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, Norvium Bioscience, Taro, Teva Pharms Usa, Upsher Smith Labs, Vistapharm, Lundbeck Pharms Llc, Amneal Pharms Co, Anda Repository, Apotex, Breckenridge, Micro Labs, MSN, Piramal, 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:	6,022
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
Anda Repository	CLOBAZAM	clobazam	TABLET;ORAL	211959-002	Dec 9, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	CLOBAZAM	clobazam	TABLET;ORAL	209687-001	Oct 22, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	CLOBAZAM	clobazam	SUSPENSION;ORAL	214404-001	Mar 24, 2022	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

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	⤷ Sign Up	⤷ Sign Up
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018	⤷ Sign Up	⤷ Sign Up
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018	⤷ Sign Up	⤷ Sign Up
>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
Mexico	2015013184	COMPOSICIONES DE PELICULAS SUBLINGUAL Y BUCAL. (SUBLINGUAL AND BUCCAL FILM COMPOSITIONS.)	⤷ Sign Up
Russian Federation	2015143647	ПЛЕНОЧНЫЕ КОМПОЗИЦИИ ДЛЯ СУБЛИНГВАЛЬНОГО И БУККАЛЬНОГО ВВЕДЕНИЯ	⤷ Sign Up
European Patent Office	2335921	Films multicouches (Multi-layer films)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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