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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 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, Wockhardt Bio Ag, Novartis, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Teva, 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-four 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.

Summary for carbamazepine

International Patents:	75
US Patents:	7
Tradenames:	8
Applicants:	23
NDAs:	34
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	152
Patent Applications:	5,542
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
Bayer	Phase 1
Hospital Israelita Albert Einstein	Phase 4
Industria Farmacêutica Health Meds	Phase 4

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 3A4 Inducers Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 2C19 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	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
Teva	EPITOL	carbamazepine	TABLET, CHEWABLE;ORAL	073524-001	Jul 29, 1992	AB	RX	No	No
Lundbeck Pharms Llc	CARNEXIV	carbamazepine	SOLUTION;INTRAVENOUS	206030-001	Oct 7, 2016		DISCN	Yes	No			Y
Lundbeck Pharms Llc	CARNEXIV	carbamazepine	SOLUTION;INTRAVENOUS	206030-001	Oct 7, 2016		DISCN	Yes	No			Y
Taro	CARBAMAZEPINE	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	201106-001	Jun 21, 2013	AB	RX	No	No
Apotex Inc	CARBAMAZEPINE	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	078986-003	Nov 25, 2011	AB	RX	No	No
Taro	TERIL	carbamazepine	TABLET;ORAL	076525-001	Sep 26, 2003		DISCN	No	No
Novartis	TEGRETOL	carbamazepine	TABLET, CHEWABLE;ORAL	018281-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for carbamazepine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-001	Sep 30, 1997
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-001	Mar 25, 1996
Novartis	TEGRETOL	carbamazepine	SUSPENSION;ORAL	018927-001	Dec 18, 1987
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-003	Dec 10, 2004
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-002	Mar 25, 1996
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-003	Sep 30, 1997
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-002	Sep 30, 1997

International Patents for carbamazepine

Country	Patent Number	Estimated Expiration
New Zealand	589290
Japan	6517725
Japan	2015110671
Spain	2708375
China	104704007
Australia	2009241858
Japan	2013040195