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Last Updated: March 28, 2024

Gabitril Drug Patent Profile


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Which patents cover Gabitril, and when can generic versions of Gabitril launch?

Gabitril is a drug marketed by Cephalon and is included in one NDA.

The generic ingredient in GABITRIL is tiagabine hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tiagabine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Gabitril

A generic version of Gabitril was approved as tiagabine hydrochloride by SUN PHARM INDS on November 4th, 2011.

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Drug patent expirations by year for Gabitril
Drug Prices for Gabitril

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Recent Clinical Trials for Gabitril

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Brigham and Women's HospitalPhase 2
Rajesh NarendranPhase 1
CephalonPhase 3

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Pharmacology for Gabitril
Anatomical Therapeutic Chemical (ATC) Classes for Gabitril
Paragraph IV (Patent) Challenges for GABITRIL
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 Gabitril

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-005 Apr 16, 1999 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-003 Sep 30, 1997 AB RX Yes No ⤷  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
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-004 Sep 30, 1997 DISCN 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 020646-006 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 Gabitril

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-003 Sep 30, 1997 ⤷  Try a Trial ⤷  Try a Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-002 Sep 30, 1997 ⤷  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 020646-002 Sep 30, 1997 ⤷  Try a Trial ⤷  Try a Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-003 Sep 30, 1997 ⤷  Try a Trial ⤷  Try a Trial
Cephalon GABITRIL tiagabine hydrochloride TABLET;ORAL 020646-004 Sep 30, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for Gabitril

See the table below for patents covering Gabitril around the world.

Country Patent Number Title Estimated Expiration
Austria 223405 ⤷  Try a Trial
South Korea 100440354 ⤷  Try a Trial
Norway 870781 ⤷  Try a Trial
Argentina 008236 FORMA CRISTALINA ANHIDRA DEL CLORHIDRATO DE ACIDO R(-)-N-(4,4-DI(3- METILTIEN-2-IL)BUT-3-ENIL)-NIPECOTICO, UNA COMPOSICION FARMACEUTICA Y EL USO DE DICHA SAL CRISTALINA PARA LA PREPARACION DE UNA COMPOSICION FARMACEUTICA ⤷  Try a Trial
Israel 118142 ⤷  Try a Trial
Norway 933524 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for Gabitril

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0236342 97C0107 Belgium ⤷  Try a Trial PRODUCT NAME: TIAGABINE CHLORHYDRATE MONOHYDRATE - TIAGABINE ANHYDRE; NAT. REGISTRATION NO/DATE: 403 IS 102 F 3 19970602; FIRST REGISTRATION: FR 341 260.2 19960614
0236342 SPC/GB98/022 United Kingdom ⤷  Try a Trial PRODUCT NAME: TIAGABINE ( INCLUDING SALTS THEREOF ); REGISTERED: FR AMM NO. 341 260.2 19960614; FR AMM NO. 341 262.5 19960614; FR AMM NO. 341 264.8 19960614; UK 03132/0117 19971111; UK 03132/0118 19971111; UK 03132/0119 19971111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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