Carbamazepine - Generic Drug Details

What are the generic drug 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, Takeda Pharms Usa, Validus Pharms, Lundbeck Pharms Llc, Novitium Pharma, Wockhardt Bio Ag, Novartis, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Teva, Anbison Lab, Cspc Ouyi, Riconpharma Llc, Umedica Labs Pvt Ltd, Unique Pharm, Zhejiang Jiuzhou, Zydus Pharms, Actavis Elizabeth, Inwood Labs, Pliva, Unichem, Usl Pharma, Vgyaan, and Warner Chilcott, and is included in forty 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-six patent family members in twenty-one countries.

There are twenty-seven drug master file entries for carbamazepine. Forty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for carbamazepine

International Patents:	76
US Patents:	7
Tradenames:	8
Applicants:	28
NDAs:	40
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	156
Clinical Trials:	171
Patent Applications:	7,015
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for carbamazepine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carbamazepine
What excipients (inactive ingredients) are in carbamazepine?	carbamazepine excipients list
DailyMed Link:	carbamazepine at DailyMed

See drug prices for carbamazepine

See drug sales revenues for carbamazepine

Recent Clinical Trials for carbamazepine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Kathmandu University	Phase 4
Asian Pharmaceuticals Pvt. Ltd.	Phase 4
Cerevel Therapeutics, LLC	Phase 1

See all carbamazepine clinical trials

Generic filers with tentative approvals for CARBAMAZEPINE

Applicant	Application No.	Strength	Dosage Form
		300MG	CAPSULE, EXTENDED RELEASE; ORAL
		200MG	CAPSULE, EXTENDED RELEASE; ORAL
		100MG	CAPSULE, 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.

Pharmacology for carbamazepine

Drug Class	Mood Stabilizer
Mechanism of Action	Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for carbamazepine

Analgesics, Non-Narcotic

Anticonvulsants

Antimanic Agents

Cytochrome P-450 CYP3A Inducers

Paragraph IV (Patent) Challenges for CARBAMAZEPINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EQUETRO	Extended-release Capsules	carbamazepine	100 mg	021710	1	2014-05-23
EQUETRO	Extended-release Capsules	carbamazepine	200 mg and 300 mg	021710	1	2007-08-21
CARBATROL	Extended-release Capsules	carbamazepine	100 mg and 200 mg	020712	1	2006-02-02
TEGRETOL-XR	Extended-release Tablets	carbamazepine	100 mg	020234	1	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
Lundbeck Pharms Llc	CARNEXIV	carbamazepine	SOLUTION;INTRAVENOUS	206030-001	Oct 7, 2016		DISCN	Yes	No
Zhejiang Jiuzhou	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	215591-002	Mar 31, 2022	AB	RX	No	No
Taro	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	078115-002	Mar 31, 2009	AB	RX	No	No
Jubilant Cadista	CARBAMAZEPINE	carbamazepine	TABLET, CHEWABLE;ORAL	071940-001	Feb 1, 1988		DISCN	No	No

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
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-002	Dec 10, 2004
Novartis	TEGRETOL	carbamazepine	TABLET, CHEWABLE;ORAL	018281-001	Approved Prior to Jan 1, 1982
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-001	Dec 10, 2004

International Patents for carbamazepine

Country	Patent Number	Title	Estimated Expiration
Japan	4923144
Russian Federation	2615385	КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME RELATED APPLICATIONS)
Spain	2475157
Canada	2624463	NOUVELLE PREPARATION A BASE DE CARBAMAZEPINE A ADMINISTRATION PAR VOIE PARENTERALE (NOVEL PARENTERAL CARBAMAZEPINE FORMULATION)