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Last Updated: October 4, 2024

CARBAMAZEPINE - Generic Drug Details


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

Carbamazepine is the generic ingredient in eight branded drugs marketed by Apotex Inc, Nostrum Labs Inc, Taro, Teva Pharms, Takeda Pharms Usa, Validus Pharms, Lundbeck Pharms Llc, Chartwell Rx, Novitium Pharma, Novartis, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Teva, Ajanta Pharma Ltd, Amneal Pharms, Anbison Lab, Apotex, Cspc Ouyi, Riconpharma Llc, Sciecure Pharma Inc, Umedica, Unique Pharm, Zhejiang Jiuzhou, Zydus Pharms, Actavis Elizabeth, Bionpharma, Inwood Labs, Pliva, Rk Pharma, Unichem, Usl Pharma, and Warner Chilcott, and is included in forty-five NDAs. There are eight patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carbamazepine has seventy-eight patent family members in twenty-one countries.

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

Drug Prices for CARBAMAZEPINE

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Drug Sales Revenue Trends for CARBAMAZEPINE

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Recent Clinical Trials for CARBAMAZEPINE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Alexion Pharmaceuticals, Inc.Phase 1
Arvinas Estrogen Receptor, Inc.Phase 1
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and CompanyPhase 1

See all CARBAMAZEPINE clinical trials

Generic filers with tentative approvals for CARBAMAZEPINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up300MGCAPSULE, EXTENDED RELEASE; ORAL
⤷  Sign Up⤷  Sign Up200MGCAPSULE, EXTENDED RELEASE; ORAL
⤷  Sign Up⤷  Sign Up100MGCAPSULE, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for CARBAMAZEPINE
Anatomical Therapeutic Chemical (ATC) Classes for CARBAMAZEPINE
Paragraph IV (Patent) Challenges for CARBAMAZEPINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EQUETRO Extended-release Capsules carbamazepine 100 mg 021710 1 2014-05-23
EQUETRO Extended-release Capsules carbamazepine 200 mg and 300 mg 021710 1 2007-08-21
CARBATROL Extended-release Capsules carbamazepine 100 mg and 200 mg 020712 1 2006-02-02
TEGRETOL-XR Extended-release Tablets carbamazepine 100 mg 020234 1 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
Apotex Inc CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 078986-003 Nov 25, 2011 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Anbison Lab CARBAMAZEPINE carbamazepine TABLET, EXTENDED RELEASE;ORAL 212948-001 Sep 30, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms CARBAMAZEPINE carbamazepine TABLET, EXTENDED RELEASE;ORAL 205571-001 Feb 7, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for CARBAMAZEPINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-001 Dec 10, 2004 ⤷  Sign Up ⤷  Sign Up
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-001 Mar 25, 1996 ⤷  Sign Up ⤷  Sign Up
Takeda Pharms Usa CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-001 Sep 30, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CARBAMAZEPINE

Country Patent Number Title Estimated Expiration
Canada 2452588 METHODE DE TRAITEMENT DE TROUBLES AFFECTIFS BIPOLAIRES A L'AIDE DE CARBAMAZEPINE (METHODS FOR THE TREATMENT OF BIPOLAR DISORDER USING CARBAMAZEPINE) ⤷  Sign Up
Japan 2010539193 ⤷  Sign Up
Spain 2475157 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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 verification 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.