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Last Updated: January 29, 2022

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 214187


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NDA 214187 describes EPCLUSA, which is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from one supplier. There are fifteen 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. One supplier is listed for this compound. Additional details are available on the sofosbuvir; velpatasvir profile page.
Summary for 214187
Tradename:EPCLUSA
Applicant:Gilead Sciences Inc
Ingredient:sofosbuvir; velpatasvir
Patents:13
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 214187
Generic Entry Date for 214187*:
Constraining patent/regulatory exclusivity:
Dosage:
PELLETS;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: 214187
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPCLUSA sofosbuvir; velpatasvir PELLETS;ORAL 214187 NDA Gilead Sciences, Inc. 61958-2204 61958-2204-1 28 PACKET in 1 CARTON (61958-2204-1) > 1 PELLET in 1 PACKET
EPCLUSA sofosbuvir; velpatasvir PELLETS;ORAL 214187 NDA Gilead Sciences, Inc. 61958-2205 61958-2205-1 28 PACKET in 1 CARTON (61958-2205-1) > 1 PELLET in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:PELLETS;ORALStrength150MG;37.5MG/PACKET
Approval Date:Jun 10, 2021TE:RLD:Yes
Patent:⤷  Try it FreePatent Expiration:Jul 30, 2034Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try it FreePatent Expiration:Sep 26, 2029Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try it FreePatent Expiration:Sep 21, 2028Product Flag?Substance Flag?Delist Request?Y

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