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Last Updated: January 25, 2022

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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, 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, Zydus Pharms, Actavis Elizabeth, Inwood Labs, Pliva, Umedica Labs Pvt Ltd, Usl Pharma, Vgyaan, and Warner Chilcott, and is included in thirty-five 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-five patent family members in twenty-one countries.

There are twenty-seven drug master file entries for carbamazepine. Thirty-seven 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
Postgraduate Institute of Dental Sciences RohtakPhase 4
BayerPhase 1
Hospital Israelita Albert EinsteinPhase 4

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Generic filers with tentative approvals for CARBAMAZEPINE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free100MGCAPSULE, EXTENDED RELEASE; ORAL
⤷  Try it Free⤷  Try it Free300MGCAPSULE, EXTENDED RELEASE; ORAL
⤷  Try it Free⤷  Try it Free200MGCAPSULE, 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
Warner Chilcott CARBAMAZEPINE carbamazepine TABLET;ORAL 070429-001 Jan 2, 1987 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Torrent Pharms CARBAMAZEPINE carbamazepine TABLET, CHEWABLE;ORAL 075712-001 Jul 5, 2001 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Taro TERIL carbamazepine TABLET;ORAL 076525-001 Sep 26, 2003 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
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
Teva Pharms CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 078592-002 Sep 20, 2012 AB RX 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
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
Novartis TEGRETOL carbamazepine TABLET, CHEWABLE;ORAL 018281-001 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-001 Dec 10, 2004 ⤷  Try it Free ⤷  Try it Free
Takeda Pharms Usa CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-003 Sep 30, 1997 ⤷  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:

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Johnson and Johnson
Moodys
McKesson

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.