Viewing data from:

GABITRIL

NDA

TIAGABINE HYDROCHLORIDE | N020646 | CEPHALON INC

8 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

7 trials from ClinicalTrials.gov, 1 active, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Treating Schizophrenia by Correcting Abnormal Brain Development NCT00179465	Phase 3	Active	Beth Israel Deaconess Medical Center	36	2003-11 → 2026-09
Effectiveness of Tiagabine for Cocaine Dependence in Methadone-Maintained Individuals - 1 NCT00129298	Phase 2	Completed	National Institute on Drug Abuse (NIDA)	80	2004-12 → 2007-04
Effectiveness of GABA Agonists in Reducing the Reinforcing Effects of Cocaine NCT00218166	Phase 2	Completed	National Institute on Drug Abuse (NIDA)	78	2001-08 → 2005-05
Characterization of [11C]Flumazenil to Image GABA Transmission in Healthy Adult Subjects and Subjects With Alcohol Dependence NCT01904487	Phase 1	Completed	Rajesh Narendran	11	2011-04-19 → 2013-10-01
Tiagabine to Enhance Slow Wave Sleep in Patients With Sleep Apnea NCT02387710	Phase 2	Completed	Brigham and Women's Hospital	18	2015-03 → 2016-07
A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice NCT00855738	Phase 4	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	111	2007-05 → 2009-06
Tiagabine for the Treatment of Cocaine Dependence - 1 NCT00086255	Phase 2	Completed	National Institute on Drug Abuse (NIDA)	140	2002-10 → 2004-06

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$6.02

per ea

Lowest NADAC/Unit

$2.06

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00093807256TIAGABINE HCL 12 MG TABLET	$6.02	EA	Generic	—	2026-05-20
00093503056TIAGABINE HCL 2 MG TABLET	$2.21	EA	Generic	—	2026-06-17
00093503156TIAGABINE HCL 4 MG TABLET	$2.06	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$26.18

Highest Price

$93.49

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00093-8072-56GABITRIL 12MG TAB	$71.19	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-8072-56GABITRIL 12MG TAB	$71.19	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-8076-56GABITRIL 16MG TAB	$93.49	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-8076-56GABITRIL 16MG TAB	$93.49	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-5030-56TIAGABINE HCL 2MG TAB	$26.18	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-5030-56TIAGABINE HCL 2MG TAB	$26.18	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-5031-56TIAGABINE HCL 4MG TAB	$26.18	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00093-5031-56TIAGABINE HCL 4MG TAB	$26.18	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain3 active DMFs3 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

SUN PHARMACEUTICAL INDUSTRIES LTDTIAGABINE HYDROCHLORIDE USP

DMF 179782005

CHEMWERTH INCTIAGABINE HYDROCHLORIDE

DMF 220332008

MSN LIFE SCIENCES PRIVATE LTDTIAGABINE HYDROCHLORIDE USP

DMF 334942018

RANBAXY LABORATORIES LTDInactiveTIAGABINE HYDROCHLORIDE USP

DMF 189342005

UNICHEM LABORATORIES LTDInactiveTIAGABINE HYDROCHLORIDE USP

DMF 272862013

SIGNA SA DE CVInactiveTIAGABINE HYDROCHLORIDE MONOHYDRATE USP

DMF 273802013

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Mar 6, 2023	SUPPL -23	View Letter (PDF)
Aug 9, 2016	SUPPL -21	View Letter (PDF)
Nov 9, 2015	SUPPL -18	View Letter (PDF)
Jan 30, 2012	SUPPL -20	View Letter (PDF)
Oct 13, 2010	SUPPL -17	View Letter (PDF)
May 4, 2009	SUPPL -16	View Letter (PDF)
Dec 6, 2005	SUPPL -15	View Letter (PDF)
Feb 17, 2005	SUPPL -14	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (8)

Sort:

#001 — 4MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 30, 1997

No patent or exclusivity listings for this strength.

#002 — 12MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 30, 1997

#003 — 16MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 30, 1997

#004 — 20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 30, 1997

#005 — 2MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 16, 1999

#006 — 6MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 29, 2005

#007 — 8MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 29, 2005

#008 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 29, 2005