct 13, 2017		DISCN	No	No
Amneal Pharms Co	TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	208181-002	Dec 8, 2017		DISCN	No	No