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Serving leading biopharmaceutical companies globally:

Medtronic
Julphar
US Army
QuintilesIMS
Argus Health
Dow
Chubb
Accenture
McKinsey
US Department of Justice

Generated: February 23, 2018

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 one supplier. There are thirteen 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 208341
Tradename:EPCLUSA
Applicant:Gilead Sciences Inc
Ingredient:sofosbuvir; velpatasvir
Patents:13
Formulation / Manufacturing:see details
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 N 61958-2201-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG;100MG
Approval Date:Jun 28, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 6, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jun 28, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Aug 1, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION

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Cerilliant
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Queensland Health
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Mallinckrodt
Johnson and Johnson
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UBS

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