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Last Updated: July 29, 2021

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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 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, Wockhardt Bio Ag, Novartis, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Teva, Cspc Ouyi, Unique Pharm, Zydus Pharms, Actavis Elizabeth, Inwood Labs, Pliva, Umedica Labs Pvt Ltd, Usl Pharma, and Warner Chilcott, and is included in thirty-three NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are twenty-seven drug master file entries for carbamazepine. Thirty-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
Fundação Bahiana de InfectologiaPhase 3
Exvastat Ltd.Phase 2
Dr. Jurjan AmanPhase 2

See all carbamazepine clinical trials

Generic filers with tentative approvals for CARBAMAZEPINE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free300MGCAPSULE, EXTENDED RELEASE; ORAL
⤷  Try it Free⤷  Try it Free200MGCAPSULE, EXTENDED RELEASE; ORAL
⤷  Try it Free⤷  Try it Free100MGCAPSULE, 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
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
Nostrum Labs Inc CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 076697-002 May 20, 2011 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Taro CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 201106-001 Jun 21, 2013 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Apotex Inc CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 078986-002 Nov 25, 2011 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Warner Chilcott CARBAMAZEPINE carbamazepine TABLET;ORAL 070429-001 Jan 2, 1987 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Usl Pharma CARBAMAZEPINE carbamazepine TABLET;ORAL 070300-001 May 15, 1986 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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
Takeda Pharms Usa CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-002 Sep 30, 1997 ⤷  Try it Free ⤷  Try it Free
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-003 Dec 10, 2004 ⤷  Try it Free ⤷  Try it Free
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-003 Mar 25, 1996 ⤷  Try it Free ⤷  Try it Free
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-003 Mar 25, 1996 ⤷  Try it Free ⤷  Try it Free
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-002 Dec 10, 2004 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Baxter
Dow
McKinsey
Johnson and Johnson
AstraZeneca

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