Details for New Drug Application (NDA): 208277
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The generic ingredient in FYCOMPA is perampanel. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the perampanel profile page.
Summary for 208277
Tradename: | FYCOMPA |
Applicant: | Catalyst Pharms |
Ingredient: | perampanel |
Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
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) |
FYCOMPA | perampanel | SUSPENSION;ORAL | 208277 | NDA | Catalyst Pharmaceuticals, Inc. | 69616-290 | 69616-290-38 | 340 mL in 1 BOTTLE (69616-290-38) |
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: | May 23, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | TREATMENT OF EPILEPSY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 23, 2025 | 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: | May 23, 2025 | 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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