By tracking patent expirations, patent litigation, generic and biosimilar development, you can anticipate these market-shaping forces and stay one step ahead.
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SYMPAZAN Drug Profile
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When do Sympazan patents expire, and when can generic versions of Sympazan launch?
Sympazan is a drug marketed by Aquestive and is included in one NDA. There are two patents protecting this drug.
This drug has one hundred and sixty-one patent family members in eighteen countries.
The generic ingredient in SYMPAZAN is clobazam. There are ten drug master file entries for this compound. Twenty 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: | 161 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| 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 |
ATC Classes for SYMPAZAN
US Patents and Regulatory Information for SYMPAZAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aquestive | SYMPAZAN | clobazam | FILM;ORAL | 210833-001 | Nov 1, 2018 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Aquestive | SYMPAZAN | clobazam | FILM;ORAL | 210833-002 | Nov 1, 2018 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Aquestive | SYMPAZAN | clobazam | FILM;ORAL | 210833-001 | Nov 1, 2018 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Aquestive | SYMPAZAN | clobazam | FILM;ORAL | 210833-002 | Nov 1, 2018 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Aquestive | SYMPAZAN | clobazam | FILM;ORAL | 210833-003 | Nov 1, 2018 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| Aquestive | SYMPAZAN | clobazam | FILM;ORAL | 210833-003 | Nov 1, 2018 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Try Before You Buy | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for SYMPAZAN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2014144241 | Try Before You Buy |
| World Intellectual Property Organization (WIPO) | 2007075422 | Try Before You Buy |
| Australia | 2002362772 | Try Before You Buy |
| Denmark | 1463491 | Try Before You Buy |
| Russian Federation | 2015143647 | Try Before You Buy |
| Mexico | 2015013184 | Try Before You Buy |
| European Patent Office | 2428206 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
