Details for New Drug Application (NDA): 209195
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NDA 209195 describes VOSEVI, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are eighteen patents protecting this drug. Additional details are available on the VOSEVI profile page.
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.
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: | ⤷ Subscribe | Patent Expiration: | Jun 1, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Jul 30, 2034 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Dec 1, 2037 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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