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Last Updated: March 1, 2024

Carbamazepine - Generic Drug Details

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What are the generic sources for carbamazepine and what is the scope of patent protection?

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, Cspc Ouyi, Riconpharma Llc, Sciecure Pharma Inc, Umedica, Unique Pharm, Zhejiang Jiuzhou, Zydus Pharms, Actavis Elizabeth, Inwood Labs, Pliva, Rk Pharma, Unichem, Usl Pharma, and Warner Chilcott, and is included in forty-three 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-five 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

Aligos TherapeuticsPhase 1
Dr Cipto Mangunkusumo General HospitalPhase 4
Kathmandu UniversityPhase 4

See all carbamazepine clinical trials

Generic filers with tentative approvals for CARBAMAZEPINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial300MGCAPSULE, EXTENDED RELEASE; ORAL
⤷  Try a Trial⤷  Try a Trial200MGCAPSULE, EXTENDED RELEASE; ORAL
⤷  Try a Trial⤷  Try a Trial100MGCAPSULE, 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
Lundbeck Pharms Llc CARNEXIV carbamazepine SOLUTION;INTRAVENOUS 206030-001 Oct 7, 2016 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Taro CARBAMAZEPINE carbamazepine SUSPENSION;ORAL 075875-001 Dec 21, 2000 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Umedica CARBAMAZEPINE carbamazepine TABLET, EXTENDED RELEASE;ORAL 216594-002 Aug 18, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Novartis TEGRETOL carbamazepine TABLET;ORAL 016608-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-001 Mar 25, 1996 ⤷  Try a Trial ⤷  Try a Trial
Novartis TEGRETOL carbamazepine SUSPENSION;ORAL 018927-001 Dec 18, 1987 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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