CLOBAZAM - Generic Drug Details

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What are the generic 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, 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
Accord Hlthcare	CLOBAZAM	clobazam	SUSPENSION;ORAL	216008-001	Sep 6, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd Iii	CLOBAZAM	clobazam	TABLET;ORAL	209795-001	Oct 22, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Molecular	CLOBAZAM	clobazam	TABLET;ORAL	212092-002	Oct 30, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Piramal	CLOBAZAM	clobazam	TABLET;ORAL	209808-002	Oct 22, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-003	Nov 1, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Lupin Ltd	CLOBAZAM	clobazam	TABLET;ORAL	210545-002	Dec 14, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd Iii	CLOBAZAM	clobazam	TABLET;ORAL	209795-002	Oct 22, 2018	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
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018	⤷ Sign Up	⤷ Sign Up
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
>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
Spain	2735512		⤷ Sign Up
Japan	2016513736	舌下及び頬用フィルム組成物	⤷ Sign Up
World Intellectual Property Organization (WIPO)	03012531		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2007030754		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2011143424		⤷ Sign Up
Austria	553746		⤷ Sign Up
China	1610851	Package for electro-optical components	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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