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Serving leading biopharmaceutical companies globally:

Merck
Colorcon
US Army
US Department of Justice
McKesson
Chubb
Novartis
Express Scripts
Covington
Queensland Health

Generated: November 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202834

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NDA 202834 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 202834

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:2

Pharmacology for NDA: 202834

Mechanism of ActionAMPA Receptor Antagonists

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 62856-272-30 30 TABLET in 1 BOTTLE (62856-272-30)
FYCOMPA
perampanel
TABLET;ORAL 202834 NDA Eisai Inc. 62856-272 62856-272-90 90 TABLET in 1 BOTTLE (62856-272-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Oct 22, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 19, 2018
Regulatory Exclusivity Use:ADJUNCTIVE THERAPY FOR THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC (PG TC) SEIZURES IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE OR OLDER.
Regulatory Exclusivity Expiration:Oct 22, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:► SubscribePatent Expiration:Jun 8, 2021Product Flag?YSubstance Flag?YDelist Request?


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Serving leading biopharmaceutical companies globally:

Fuji
Colorcon
Healthtrust
Harvard Business School
Express Scripts
Chinese Patent Office
Baxter
Deloitte
Medtronic
Queensland Health

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 verifification 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.

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