Is there a generic for Tiagabine hydrochloride?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Tiagabine hydrochloride, referencing the brand GABITRIL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Tiagabine hydrochloride?

GABITRIL (NDA 020646, CEPHALON) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Tiagabine hydrochloride are approved?

Tiagabine hydrochloride is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Tiagabine hydrochloride

Tiagabine hydrochloride is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:GABITRIL · NDA 020646

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
GABITRILRLD×8	CEPHALON	NDA 020646	AB	Apr 16, 1999

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
TIAGABINE HYDROCHLORIDE×4	MSN	ANDA 214816	AB	Nov 16, 2021
TIAGABINE HYDROCHLORIDE×4	AMNEAL PHARMS CO	ANDA 208181	—	Dec 08, 2017
TIAGABINE HYDROCHLORIDE×4	WILSHIRE PHARMS INC	ANDA 206857	—	Oct 13, 2017
TIAGABINE HYDROCHLORIDE×2	SUN PHARM INDS	ANDA 077555	—	Nov 04, 2011

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Tiagabine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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