TIAGABINE HYDROCHLORIDE - Generic Drug Details

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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. Five 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:	5
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	20
Patent Applications:	1,258
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
Eisai Inc.	Phase 4
Mid-Atlantic Epilepsy and Sleep Center, LLC	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

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Glossary

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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	208181-002	Dec 8, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms Co	TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	208181-001	Dec 8, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-002	Sep 30, 1997	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-004	Sep 30, 1997		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for TIAGABINE HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-003	Sep 30, 1997	⤷ Sign Up	⤷ Sign Up
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-003	Sep 30, 1997	⤷ Sign Up	⤷ Sign Up
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-002	Sep 30, 1997	⤷ Sign Up	⤷ Sign Up
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-005	Apr 16, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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