Clobazam - Generic Drug Details

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bionpharma	CLOBAZAM	clobazam	TABLET;ORAL	208825-001	Oct 22, 2018	AB	RX	No	No
Accord Hlthcare	CLOBAZAM	clobazam	SUSPENSION;ORAL	216008-001	Sep 6, 2022		DISCN	No	No
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018		RX	Yes	No			Y
Accord Hlthcare	CLOBAZAM	clobazam	TABLET;ORAL	212398-001	May 23, 2019		DISCN	No	No
Celltrion	CLOBAZAM	clobazam	TABLET;ORAL	211959-001	Dec 9, 2020		DISCN	No	No
Mylan	CLOBAZAM	clobazam	SUSPENSION;ORAL	211259-001	Oct 22, 2018		DISCN	No	No
Lundbeck Pharms Llc	ONFI	clobazam	TABLET;ORAL	202067-003	Oct 21, 2011	AB	RX	Yes	Yes

Expired US Patents for clobazam

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

International Patents for clobazam

Country	Patent Number	Title	Estimated Expiration
Japan	2015129183	自己凝集しない均一な異種性を有する薄膜、その生成方法、およびそれから製造した薬物送達系 (THIN FILMS WITH NON-SELF-AGGREGATING UNIFORM HETEROGENEITY, PRODUCTION METHODS THEREOF, AND DRUG DELIVERY SYSTEMS MADE THEREOF)
Spain	2624003
Australia	2020200651	SUBLINGUAL AND BUCCAL FILM COMPOSITIONS
Austria	553746
China	112955124	具有精确的活性物溶出谱的口腔膜组合物和剂型 (ORAL FILM COMPOSITIONS AND DOSAGE FORMS HAVING PRECISE ACTIVE DISSOLUTION PROFILES)
European Patent Office	1463490	SYSTEMES DE DISTRIBUTION DE SUBSTANCE ACTIVE SOUS FORME DE FILM A BASE DE GLUCANE (GLUCAN BASED FILM DELIVERY SYSTEMS)
Japan	6109865