SYMPAZAN Drug Patent Profile

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Which patents cover Sympazan, and when can generic versions of Sympazan launch?

Sympazan is a drug marketed by Otter Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and sixty-eight patent family members in nineteen countries.

The generic ingredient in SYMPAZAN is clobazam. There are ten drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the clobazam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sympazan

A generic version of SYMPAZAN was approved as clobazam by AMNEAL on October 22^nd, 2018.

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Summary for SYMPAZAN

International Patents:	168
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	37
Patent Applications:	3,805
Drug Prices:	Drug price information for SYMPAZAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYMPAZAN
What excipients (inactive ingredients) are in SYMPAZAN?	SYMPAZAN excipients list
DailyMed Link:	SYMPAZAN at DailyMed

Drug patent expirations by year for SYMPAZAN

Pharmacology for SYMPAZAN

Drug Class	Benzodiazepine
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers

US Patents and Regulatory Information for SYMPAZAN

SYMPAZAN is protected by three US patents.

Patents protecting SYMPAZAN

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING SEIZURES

Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
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Patent Expiration: ⤷ Sign Up

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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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-003	Nov 1, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-003	Nov 1, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-001	Nov 1, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Otter Pharms	SYMPAZAN	clobazam	FILM;ORAL	210833-002	Nov 1, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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 SYMPAZAN

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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 SYMPAZAN

See the table below for patents covering SYMPAZAN around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	2008216887	Polymer-based films and drug delivery systems made therefrom	⤷ Sign Up
World Intellectual Property Organization (WIPO)	02103441		⤷ Sign Up
Japan	2011050394	MULTI-LAYER FILM HAVING UNIFORM CONTENT	⤷ Sign Up
Australia	2010214780	Polyethylene oxide-based films and drug delivery systems made therefrom	⤷ Sign Up
Spain	2444951		⤷ Sign Up
China	101321511	Topical film compositions for delivery of actives	⤷ Sign Up
South Korea	20040035708		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for SYMPAZAN

Pharmacology for SYMPAZAN

Patents protecting SYMPAZAN

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