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
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.
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: | Sep 19, 2027 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Mar 19, 2027 | ||||||||
| Regulatory Exclusivity Use: | TX OF PED PTS 6 YRS OF AGE & OLDER OR WEIGHING AT LEAST 17 KG WITH CHRONIC HEPATITIS C VIRUS 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: | Apr 27, 2025 | ||||||||
| Regulatory Exclusivity Use: | UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER | ||||||||
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