TIAGABINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for tiagabine hydrochloride and what is the scope of patent protection?

Tiagabine hydrochloride is the generic ingredient in two branded drugs marketed by Cephalon, Amneal Pharms Co, MSN, Sun Pharm Inds, and Wilshire Pharms Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for tiagabine hydrochloride. Six suppliers are listed for this compound.

Summary for TIAGABINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	20
Patent Applications:	1,258
Formulation / Manufacturing:	see details
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

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	208181-003	Dec 8, 2017		DISCN	No	No
Wilshire Pharms Inc	TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	206857-004	Oct 13, 2017		DISCN	No	No
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-008	Nov 29, 2005		DISCN	No	No
Amneal Pharms Co	TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	208181-004	Dec 8, 2017		DISCN	No	No
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-005	Apr 16, 1999	AB	RX	Yes	No
Sun Pharm Inds	TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	077555-001	Nov 4, 2011	AB	RX	No	No
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-006	Nov 29, 2005		DISCN	No	No

Expired US Patents for TIAGABINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-005	Apr 16, 1999
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-005	Apr 16, 1999
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-004	Sep 30, 1997
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-001	Sep 30, 1997
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-004	Sep 30, 1997
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-005	Apr 16, 1999
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-002	Sep 30, 1997