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Last Updated: August 3, 2020

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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, Shire Dev Llc, Validus Pharms, Lundbeck Pharms Llc, Wockhardt Bio Ag, Novartis, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Teva, Unique Pharm, Zydus Pharms, Actavis Elizabeth, Inwood Labs, Pliva, Umedica Labs Pvt Ltd, Usl Pharma, and Warner Chilcott, and is included in thirty-two 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-three patent family members in twenty-one countries.

There are twenty-seven drug master file entries for carbamazepine. Thirty-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

SponsorPhase
Temple UniversityPhase 4
Eisai Inc.Phase 4
Veloxis PharmaceuticalsPhase 4

See all CARBAMAZEPINE clinical trials

Generic filers with tentative approvals for CARBAMAZEPINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial300MGCAPSULE, EXTENDED RELEASE; ORAL
  Start Trial  Start Trial200MGCAPSULE, EXTENDED RELEASE; ORAL
  Start Trial  Start 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
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
Teva EPITOL carbamazepine TABLET, CHEWABLE;ORAL 073524-001 Jul 29, 1992 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms CARBAMAZEPINE carbamazepine TABLET, EXTENDED RELEASE;ORAL 205571-002 Feb 7, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Taro Pharm Inds CARBAMAZEPINE carbamazepine TABLET, CHEWABLE;ORAL 075687-001 Oct 24, 2000 AB RX No No   Start Trial   Start Trial   Start Trial
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-001 Dec 10, 2004 RX Yes No   Start Trial   Start Trial   Start 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
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-003 Dec 10, 2004   Start Trial   Start Trial
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-002 Dec 10, 2004   Start Trial   Start Trial
Shire Dev Llc CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-002 Sep 30, 1997   Start Trial   Start Trial
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-003 Mar 25, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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