Details for New Drug Application (NDA): 214187
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NDA 214187 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 214187
| Tradename: | EPCLUSA |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | sofosbuvir; velpatasvir |
| Patents: | 14 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214187
Generic Entry Date for 214187*:
Constraining patent/regulatory exclusivity:
Dosage:
PELLETS;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: 214187
Suppliers and Packaging for NDA: 214187
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EPCLUSA | sofosbuvir; velpatasvir | PELLETS;ORAL | 214187 | NDA | Gilead Sciences, Inc. | 61958-2204 | 61958-2204-1 | 28 PACKET in 1 CARTON (61958-2204-1) / 1 PELLET in 1 PACKET |
| EPCLUSA | sofosbuvir; velpatasvir | PELLETS;ORAL | 214187 | NDA | Gilead Sciences, Inc. | 61958-2205 | 61958-2205-1 | 28 PACKET in 1 CARTON (61958-2205-1) / 1 PELLET in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | PELLETS;ORAL | Strength | 150MG;37.5MG/PACKET | ||||
| Approval Date: | Jun 10, 2021 | 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: | Dec 10, 2028 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| 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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