SYMPAZAN Drug Patent Profile
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When do Sympazan patents expire, 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 22nd, 2018.
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 |
Pharmacology for SYMPAZAN
| Drug Class | Benzodiazepine |
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers |
Anatomical Therapeutic Chemical (ATC) Classes for SYMPAZAN
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
| 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 | |||
| Otter Pharms | SYMPAZAN | clobazam | FILM;ORAL | 210833-003 | Nov 1, 2018 | RX | Yes | Yes | ⤷ 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 | 210833-002 | 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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 2568975 | COMPOSITIONS EN FILM POUR LA DISTRIBUTION D'AGENTS ACTIFS (FILM COMPOSITIONS FOR DELIVERY OF ACTIVES) | ⤷ Try a Trial |
| Mexico | 2015013184 | COMPOSICIONES DE PELICULAS SUBLINGUAL Y BUCAL. (SUBLINGUAL AND BUCCAL FILM COMPOSITIONS.) | ⤷ Try a Trial |
| Australia | 2002332118 | ⤷ Try a Trial | |
| Japan | 2004537750 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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