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Last Updated: January 27, 2023

Carbamazepine - Generic Drug Details


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What are the generic drug 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, Novitium Pharma, Wockhardt Bio Ag, Novartis, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Teva, Anbison Lab, Cspc Ouyi, Riconpharma Llc, Umedica Labs Pvt Ltd, Unique Pharm, Zhejiang Jiuzhou, Zydus Pharms, Actavis Elizabeth, Inwood Labs, Pliva, Unichem, Usl Pharma, Vgyaan, and Warner Chilcott, and is included in forty 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-six patent family members in twenty-one countries.

There are twenty-seven drug master file entries for carbamazepine. Forty-four 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
Kathmandu UniversityPhase 4
Asian Pharmaceuticals Pvt. Ltd.Phase 4
Cerevel Therapeutics, LLCPhase 1

See all carbamazepine clinical trials

Generic filers with tentative approvals for CARBAMAZEPINE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing300MGCAPSULE, EXTENDED RELEASE; ORAL
See Plans and PricingSee Plans and Pricing200MGCAPSULE, EXTENDED RELEASE; ORAL
See Plans and PricingSee Plans and Pricing100MGCAPSULE, 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 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zhejiang Jiuzhou CARBAMAZEPINE carbamazepine TABLET, EXTENDED RELEASE;ORAL 215591-002 Mar 31, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Taro CARBAMAZEPINE carbamazepine TABLET, EXTENDED RELEASE;ORAL 078115-002 Mar 31, 2009 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Jubilant Cadista CARBAMAZEPINE carbamazepine TABLET, CHEWABLE;ORAL 071940-001 Feb 1, 1988 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-003 Mar 25, 1996 See Plans and Pricing See Plans and Pricing
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-002 Dec 10, 2004 See Plans and Pricing See Plans and Pricing
Novartis TEGRETOL carbamazepine TABLET, CHEWABLE;ORAL 018281-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-001 Dec 10, 2004 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for carbamazepine

Country Patent Number Title Estimated Expiration
Japan 4923144 See Plans and Pricing
Russian Federation 2615385 КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME RELATED APPLICATIONS) See Plans and Pricing
Spain 2475157 See Plans and Pricing
Canada 2624463 NOUVELLE PREPARATION A BASE DE CARBAMAZEPINE A ADMINISTRATION PAR VOIE PARENTERALE (NOVEL PARENTERAL CARBAMAZEPINE FORMULATION) See Plans and Pricing
>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.