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Generated: April 27, 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 freedom to operate?

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

Carbamazepine has thirty-five patent family members in fourteen countries.

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

Summary for Generic Name: carbamazepine

Tradenames:8
Patents:5
Applicants:19
NDAs:29
Drug Master File Entries: see list27
Suppliers / Packagers: see list45
Bulk Api Vendors: see list91
Clinical Trials: see list38
Patent Applications: see list5,593
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. Form Dosage
► Subscribe► SubscribeCAPSULE, EXTENDED RELEASE; ORAL100MG
► Subscribe► SubscribeCAPSULE, EXTENDED RELEASE; ORAL200MG
► Subscribe► SubscribeCAPSULE, EXTENDED RELEASE; ORAL300MG
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Elizabeth
CARBAMAZEPINE
carbamazepine
TABLET;ORAL071696-001Nov 9, 1987DISCNNoNo► Subscribe► Subscribe
Novartis
TEGRETOL-XR
carbamazepine
TABLET, EXTENDED RELEASE;ORAL020234-002Mar 25, 1996ABRXYesNo► Subscribe► Subscribe
Mylan Ireland Ltd
CARBAMAZEPINE
carbamazepine
CAPSULE, EXTENDED RELEASE;ORAL076697-001May 20, 2011ABRXNoNo► Subscribe► Subscribe
Novartis
TEGRETOL
carbamazepine
TABLET, CHEWABLE;ORAL018281-001Approved Prior to Jan 1, 1982ABRXYesYes► Subscribe► Subscribe
Taro Pharm Inds
CARBAMAZEPINE
carbamazepine
TABLET, CHEWABLE;ORAL075687-002Jul 29, 2002RXNoYes► Subscribe► Subscribe
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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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