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.
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
*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
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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