FDA Orange Book
Is there a generic for Vosevi?
Vosevi contains sofosbuvir, velpatasvir and voxilaprevir. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vosevi (sofosbuvir, velpatasvir and voxilaprevir). The Orange Book shows its last listed patent expires December 1, 2037.
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Vosevi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 400MG;100MG;100MG | Marketed (Rx) | None | 0 | None |
NDA 209195, held by GILEAD SCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vosevi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9085573 | March 21, 2028 | Drug substance, Drug product | U-2040 | 209195 |
| 9085573 | March 21, 2028 | Drug substance, Drug product | U-2039 | 209195 |
| 8334270 | March 21, 2028 | Drug substance, Drug product | U-2040 | 209195 |
| 8580765 | March 21, 2028 | Drug substance, Drug product | U-2040 | 209195 |
| 8580765 | March 21, 2028 | Drug substance, Drug product | U-2039 | 209195 |
| 8735372 | March 21, 2028 | Drug substance, Drug product | U-2040 | 209195 |
| 8334270 | March 21, 2028 | Drug substance, Drug product | U-2039 | 209195 |
| 8735372 | March 21, 2028 | Drug substance, Drug product | U-2039 | 209195 |
| 8957046 | March 21, 2028 | Method of use | U-2040 | 209195 |
| 8957046 | March 21, 2028 | Method of use | U-2039 | 209195 |
| 8580765*PED | September 21, 2028 | Method of use | None | 209195 |
| 8334270*PED | September 21, 2028 | Method of use | None | 209195 |
| 8735372*PED | September 21, 2028 | Method of use | None | 209195 |
| 9085573*PED | September 21, 2028 | Method of use | None | 209195 |
| 7964580 | March 26, 2029 | Drug substance, Drug product | U-2039 | 209195 |
| 7964580 | March 26, 2029 | Drug substance, Drug product | U-2040 | 209195 |
| 8889159 | March 26, 2029 | Drug substance, Drug product | U-2040 | 209195 |
| 8633309 | March 26, 2029 | Drug substance, Drug product | U-2039 | 209195 |
| 8889159 | March 26, 2029 | Drug substance, Drug product | U-2039 | 209195 |
| 8633309 | March 26, 2029 | Drug substance, Drug product | U-2040 | 209195 |
| 7964580*PED | September 26, 2029 | Method of use | None | 209195 |
| 8633309*PED | September 26, 2029 | Method of use | None | 209195 |
| 8889159*PED | September 26, 2029 | Method of use | None | 209195 |
| 9284342 | September 13, 2030 | Drug substance, Drug product | U-2040 | 209195 |
| 9284342 | September 13, 2030 | Drug substance, Drug product | U-2039 | 209195 |
| 8618076 | December 11, 2030 | Drug substance, Drug product | U-2040 | 209195 |
| 8618076 | December 11, 2030 | Drug substance, Drug product | U-2039 | 209195 |
| 9284342*PED | March 13, 2031 | Method of use | None | 209195 |
| 8618076*PED | June 11, 2031 | Method of use | None | 209195 |
| 8940718 | November 16, 2032 | Drug substance, Drug product | U-2039 | 209195 |
| 8575135 | November 16, 2032 | Drug substance, Drug product | U-2040 | 209195 |
| 8921341 | November 16, 2032 | Drug substance, Drug product | U-2040 | 209195 |
| 8921341 | November 16, 2032 | Drug substance, Drug product | U-2039 | 209195 |
| 8575135 | November 16, 2032 | Drug substance, Drug product | U-2039 | 209195 |
| 8940718 | November 16, 2032 | Drug substance, Drug product | U-2040 | 209195 |
| 9868745 | November 16, 2032 | Drug substance, Drug product | None | 209195 |
| 8575135*PED | May 16, 2033 | Method of use | None | 209195 |
| 8921341*PED | May 16, 2033 | Method of use | None | 209195 |
| 8940718*PED | May 16, 2033 | Method of use | None | 209195 |
| 11116783 | January 30, 2034 | Drug product | U-2039 | 209195 |
| 11116783 | January 30, 2034 | Drug product | U-2040 | 209195 |
| 9296782 | July 17, 2034 | Drug substance, Drug product | None | 209195 |
| 11116783*PED | July 30, 2034 | Method of use | None | 209195 |
| 11338007 | June 1, 2037 | Drug product | U-2039 | 209195 |
| 11338007 | June 1, 2037 | Drug product | U-2040 | 209195 |
| 10912814 | June 1, 2037 | Drug product | None | 209195 |
| 11338007*PED | December 1, 2037 | Method of use | None | 209195 |
Vosevi NDC codes
Questions
Is there a generic for Vosevi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vosevi (sofosbuvir, velpatasvir and voxilaprevir). The Orange Book shows its last listed patent expires December 1, 2037.
What is the generic name for Vosevi?
The active ingredient in Vosevi is sofosbuvir, velpatasvir and voxilaprevir, per the FDA Orange Book.
When does the Vosevi patent expire?
The last patent listed for Vosevi in the Orange Book expires December 1, 2037. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
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