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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
US Army
Merck
UBS
Baxter
Accenture
Argus Health
Mallinckrodt
Daiichi Sankyo

Generated: January 21, 2018

DrugPatentWatch Database Preview

CARBAMAZEPINE - Generic Drug Details

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What are the generic drug 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, 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-two suppliers are listed for this compound. There is one tentative approval for this compound.
Tentative approvals for CARBAMAZEPINE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe100MGCAPSULE, EXTENDED RELEASE; ORAL
➤ Subscribe➤ Subscribe300MGCAPSULE, EXTENDED RELEASE; ORAL
➤ Subscribe➤ Subscribe200MGCAPSULE, 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
Lundbeck Pharms Llc CARNEXIV carbamazepine SOLUTION;IV (INFUSION) 206030-001 Oct 7, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Taro CARBAMAZEPINE carbamazepine SUSPENSION;ORAL 075875-001 Dec 21, 2000 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Pharms CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 078592-003 Sep 20, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Lundbeck Pharms Llc CARNEXIV carbamazepine SOLUTION;IV (INFUSION) 206030-001 Oct 7, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Warner Chilcott CARBAMAZEPINE carbamazepine TABLET;ORAL 070429-001 Jan 2, 1987 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis TEGRETOL carbamazepine TABLET;ORAL 016608-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Taro CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 201106-003 Jun 21, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Wockhardt CARBAMAZEPINE carbamazepine SUSPENSION;ORAL 075714-001 Jun 5, 2002 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apotex Inc CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 078986-001 Nov 25, 2011 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-002 Dec 10, 2004 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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
Shire CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-002 Sep 30, 1997 ➤ Subscribe ➤ Subscribe
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-003 Dec 10, 2004 ➤ Subscribe ➤ Subscribe
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-003 Mar 25, 1996 ➤ Subscribe ➤ Subscribe
Shire CARBATROL carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 020712-003 Sep 30, 1997 ➤ Subscribe ➤ Subscribe
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-003 Mar 25, 1996 ➤ Subscribe ➤ Subscribe
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-001 Dec 10, 2004 ➤ Subscribe ➤ Subscribe
Novartis TEGRETOL-XR carbamazepine TABLET, EXTENDED RELEASE;ORAL 020234-001 Mar 25, 1996 ➤ Subscribe ➤ Subscribe
Novartis TEGRETOL carbamazepine TABLET, CHEWABLE;ORAL 018281-001 Approved Prior to Jan 1, 1982 ➤ Subscribe ➤ Subscribe
Validus Pharms EQUETRO carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 021710-003 Dec 10, 2004 ➤ Subscribe ➤ Subscribe
Novartis TEGRETOL carbamazepine SUSPENSION;ORAL 018927-001 Dec 18, 1987 ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for CARBAMAZEPINE

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Serving leading biopharmaceutical companies globally:

Dow
Novartis
Moodys
Cerilliant
Daiichi Sankyo
Julphar
Merck
Federal Trade Commission
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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