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Last Updated: April 28, 2024

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, 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
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Micro Labs	CLOBAZAM	clobazam	TABLET;ORAL	211711-002	Jan 30, 2019	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
Lupin Ltd	CLOBAZAM	clobazam	TABLET;ORAL	210545-002	Dec 14, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alkem Labs Ltd	CLOBAZAM	clobazam	TABLET;ORAL	212714-002	Sep 6, 2019	AB	RX	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
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)	⤷ Try a Trial
Japan	2021536466	厳密な活性剤溶解プロファイルを有する口腔用フィルム組成物及び剤形	⤷ Try a Trial
Canada	2581851	FILMS MULTICOUCHES PRESENTANT UN CONTENU UNIFORME (MULTI-LAYER FILMS HAVING UNIFORM CONTENT)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2006039264		⤷ Try a Trial
Australia	2004319243	Polyethylene oxide-based films and drug delivery systems made therefrom	⤷ Try a Trial
Japan	2013501718		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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