Carbamazepine - Generic Drug Details

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What are the generic 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, Chartwell Rx, Novitium Pharma, Novartis, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Teva, Ajanta Pharma Ltd, Amneal Pharms, Anbison Lab, Apotex, Cspc Ouyi, Riconpharma Llc, Sciecure Pharma Inc, Umedica, Unique Pharm, Zhejiang Jiuzhou, Zydus Pharms, Actavis Elizabeth, Bionpharma, Inwood Labs, Pliva, Rk Pharma, Unichem, Usl Pharma, and Warner Chilcott, and is included in forty-five NDAs. There are eight patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carbamazepine has seventy-eight patent family members in twenty-one countries.

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

Summary for carbamazepine

International Patents:	78
US Patents:	8
Tradenames:	8
Applicants:	33
NDAs:	45
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	46
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	178
Patent Applications:	7,169
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

Drug Sales Revenue Trends for carbamazepine

See drug sales revenues for carbamazepine

Recent Clinical Trials for carbamazepine

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

Sponsor	Phase
Alexion Pharmaceuticals, Inc.	Phase 1
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company	Phase 1
Aligos Therapeutics	Phase 1

See all carbamazepine clinical trials

Generic filers with tentative approvals for CARBAMAZEPINE

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

Anatomical Therapeutic Chemical (ATC) Classes for carbamazepine

N03AF	Carboxamide derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cspc Ouyi	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	213311-002	Apr 13, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex Inc	CARBAMAZEPINE	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	078986-002	Nov 25, 2011	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
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-001	Mar 25, 1996	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	TERIL	carbamazepine	SUSPENSION;ORAL	076729-001	Sep 20, 2004	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	078115-001	Mar 31, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	213159-002	Mar 8, 2024	AB	RX	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

Expired US Patents for carbamazepine

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

International Patents for carbamazepine

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Country	Patent Number	Title	Estimated Expiration
Japan	2013040195	NEW PARENTERAL CARBAMAZEPINE FORMULATION	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2020157257		⤷ Sign Up
South Korea	101314803		⤷ Sign Up
Portugal	1928464		⤷ Sign Up
Australia	2013226073	Alkylated cyclodextrin compositions and processes for preparing and using the same	⤷ Sign Up
Japan	6444548		⤷ Sign Up
Canada	2624463	NOUVELLE PREPARATION A BASE DE CARBAMAZEPINE A ADMINISTRATION PAR VOIE PARENTERALE (NOVEL PARENTERAL CARBAMAZEPINE FORMULATION)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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