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Last Updated: March 29, 2024

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 two NDAs. It is available from two suppliers. There are sixteen 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:15
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 Gilead Sciences, Inc. 61958-2203 61958-2203-1 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-2203-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG;100MG
Approval Date:Jun 28, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 10, 2028
Regulatory Exclusivity Use:FOR TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE TO LESS THAN 6 YEARS OF AGE WEIGHING LESS THAN 17 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION: WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS; OR WITH DECOMPENSATED CIRRHOSIS FOR USE IN COMBINATION WITH RIBAVIRIN
Regulatory Exclusivity Expiration:Dec 10, 2028
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Jan 14, 2024
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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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.