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GABITRIL Drug Profile

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Gabitril is a drug marketed by Cephalon and is included in one NDA. It is available from six suppliers. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-four patent family members in twenty-five 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.

Summary for Tradename: GABITRIL

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list6
Drug Prices: :see details

Pharmacology for Tradename: GABITRIL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-005Apr 16, 1999RXNo5,958,951► subscribe ► subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-008Nov 29, 2005DISCNNo► subscribe► subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-001Sep 30, 1997RXYes5,866,590► subscribe ► subscribe
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Expired Patents for Tradename: GABITRIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-005Apr 16, 19995,866,590► subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-005Apr 16, 19995,354,760► subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-002Sep 30, 19975,866,590► subscribe
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Paragraph IV activity 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
Spain2181002► subscribe
European Patent Office0906309► subscribe
Hungary9904035► 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
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
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
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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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