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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKinsey
Argus Health
Cerilliant
Farmers Insurance
Deloitte
US Army
Baxter
US Department of Justice
Colorcon

Generated: February 25, 2018

DrugPatentWatch Database Preview

Carbamazepine - Generic Drug Details

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What are the generic sources for carbamazepine and what is the scope of carbamazepine freedom to operate?

Carbamazepine
is the generic ingredient in eight branded drugs marketed by Apotex Inc, Mylan Ireland Ltd, Taro, Teva Pharms, Shire, Validus Pharms, Lundbeck Pharms Llc, Wockhardt Bio Ag, Novartis, Taro Pharm, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Teva, Actavis Elizabeth, Inwood Labs, Pliva, Usl Pharma, and Warner Chilcott, and is included in twenty-nine 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 fifty-eight patent family members in nineteen countries.

There are twenty-seven drug master file entries for carbamazepine. Forty-one suppliers are listed for this compound. There is one tentative approval for this compound.
Tentative approvals for CARBAMAZEPINE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up100MGCAPSULE, EXTENDED RELEASE; ORAL
➤ Sign Up➤ Sign Up300MGCAPSULE, EXTENDED RELEASE; ORAL
➤ Sign Up➤ Sign Up200MGCAPSULE, EXTENDED RELEASE; ORAL

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 Pharms CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 078592-002 Sep 20, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Taro CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 201106-002 Jun 21, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lundbeck Pharms Llc CARNEXIV carbamazepine SOLUTION;IV (INFUSION) 206030-001 Oct 7, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-003 Dec 10, 2004 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Taro Pharm Inds CARBAMAZEPINE carbamazepine TABLET, CHEWABLE;ORAL 075687-001 Oct 24, 2000 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lundbeck Pharms Llc CARNEXIV carbamazepine SOLUTION;IV (INFUSION) 206030-001 Oct 7, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Lundbeck Pharms Llc CARNEXIV carbamazepine SOLUTION;IV (INFUSION) 206030-001 Oct 7, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva EPITOL carbamazepine TABLET, CHEWABLE;ORAL 073524-001 Jul 29, 1992 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Torrent Pharms CARBAMAZEPINE carbamazepine TABLET, CHEWABLE;ORAL 075712-001 Jul 5, 2001 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Jubilant Cadista CARBAMAZEPINE carbamazepine TABLET, CHEWABLE;ORAL 071940-001 Feb 1, 1988 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for carbamazepine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TEGRETOL carbamazepine TABLET, CHEWABLE;ORAL 018281-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-002 Mar 25, 1996 ➤ Sign Up ➤ Sign Up
Shire CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-003 Sep 30, 1997 ➤ Sign Up ➤ Sign Up
Shire CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-001 Sep 30, 1997 ➤ Sign Up ➤ Sign Up
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-002 Dec 10, 2004 ➤ Sign Up ➤ Sign Up
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-003 Mar 25, 1996 ➤ Sign Up ➤ Sign Up
Novartis TEGRETOL carbamazepine SUSPENSION;ORAL 018927-001 Dec 18, 1987 ➤ Sign Up ➤ Sign Up
Shire CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-002 Sep 30, 1997 ➤ Sign Up ➤ Sign Up
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-001 Dec 10, 2004 ➤ Sign Up ➤ Sign Up
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-002 Dec 10, 2004 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for carbamazepine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,200,088 Sulfoalkyl ether cyclodextrin compositions ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for carbamazepine

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
McKesson
Accenture
Cipla
Julphar
Mallinckrodt
Citi
Express Scripts
Farmers Insurance

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 verifification 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.

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