DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 208277
NDA 208277 describes FYCOMPA, which is a drug marketed by Eisai Inc and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FYCOMPA profile page.
The generic ingredient in FYCOMPA is perampanel. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the perampanel profile page.
The generic ingredient in FYCOMPA is perampanel. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the perampanel profile page.
Summary for 208277
| Tradename: | FYCOMPA |
| Applicant: | Eisai Inc |
| Ingredient: | perampanel |
| Patents: | 2 |
Pharmacology for NDA: 208277
| Mechanism of Action | AMPA Receptor Antagonists |
Suppliers and Packaging for NDA: 208277
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FYCOMPA | perampanel | SUSPENSION;ORAL | 208277 | NDA | Eisai Inc. | 62856-290 | N | 62856-290-38 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 0.5MG/ML | ||||
| Approval Date: | Apr 29, 2016 | TE: | RLD: | Yes | |||||
| Patent: | ➤ Sign Up | Patent Expiration: | Jun 8, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF EPILEPSY | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Jun 8, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PARTIAL-ONSET SEIZURES WITH OR WITHOUT SECONDARILY GENERALIZED SEIZURES IN PATIENTS WITH EPILEPSY | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Jun 8, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY | ||||||||
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