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Serving leading biopharmaceutical companies globally:

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Generated: December 18, 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, Sun Pharm Inds, and Wilshire Pharms Inc, and is included in three NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Pharmacology for 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 IndsTIAGABINE HYDROCHLORIDEtiagabine hydrochlorideTABLET;ORAL077555-002Nov 4, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-006Nov 29, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-007Nov 29, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Wilshire Pharms IncTIAGABINE HYDROCHLORIDEtiagabine hydrochlorideTABLET;ORAL206857-001Oct 13, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Wilshire Pharms IncTIAGABINE HYDROCHLORIDEtiagabine hydrochlorideTABLET;ORAL206857-002Oct 13, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm IndsTIAGABINE HYDROCHLORIDEtiagabine hydrochlorideTABLET;ORAL077555-001Nov 4, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-002Sep 30, 1997ABRXYesNo► Subscribe► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-001Sep 30, 1997ABRXYesYes► Subscribe► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-003Sep 30, 1997ABRXYesNo► Subscribe► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-008Nov 29, 2005DISCNNoNo► Subscribe► 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
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-002Sep 30, 1997► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-004Sep 30, 1997► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-003Sep 30, 1997► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-001Sep 30, 1997► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-002Sep 30, 1997► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-005Apr 16, 1999► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-004Sep 30, 1997► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-004Sep 30, 1997► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-003Sep 30, 1997► Subscribe► Subscribe
CephalonGABITRILtiagabine hydrochlorideTABLET;ORAL020646-004Sep 30, 1997► Subscribe► Subscribe
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International Patent Family for Ingredient: tiagabine hydrochloride

Country Document Number Estimated Expiration
Czech Republic295578► Subscribe
China1636565► Subscribe
World Intellectual Property Organization (WIPO)9747619► Subscribe
Spain2181002► Subscribe
South Korea20000016580► Subscribe
Denmark0906309► Subscribe
Germany69715196► Subscribe
Austria223405► Subscribe
Poland190858► Subscribe
Russian Federation2177478► 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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Serving leading biopharmaceutical companies globally:

UBS
Argus Health
Daiichi Sankyo
Fuji
McKesson
Accenture
Farmers Insurance
Chinese Patent Office
Boehringer Ingelheim
Federal Trade Commission

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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