Details for New Drug Application (NDA): 209195
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The generic ingredient in VOSEVI is sofosbuvir; velpatasvir; voxilaprevir. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir; velpatasvir; voxilaprevir profile page.
Summary for 209195
Tradename: | VOSEVI |
Applicant: | Gilead Sciences Inc |
Ingredient: | sofosbuvir; velpatasvir; voxilaprevir |
Patents: | 18 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209195
Generic Entry Date for 209195*:
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: 209195
Suppliers and Packaging for NDA: 209195
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VOSEVI | sofosbuvir; velpatasvir; voxilaprevir | TABLET;ORAL | 209195 | NDA | Gilead Sciences, Inc. | 61958-2401 | 61958-2401-1 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-2401-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 400MG;100MG;100MG | ||||
Approval Date: | Jul 18, 2017 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 1, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 30, 2034 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 1, 2037 | Product Flag? | Substance Flag? | Delist Request? | Y |
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