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Last Updated: May 3, 2024

CLOBAZAM - Generic Drug Details

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What are the generic drug sources for clobazam and what is the scope of patent protection?

Clobazam is the generic ingredient in three branded drugs marketed by Otter Pharms, Accord Hlthcare, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Bionpharma, Chartwell Molecular, Hetero Labs Ltd Iii, Hikma, Lupin Ltd, Mylan, Taro, Teva Pharms Usa, Upsher Smith Labs, Vistapharm, Lundbeck Pharms Llc, Amneal Pharms Co, Apotex, Breckenridge, Celltrion, Micro Labs, MSN, Piramal Hlthcare Uk, and Zydus Pharms, and is included in thirty-four NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Clobazam has one hundred and sixty-eight patent family members in nineteen countries.

There are ten drug master file entries for clobazam. Twenty-three suppliers are listed for this compound.

Summary for CLOBAZAM

International Patents:	168
US Patents:	3
Tradenames:	3
Applicants:	24
NDAs:	34
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	26
Patent Applications:	6,097
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for CLOBAZAM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLOBAZAM
What excipients (inactive ingredients) are in CLOBAZAM?	CLOBAZAM excipients list
DailyMed Link:	CLOBAZAM at DailyMed

See drug prices for CLOBAZAM

Recent Clinical Trials for CLOBAZAM

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

Sponsor	Phase
Dr Cipto Mangunkusumo General Hospital	Phase 4
Wayne State University	Phase 4
Jazz Pharmaceuticals	Phase 3

See all CLOBAZAM clinical trials

Pharmacology for CLOBAZAM

Drug Class	Benzodiazepine
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers

US Patents and Regulatory Information for CLOBAZAM

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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
Lundbeck Pharms Llc	ONFI	clobazam	TABLET;ORAL	202067-002	Oct 21, 2011	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Micro Labs	CLOBAZAM	clobazam	TABLET;ORAL	211711-001	Jan 30, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amneal	CLOBAZAM	clobazam	SUSPENSION;ORAL	210039-001	Oct 22, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Chartwell Molecular	CLOBAZAM	clobazam	SUSPENSION;ORAL	213110-001	Apr 24, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Breckenridge	CLOBAZAM	clobazam	TABLET;ORAL	209308-003	Oct 19, 2021		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Taro	CLOBAZAM	clobazam	TABLET;ORAL	209440-002	Oct 22, 2018		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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 CLOBAZAM

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-003	Nov 1, 2018	⤷ Try a Trial	⤷ Try a Trial
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018	⤷ Try a Trial	⤷ Try a Trial
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-003	Nov 1, 2018	⤷ Try a Trial	⤷ Try a Trial
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018	⤷ Try a Trial	⤷ Try a Trial
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018	⤷ Try a Trial	⤷ Try a Trial
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for CLOBAZAM

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	03012531		⤷ Try a Trial
China	100445788		⤷ Try a Trial
Australia	2002348432		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2004066986		⤷ Try a Trial
European Patent Office	2120897	FILMS À BASE DE POLYMÈRES ET SYSTÈMES DE DÉLIVRANCE DE MÉDICAMENTS FABRIQUÉS À PARTIR DE CEUX-CI (POLYMER-BASED FILMS AND DRUG DELIVERY SYSTEMS MADE THEREFROM)	⤷ Try a Trial
Denmark	1587504		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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