Details for New Drug Application (NDA): 208341

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

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.

Pharmacology for NDA: 208341

Mechanism of Action

Breast Cancer Resistance Protein Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Organic Anion Transporting Polypeptide 2B1 Inhibitors P-Glycoprotein Inhibitors RNA Replicase Inhibitors

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:	RX	Dosage:	TABLET;ORAL			Strength	400MG;100MG
Approval Date:	Jun 28, 2016	TE:		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:	Jul 14, 2023
Regulatory Exclusivity Use:	INFORMATION ADDED TO THE LABELING DESCRIBING A PHASE 2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY/EFFICACY OF SOFOSBUVIR/VELPATASVIR IN SUBJECTS WITH CHRONIC HCV INFECTION WHO HAVE RECEIVED A LIVER TRANSPLANT
Regulatory Exclusivity Expiration:	Dec 10, 2028
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY

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