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Last Updated: July 30, 2021

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CARBAMAZEPINE Drug Patent Profile


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When do Carbamazepine patents expire, and when can generic versions of Carbamazepine launch?

Carbamazepine is a drug marketed by Apotex Inc, Nostrum Labs Inc, Taro, Teva Pharms, Wockhardt Bio Ag, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Cspc Ouyi, Unique Pharm, Zydus Pharms, Actavis Elizabeth, Inwood Labs, Pliva, Umedica Labs Pvt Ltd, Usl Pharma, and Warner Chilcott. and is included in twenty-two NDAs.

The generic ingredient in CARBAMAZEPINE is carbamazepine. There are twenty-seven drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Carbamazepine

A generic version of CARBAMAZEPINE was approved as carbamazepine by TARO on October 3rd, 1996.

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Paragraph IV (Patent) Challenges for CARBAMAZEPINE
Tradename Dosage Ingredient NDA Submissiondate
EQUETRO CAPSULE, EXTENDED RELEASE;ORAL carbamazepine 021710 2014-05-23
EQUETRO CAPSULE, EXTENDED RELEASE;ORAL carbamazepine 021710 2007-08-21
CARBATROL CAPSULE, EXTENDED RELEASE;ORAL carbamazepine 020712 2006-02-02
TEGRETOL-XR TABLET, EXTENDED RELEASE;ORAL carbamazepine 020234 2005-12-30

US Patents and Regulatory Information for CARBAMAZEPINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Umedica Labs Pvt Ltd CARBAMAZEPINE carbamazepine TABLET;ORAL 207798-002 Apr 15, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Apotex Inc CARBAMAZEPINE carbamazepine TABLET;ORAL 075948-001 Feb 27, 2002 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Zydus Pharms CARBAMAZEPINE carbamazepine TABLET, EXTENDED RELEASE;ORAL 205571-001 Feb 7, 2019 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
Dow
McKesson
AstraZeneca
Colorcon

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