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Serving leading biopharmaceutical companies globally:

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Moodys
McKinsey
AstraZeneca
Deloitte
Dow
Accenture
Argus Health
Merck
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Generated: October 17, 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 Usl Pharma, Taro, Novartis, Validus Pharms, Shire, Torrent Pharms, Wockhardt, Teva, Taro Pharm, Warner Chilcott, Lundbeck Pharms Llc, Inwood Labs, Jubilant Cadista, Apotex Inc, Pliva, Taro Pharm Inds, Teva Pharms, Actavis Elizabeth, and Mylan Ireland Ltd, and is included in twenty-nine NDAs. There are six 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-three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: carbamazepine

US Patents:6
Tradenames:8
Applicants:19
NDAs:29
Drug Master File Entries: see list27
Suppliers / Packagers: see list43
Bulk Api Vendors: see list99
Clinical Trials: see list132
Patent Applications: see list6,568
Therapeutic Class:Bipolar Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:carbamazepine at DailyMed

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 Product Substance Delist Req. Exclusivity Expiration
Wockhardt
CARBAMAZEPINE
carbamazepine
SUSPENSION;ORAL075714-001Jun 5, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
Taro
CARBAMAZEPINE
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL201106-002Jun 21, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis
TEGRETOL
carbamazepine
SUSPENSION;ORAL018927-001Dec 18, 1987ABRXYesYes► Subscribe► Subscribe► Subscribe
Pliva
CARBAMAZEPINE
carbamazepine
TABLET;ORAL071479-001Jul 24, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Torrent Pharms
CARBAMAZEPINE
carbamazepine
TABLET;ORAL077272-004Dec 7, 2005RXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
CARBAMAZEPINE
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL078592-003Sep 20, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Taro
CARBAMAZEPINE
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL201106-001Jun 21, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
CARBAMAZEPINE
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL078986-002Nov 25, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Validus Pharms
EQUETRO
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL021710-002Dec 10, 2004RXYesNo► Subscribe► Subscribe ► Subscribe
Lundbeck Pharms Llc
CARNEXIV
carbamazepine
SOLUTION;IV (INFUSION)206030-001Oct 7, 2016RXYesYes► Subscribe► SubscribeY ► 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
Validus Pharms
EQUETRO
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL021710-002Dec 10, 2004► Subscribe► Subscribe
Novartis
TEGRETOL-XR
carbamazepine
TABLET, EXTENDED RELEASE;ORAL020234-002Mar 25, 1996► Subscribe► Subscribe
Novartis
TEGRETOL-XR
carbamazepine
TABLET, EXTENDED RELEASE;ORAL020234-001Mar 25, 1996► Subscribe► Subscribe
Shire
CARBATROL
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL020712-002Sep 30, 1997► Subscribe► Subscribe
Novartis
TEGRETOL-XR
carbamazepine
TABLET, EXTENDED RELEASE;ORAL020234-003Mar 25, 1996► Subscribe► Subscribe
Novartis
TEGRETOL
carbamazepine
TABLET;ORAL016608-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Shire
CARBATROL
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL020712-003Sep 30, 1997► Subscribe► Subscribe
Novartis
TEGRETOL-XR
carbamazepine
TABLET, EXTENDED RELEASE;ORAL020234-003Mar 25, 1996► Subscribe► Subscribe
Novartis
TEGRETOL
carbamazepine
SUSPENSION;ORAL018927-001Dec 18, 1987► Subscribe► Subscribe
Shire
CARBATROL
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL020712-003Sep 30, 1997► 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
9,750,822Sulfoalkyl 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
European Patent Office2748205► Subscribe
European Patent Office2444090► Subscribe
Australia2009241858► Subscribe
Japan2016166368► Subscribe
Japan2015110671► Subscribe
Japan5284096► Subscribe
World Intellectual Property Organization (WIPO)2013130666► Subscribe
Australia2006299501► Subscribe
Japan2015508846► Subscribe
South Korea20110010742► 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
Accenture
Federal Trade Commission
Harvard Business School
UBS
Cipla
Novartis
Deloitte
McKinsey
Queensland Health

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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