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Last Updated: November 21, 2024

CARBAMAZEPINE Drug Patent Profile

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When do Carbamazepine patents expire, and when can generic versions of Carbamazepine launch?

Carbamazepine is a drug marketed by Apotex Inc, Nostrum Labs Inc, Taro, Teva Pharms, Chartwell Rx, Novitium Pharma, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Ajanta Pharma Ltd, Amneal Pharms, Anbison Lab, Apotex, Cspc Ouyi, Epic Pharma Llc, Novast Labs, 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 thirty-four NDAs.

The generic ingredient in CARBAMAZEPINE is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Carbamazepine

A generic version of CARBAMAZEPINE was approved as carbamazepine by TARO on October 3^rd, 1996.

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Summary for CARBAMAZEPINE

US Patents:	0
Applicants:	28
NDAs:	34
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	182
Patent Applications:	2,603
Drug Prices:	Drug price information 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

Drug patent expirations by year for CARBAMAZEPINE

Drug Prices for CARBAMAZEPINE

Recent Clinical Trials for CARBAMAZEPINE

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

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

See all CARBAMAZEPINE clinical trials

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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	078115-001	Mar 31, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cspc Ouyi	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	213311-001	Apr 13, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Unique Pharm	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	211623-003	Apr 24, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pliva	CARBAMAZEPINE	carbamazepine	TABLET;ORAL	071479-001	Jul 24, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Umedica	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	216594-002	Aug 18, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zhejiang Jiuzhou	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	215591-001	Mar 31, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	205571-003	Feb 7, 2019	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

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