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Last Updated: October 17, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208341

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NDA 208341 describes EPCLUSA, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from two suppliers. There are fourteen patents protecting this drug. Additional details are available on the EPCLUSA profile page.

The generic ingredient in EPCLUSA is sofosbuvir; velpatasvir. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sofosbuvir; velpatasvir profile page.
Summary for 208341
Tradename:EPCLUSA
Applicant:Gilead Sciences Inc
Ingredient:sofosbuvir; velpatasvir
Patents:14
Generic Entry Opportunity Date for 208341
Generic Entry Date for 208341*:
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: 208341
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341 NDA Gilead Sciences, Inc. 61958-2201 61958-2201-1 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-2201-1)
EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341 NDA AUTHORIZED GENERIC Asegua Therapeutics LLC 72626-2701 72626-2701-1 2 BLISTER PACK in 1 CARTON (72626-2701-1) > 14 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG;100MG
Approval Date:Jun 28, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 28, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Aug 1, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:  Start TrialPatent Expiration:Jan 30, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:FOR THE TREATMENT OF HEPATITIS C

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