Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
AstraZeneca
Express Scripts
McKinsey
Colorcon

Last Updated: September 24, 2022

Carbamazepine - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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, Anbison Lab, Cspc Ouyi, Unique Pharm, Zhejiang Jiuzhou, Zydus Pharms, Actavis Elizabeth, Inwood Labs, Pliva, Umedica Labs Pvt Ltd, Usl Pharma, Vgyaan, and Warner Chilcott, and is included in thirty-six 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. Thirty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for carbamazepine

See drug prices for carbamazepine

Drug Sales Revenue Trends for carbamazepine

See drug sales revenues for carbamazepine

Recent Clinical Trials for carbamazepine

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

SponsorPhase
BiocodexPhase 4
RenJi HospitalPhase 4
Assiut UniversityN/A

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
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
Warner Chilcott CARBAMAZEPINE carbamazepine TABLET;ORAL 070429-001 Jan 2, 1987 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva EPITOL carbamazepine TABLET, CHEWABLE;ORAL 073524-001 Jul 29, 1992 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 078592-001 Sep 20, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex Inc CARBAMAZEPINE carbamazepine TABLET;ORAL 075948-001 Feb 27, 2002 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms CARBAMAZEPINE carbamazepine TABLET, EXTENDED RELEASE;ORAL 205571-002 Feb 7, 2019 AB RX 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
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-002 Dec 10, 2004 See Plans and Pricing See Plans and Pricing
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-001 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
Takeda Pharms Usa CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-003 Sep 30, 1997 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
Mexico 352459 COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.) See Plans and Pricing
South Korea 20150004797 ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME See Plans and Pricing
Canada 2771879 COMPOSITIONS DE CYCLODEXTRINE A GROUPEMENTS ETHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) See Plans and Pricing
Russian Federation 2016140391 КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ See Plans and Pricing
Mexico 2014010323 COMPOSICIONES DE CICLODEXTRINA ALQUILADA Y PROCESOS PARA PREPARAR Y UTILIZAR LAS MISMAS. (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Baxter
Dow
McKinsey
Johnson and Johnson
AstraZeneca

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.