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Details for New Drug Application (NDA): 208277
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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 |
Generic Entry Opportunity Date for 208277
Generic Entry Date for 208277*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 | 62856-290-38 | 340 mL in 1 BOTTLE (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: | Start Trial | Patent Expiration: | Jun 8, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF EPILEPSY | ||||||||
| Patent: | Start Trial | 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: | Start Trial | 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 4 YEARS OF AGE AND OLDER | ||||||||
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