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Last Updated: April 16, 2024

TIAGABINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for tiagabine hydrochloride and what is the scope of freedom to operate?

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
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

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
Wilshire Pharms Inc	TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	206857-001	Oct 13, 2017		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Msn	TIAGABINE HYDROCHLORIDE	tiagabine hydrochloride	TABLET;ORAL	214816-001	Nov 16, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-001	Sep 30, 1997	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-007	Nov 29, 2005		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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	020646-005	Apr 16, 1999	⤷ Try a Trial	⤷ Try a Trial
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-005	Apr 16, 1999	⤷ Try a Trial	⤷ Try a Trial
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-004	Sep 30, 1997	⤷ Try a Trial	⤷ Try a Trial
Cephalon	GABITRIL	tiagabine hydrochloride	TABLET;ORAL	020646-001	Sep 30, 1997	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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