SYMPAZAN Drug Patent Profile

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Which patents cover Sympazan, and what generic alternatives are available?

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:	3,999
Formulation / Manufacturing:	see details
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

Anatomical Therapeutic Chemical (ATC) Classes for SYMPAZAN

N05BA	Benzodiazepine derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for SYMPAZAN

SYMPAZAN is protected by three US patents.

Patents protecting SYMPAZAN

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING SEIZURES

Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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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	210833-003	Nov 1, 2018		RX	Yes	Yes	⤷ 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
>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	210833-002	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
>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
Mexico	PA05012815	PELICULAS BASADAS EN OXIDO DE POLIETILENO Y SISTEMAS PARA SUMINISTRO DE FÁRMACOS ELABORADOS CON ELLAS. (POLYETHYLENE OXIDE-BASED FILMS AND DRUG DELIVERY SYSTEMS MADE THEREFROM.)	⤷ Try a Trial
South Korea	20160029730	설하 및 구강 필름 조성물 (SUBLINGUAL AND BUCCAL FILM COMPOSITIONS)	⤷ Try a Trial
Japan	2009518405		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Summary for SYMPAZAN

Pharmacology for SYMPAZAN

Anatomical Therapeutic Chemical (ATC) Classes for SYMPAZAN

Patents protecting SYMPAZAN

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