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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Colorcon
Cerilliant
Boehringer Ingelheim
Cantor Fitzgerald
Medtronic
Julphar
Johnson and Johnson
McKinsey
Accenture

Generated: December 12, 2017

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Carbamazepine - Generic Drug Details

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What are the generic sources for carbamazepine and what is the scope of carbamazepine freedom to operate?

Carbamazepine
is the generic ingredient in eight branded drugs marketed by Apotex Inc, Mylan Ireland Ltd, Taro, Teva Pharms, Shire, Validus Pharms, Lundbeck Pharms Llc, Wockhardt, Novartis, Taro Pharm, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Teva, Actavis Elizabeth, Inwood Labs, Pliva, Usl Pharma, and Warner Chilcott, and is included in twenty-nine NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carbamazepine has fifty-eight patent family members in nineteen countries.

There are twenty-seven drug master file entries for carbamazepine. Forty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Medical Subject Heading (MeSH) Categories for carbamazepine

Tentative approvals for CARBAMAZEPINE

Applicant Application No. Strength Dosage Form
u► Subscribe100MGCAPSULE, EXTENDED RELEASE; ORAL
u► Subscribe300MGCAPSULE, EXTENDED RELEASE; ORAL
u► Subscribe200MGCAPSULE, EXTENDED RELEASE; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Torrent PharmsCARBAMAZEPINEcarbamazepineTABLET;ORAL077272-003Dec 7, 2005RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Ireland LtdCARBAMAZEPINEcarbamazepineCAPSULE, EXTENDED RELEASE;ORAL076697-003May 20, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Lundbeck Pharms LlcCARNEXIVcarbamazepineSOLUTION;IV (INFUSION)206030-001Oct 7, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Inwood LabsCARBAMAZEPINEcarbamazepineTABLET;ORAL070231-001Aug 14, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
TevaEPITOLcarbamazepineTABLET;ORAL070541-001Sep 17, 1986ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Taro Pharm IndsCARBAMAZEPINEcarbamazepineTABLET, CHEWABLE;ORAL075687-002Jul 29, 2002RXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Apotex IncCARBAMAZEPINEcarbamazepineCAPSULE, EXTENDED RELEASE;ORAL078986-002Nov 25, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis ElizabethCARBAMAZEPINEcarbamazepineTABLET;ORAL071696-001Nov 9, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
TaroCARBAMAZEPINEcarbamazepineSUSPENSION;ORAL075875-001Dec 21, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
TaroCARBAMAZEPINEcarbamazepineTABLET;ORAL074649-001Oct 3, 1996ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: carbamazepine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
NovartisTEGRETOL-XRcarbamazepineTABLET, EXTENDED RELEASE;ORAL020234-003Mar 25, 1996► Subscribe► Subscribe
NovartisTEGRETOL-XRcarbamazepineTABLET, EXTENDED RELEASE;ORAL020234-002Mar 25, 1996► Subscribe► Subscribe
Validus PharmsEQUETROcarbamazepineCAPSULE, EXTENDED RELEASE;ORAL021710-001Dec 10, 2004► Subscribe► Subscribe
NovartisTEGRETOLcarbamazepineTABLET;ORAL016608-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
NovartisTEGRETOL-XRcarbamazepineTABLET, EXTENDED RELEASE;ORAL020234-001Mar 25, 1996► Subscribe► Subscribe
Validus PharmsEQUETROcarbamazepineCAPSULE, EXTENDED RELEASE;ORAL021710-003Dec 10, 2004► Subscribe► Subscribe
ShireCARBATROLcarbamazepineCAPSULE, EXTENDED RELEASE;ORAL020712-003Sep 30, 1997► Subscribe► Subscribe
Validus PharmsEQUETROcarbamazepineCAPSULE, EXTENDED RELEASE;ORAL021710-001Dec 10, 2004► Subscribe► Subscribe
NovartisTEGRETOL-XRcarbamazepineTABLET, EXTENDED RELEASE;ORAL020234-002Mar 25, 1996► Subscribe► Subscribe
NovartisTEGRETOLcarbamazepineSUSPENSION;ORAL018927-001Dec 18, 1987► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: carbamazepine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,200,088Sulfoalkyl ether cyclodextrin compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: carbamazepine

Country Document Number Estimated Expiration
Russian Federation2455996► Subscribe
Canada2702603► Subscribe
South Korea101314803► Subscribe
Canada2624463► Subscribe
Australia2013226073► Subscribe
Russian Federation2012112839► Subscribe
Cyprus1115517► Subscribe
China101959508► Subscribe
World Intellectual Property Organization (WIPO)2009134347► Subscribe
Australia2009241858► 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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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Harvard Business School
McKesson
Federal Trade Commission
Novartis
US Army
Boehringer Ingelheim
Argus Health
US Department of Justice
Dow

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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