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Serving leading biopharmaceutical companies globally:

Merck
Covington
Cerilliant
McKesson
Cantor Fitzgerald
US Army
Healthtrust
Citi
Chinese Patent Office
Julphar

Generated: December 12, 2017

DrugPatentWatch Database Preview

GABITRIL Drug Profile

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Which patents cover Gabitril, and what generic alternatives are available?

Gabitril is a drug marketed by Cephalon and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has twenty-five patent family members in twenty-one countries and two supplementary protection certificates in two countries.

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-005Apr 16, 1999ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-003Sep 30, 1997ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-007Nov 29, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-004Sep 30, 1997DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-001Sep 30, 1997ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-006Nov 29, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-002Sep 30, 1997ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-008Nov 29, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for GABITRIL

Drugname Dosage Strength RLD Submissiondate
tiagabine hydrochlorideTablets12 mg and 16 mgGabitril1/24/2014
tiagabine hydrochlorideTablets2 mg and 4 mgGabitril2/1/2005

International Patent Family for Tradename: GABITRIL

Country Document Number Estimated Expiration
Japan2000511909► Subscribe
Portugal906309► Subscribe
Hungary9904035► Subscribe
Argentina008236► Subscribe
Spain2181002► Subscribe
Russian Federation2177478► Subscribe
Norway316889► Subscribe
Brazil9709725► Subscribe
Australia3165397► Subscribe
Germany69715196► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: GABITRIL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0107Belgium► SubscribePRODUCT NAME: TIAGABINE CHLORHYDRATE MONOHYDRATE - TIAGABINE ANHYDRE; NAT. REGISTRATION NO/DATE: 403 IS 102 F 3 19970602; FIRST REGISTRATION: FR 341 260.2 19960614
C/GB98/022United Kingdom► SubscribePRODUCT 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
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Serving leading biopharmaceutical companies globally:

McKinsey
Cerilliant
Baxter
Covington
QuintilesIMS
Cantor Fitzgerald
Mallinckrodt
US Army
Daiichi Sankyo
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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