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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 202834


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NDA 202834 describes FYCOMPA, which is a drug marketed by Catalyst Pharms and is included in two NDAs. It is available from two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the perampanel profile page.
Summary for 202834
Tradename:FYCOMPA
Applicant:Catalyst Pharms
Ingredient:perampanel
Patents:2
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202834
Generic Entry Date for 202834*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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.

Suppliers and Packaging for NDA: 202834
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FYCOMPA perampanel TABLET;ORAL 202834 NDA Eisai Inc. 62856-272 62856-272-14 14 TABLET in 1 PACKET (62856-272-14)
FYCOMPA perampanel TABLET;ORAL 202834 NDA Eisai Inc. 62856-272 62856-272-30 30 TABLET in 1 BOTTLE (62856-272-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Oct 22, 2012TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jun 8, 2024Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF EPILEPSY
Patent:⤷  Try a TrialPatent Expiration:Jun 8, 2024Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PARTIAL-ONSET SEIZURES WITH OR WITHOUT SECONDARILY GENERALIZED SEIZURES IN PATIENTS WITH EPILEPSY
Patent:⤷  Try a TrialPatent Expiration:Jun 8, 2024Product Flag?YSubstance Flag?YDelist 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.