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Last Updated: July 6, 2020

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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, 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

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

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Generic filers with tentative approvals for CARBAMAZEPINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial100MGCAPSULE, EXTENDED RELEASE; ORAL
  Start Trial  Start Trial300MGCAPSULE, EXTENDED RELEASE; ORAL
  Start Trial  Start Trial200MGCAPSULE, 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
Shire Dev Llc CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-001 Sep 30, 1997 AB RX Yes No   Start Trial   Start Trial   Start Trial
Torrent Pharms CARBAMAZEPINE carbamazepine TABLET;ORAL 077272-002 Dec 7, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Nostrum Labs Inc CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 076697-001 May 20, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Taro CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 201106-001 Jun 21, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Shire Dev Llc CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-002 Sep 30, 1997 AB RX Yes Yes   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
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-003 Mar 25, 1996   Start Trial   Start Trial
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-001 Mar 25, 1996   Start Trial   Start Trial
Shire Dev Llc CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-002 Sep 30, 1997   Start Trial   Start Trial
Shire Dev Llc CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-003 Sep 30, 1997   Start Trial   Start Trial
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-001 Dec 10, 2004   Start Trial   Start Trial
>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

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.