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Last Updated: January 24, 2021

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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.
Summary for 208277
Applicant:Eisai Inc
Generic Entry Opportunity Date for 208277
Generic Entry Date for 208277*:
Constraining patent/regulatory exclusivity:

*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 ActionAMPA 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:RXDosage:SUSPENSION;ORALStrength0.5MG/ML
Approval Date:Apr 29, 2016TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 8, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Jul 1, 2026Product Flag?Substance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

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