CARBAMAZEPINE - Generic Drug Details

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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, 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 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:	182
Patent Applications:	6,748
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
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

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
Teva Pharms	CARBAMAZEPINE	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	078592-001	Sep 20, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	TEGRETOL-XR	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	020234-002	Mar 25, 1996	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	CARBAMAZEPINE	carbamazepine	TABLET, EXTENDED RELEASE;ORAL	212704-002	Sep 22, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Umedica	CARBAMAZEPINE	carbamazepine	TABLET;ORAL	207798-002	Apr 15, 2020	BX	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	021710-003	Dec 10, 2004	⤷ Sign Up	⤷ Sign Up
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-002	Dec 10, 2004	⤷ Sign Up	⤷ Sign Up
Validus Pharms	EQUETRO	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	021710-002	Dec 10, 2004	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	CARBATROL	carbamazepine	CAPSULE, EXTENDED RELEASE;ORAL	020712-003	Sep 30, 1997	⤷ 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
Russian Federation	2012112839	НОВАЯ ПАРЕНТЕРАЛЬНАЯ КОМПОЗИЦИЯ КАРБАМАЗЕПИНА	⤷ Sign Up
Canada	2702603	COMPOSITIONS DE CYCLODEXTRINE A GROUPEMENTS ETHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)	⤷ Sign Up
Russian Federation	2008117161	НОВАЯ ПАРЕНТЕРАЛЬНАЯ КОМПОЗИЦИЯ КАРБАМАЗЕПИНА	⤷ Sign Up
Japan	6517725		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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