CARBAMAZEPINE - Generic Drug Details

What are the generic drug sources for carbamazepine and what is the scope of freedom to operate?

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-five 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:	45
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	176
Patent Applications:	6,998
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
Aligos Therapeutics	Phase 1
Dr Cipto Mangunkusumo General Hospital	Phase 4
Asian Pharmaceuticals Pvt. Ltd.	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 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
Taro	CARBAMAZEPINE	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	201106-001	Jun 21, 2013	AB	RX	No	No
Jubilant Cadista	CARBAMAZEPINE	carbamazepine	TABLET, CHEWABLE;ORAL	071940-001	Feb 1, 1988		DISCN	No	No
Amneal Pharms	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	212704-003	Sep 22, 2023		DISCN	No	No
Taro Pharm Inds	CARBAMAZEPINE	carbamazepine	TABLET, CHEWABLE;ORAL	075687-002	Jul 29, 2002		RX	No	Yes
Torrent Pharms	CARBAMAZEPINE	carbamazepine	TABLET;ORAL	077272-004	Dec 7, 2005		RX	No	No
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-001	Sep 30, 1997	AB	RX	Yes	No
Umedica	CARBAMAZEPINE	carbamazepine	TABLET;ORAL	207798-001	Apr 15, 2020	AB	RX	No	No

Expired US Patents for CARBAMAZEPINE

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

International Patents for CARBAMAZEPINE

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0905080	Composições, processo para reparar uma composição e produto
South Korea	101314803
Brazil	PI0616447	complexo de inclusão de carbamazepina-ciclodextrina, método de administrar e método de preparar o mesmo
Mexico	2010004900	COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.)
Japan	2016166368	アルキル化シクロデキストリン組成物ならびにその調製方法および使用方法 (ALKYLATED CYCLODEXTRIN COMPOSITION AS WELL AS PREPARATION METHOD AND USE METHOD THEREOF)
Russian Federation	2747757	КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (COMPOSITIONS OF ALKYLATED CYCLODEXTRIN AND METHODS OF THEIR PREPARATION AND APPLICATION)
Russian Federation	2016140391	КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ