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Last Updated: April 27, 2024

Clobazam - Generic Drug Details

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

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

Anatomical Therapeutic Chemical (ATC) Classes for clobazam

N05BA	Benzodiazepine derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

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
Amneal	CLOBAZAM	clobazam	SUSPENSION;ORAL	210039-001	Oct 22, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	CLOBAZAM	clobazam	TABLET;ORAL	209853-002	Jun 9, 2020		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Chartwell Molecular	CLOBAZAM	clobazam	TABLET;ORAL	212092-002	Oct 30, 2019		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	CLOBAZAM	clobazam	TABLET;ORAL	211449-002	Oct 22, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Upsher Smith Labs	CLOBAZAM	clobazam	TABLET;ORAL	209687-002	Oct 22, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Upsher Smith Labs	CLOBAZAM	clobazam	SUSPENSION;ORAL	210569-001	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	210833-002	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
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	210833-003	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
Australia	2002348432		⤷ Try a Trial
Australia	2018205083	SUBLINGUAL AND BUCCAL FILM COMPOSITIONS	⤷ Try a Trial
Japan	5723601		⤷ Try a Trial
Japan	2010518241		⤷ Try a Trial
Canada	2473970	COUCHES MINCES UNIFORMES SERVANT A DISSOUDRE RAPIDEMENT UNE FORME GALENIQUE INCORPORANT DES COMPOSITIONS DE MASQUAGE DE GOUT (UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING COMPOSITIONS)	⤷ Try a Trial
China	100354699		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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