felbamate - Profile
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What are the generic drug sources for felbamate and what is the scope of patent protection?
Felbamate
is the generic ingredient in two branded drugs marketed by Amneal Pharms, Novitium Pharma, Taro, Mylan Speciality Lp, Alvogen, Ani Pharms, and Zydus Lifesciences, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.Summary for felbamate
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 7 |
| NDAs: | 9 |
US Patents and Regulatory Information for felbamate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms | FELBAMATE | felbamate | SUSPENSION;ORAL | 202385-001 | Dec 16, 2011 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Novitium Pharma | FELBAMATE | felbamate | SUSPENSION;ORAL | 211333-001 | May 31, 2019 | AB | RX | No | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Taro | FELBAMATE | felbamate | SUSPENSION;ORAL | 206314-001 | Jun 16, 2017 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Mylan Speciality Lp | FELBATOL | felbamate | SUSPENSION;ORAL | 020189-003 | Jul 29, 1993 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 felbamate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | FELBATOL | felbamate | TABLET;ORAL | 020189-002 | Jul 29, 1993 | ⤷ Start Trial | ⤷ Start Trial |
| Mylan Speciality Lp | FELBATOL | felbamate | SUSPENSION;ORAL | 020189-003 | Jul 29, 1993 | ⤷ Start Trial | ⤷ Start Trial |
| Mylan Speciality Lp | FELBATOL | felbamate | TABLET;ORAL | 020189-001 | Jul 29, 1993 | ⤷ Start Trial | ⤷ Start Trial |
| Mylan Speciality Lp | FELBATOL | felbamate | TABLET;ORAL | 020189-001 | Jul 29, 1993 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
