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

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

Summary for carbamazepine

International Patents:	73
US Patents:	7
Tradenames:	8
Applicants:	21
NDAs:	32
Drug Master File Entries:	27
Suppliers / Packagers:	36
Bulk Api Vendors:	133
Clinical Trials:	141
Patent Applications:	6,712
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for carbamazepine
Drug Sales Revenues:	Drug sales revenues for carbamazepine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carbamazepine
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
Assiut University	Phase 4
University of Colorado, Denver	Phase 4
Merck Sharp & Dohme Corp.	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
Umedica Labs Pvt Ltd	CARBAMAZEPINE	carbamazepine	TABLET;ORAL	207798-001	Apr 15, 2020	AB	RX	No	No
Taro	CARBAMAZEPINE	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	201106-002	Jun 21, 2013	AB	RX	No	No
Unique Pharm	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	211623-002	Apr 24, 2020	AB	RX	No	No
Torrent Pharms	CARBAMAZEPINE	carbamazepine	TABLET, CHEWABLE;ORAL	075712-001	Jul 5, 2001	AB	RX	No	No
Lundbeck Pharms Llc	CARNEXIV	carbamazepine	SOLUTION;INTRAVENOUS	206030-001	Oct 7, 2016		DISCN	Yes	No			Y
Unique Pharm	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	211623-003	Apr 24, 2020	AB	RX	No	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
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-002	Dec 10, 2004
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-003	Mar 25, 1996
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-003	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

International Patents for carbamazepine

Country	Patent Number	Estimated Expiration
South Korea	20150004797
European Patent Office	2748205
New Zealand	589290
Japan	2018052991
European Patent Office	2444090
Japan	5794966