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Carbamazepine - Generic Drug Details

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Carbamazepine is the generic ingredient in eight branded drugs marketed by Usl Pharma, Taro, Novartis, Validus Pharms Inc, Shire, Torrent Pharms, Wockhardt, Teva, Warner Chilcott, Lundbeck 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 four patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-eight patent family members in seventeen countries.

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

Summary for Generic Name: carbamazepine

Tradenames:8
Patents:4
Applicants:18
NDAs:29
Drug Master File Entries: see list27
Suppliers / Packaging: see list44
Therapeutic Class:Anticonvulsants
Bipolar Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Tentative approvals for CARBAMAZEPINE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL100MG
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL200MG
<disabled><disabled>CAPSULE, EXTENDED RELEASE; ORAL300MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Ireland Ltd
CARBAMAZEPINE
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL076697-001May 20, 2011RXNo► subscribe► subscribe
Validus Pharms Inc
EQUETRO
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL021710-001Dec 10, 2004RXNo6,977,253► subscribe ► subscribe
Taro
TERIL
carbamazepine
SUSPENSION;ORAL076729-001Sep 20, 2004RXNo► 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
Novartis
TEGRETOL-XR
carbamazepine
TABLET, EXTENDED RELEASE;ORAL020234-002Mar 25, 1996RE34990► subscribe
Novartis
TEGRETOL
carbamazepine
SUSPENSION;ORAL018927-001Dec 18, 19874,409,212► subscribe
Validus Pharms Inc
EQUETRO
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL021710-002Dec 10, 20045,326,570► 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
5,326,570 Advanced drug delivery system and method of treating psychiatric, neurological and other disorders with carbamazepine► subscribe
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
Denmark0660705► subscribe
China101959508► 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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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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