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Serving 500+ biopharmaceutical companies globally:

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Generated: June 25, 2017

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Tiagabine hydrochloride - Generic Drug Details

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What are the generic sources for tiagabine hydrochloride and what is the scope of tiagabine hydrochloride patent protection?

Tiagabine hydrochloride
is the generic ingredient in two branded drugs marketed by Cephalon and Sun Pharm Inds, and is included in two NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tiagabine hydrochloride has twenty-four patent family members in twenty-one countries.

There are five drug master file entries for tiagabine hydrochloride. Eight suppliers are listed for this compound.

Summary for Generic Name: tiagabine hydrochloride

Tradenames:2
Patents:2
Applicants:2
NDAs:2
Drug Master File Entries: see list5
Suppliers / Packagers: see list8
Bulk Api Vendors: see list35
Clinical Trials: see list2,262
Patent Applications: see list500
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:tiagabine hydrochloride at DailyMed

Pharmacology for Ingredient: tiagabine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds
TIAGABINE HYDROCHLORIDE
tiagabine hydrochloride
TABLET;ORAL077555-001Nov 4, 2011ABRXNoNo► Subscribe► Subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-003Sep 30, 1997RXYesNo5,958,951► Subscribe ► Subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-001Sep 30, 1997ABRXYesYes5,958,951► Subscribe ► Subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-008Nov 29, 2005DISCNNoNo► Subscribe► Subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-004Sep 30, 1997DISCNNoNo5,958,951► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: tiagabine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-005Apr 16, 19995,958,951► Subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-003Sep 30, 19975,866,590► Subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-001Sep 30, 19975,354,760► Subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-001Sep 30, 19975,866,590► Subscribe
Cephalon
GABITRIL
tiagabine hydrochloride
TABLET;ORAL020646-005Apr 16, 19995,010,090► Subscribe
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International Patent Family for Ingredient: tiagabine hydrochloride

Country Document Number Estimated Expiration
Germany69715196► Subscribe
Czech Republic295578► Subscribe
Austria223405► Subscribe
Poland190858► 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: TIAGABINE HYDROCHLORIDE

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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cipla
Boehringer Ingelheim
AstraZeneca
Deloitte
Harvard Business School
McKinsey
Mallinckrodt
Teva
Farmers Insurance
Chinese Patent Office

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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