FDA Orange Book
Is there a generic for Sovaldi?
Sovaldi contains sofosbuvir. 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 Sovaldi (sofosbuvir). The Orange Book shows its last listed patent expires June 11, 2031 and its last listed exclusivity ends August 28, 2026.
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Sovaldi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| pellets, oral | 150MG/PACKET | Marketed (Rx) | None | 0 | None |
| pellets, oral | 200MG/PACKET | Marketed (Rx) | None | 0 | None |
| tablet, oral | 200MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 400MG | Marketed (Rx) | None | 0 | None |
NDA 212480, 204671, 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.
Sovaldi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8334270 | March 21, 2028 | Drug substance, Drug product | U-1470 | 212480 |
| 8580765 | March 21, 2028 | Drug substance, Drug product | U-1470 | 212480 |
| 9085573 | March 21, 2028 | Drug substance, Drug product | U-1470 | 212480 |
| 8334270*PED | September 21, 2028 | Method of use | None | 212480 |
| 8580765*PED | September 21, 2028 | Method of use | None | 212480 |
| 9085573*PED | September 21, 2028 | Method of use | None | 212480 |
| 7964580 | March 26, 2029 | Drug substance, Drug product | U-1470 | 212480 |
| 8633309 | March 26, 2029 | Drug substance, Drug product | U-1470 | 212480 |
| 8889159 | March 26, 2029 | Drug product | U-1470 | 212480 |
| 9549941 | March 26, 2029 | Method of use | U-1958 | 204671 |
| 7964580*PED | September 26, 2029 | Method of use | None | 212480 |
| 8633309*PED | September 26, 2029 | Method of use | None | 212480 |
| 8889159*PED | September 26, 2029 | Method of use | None | 212480 |
| 9549941*PED | September 26, 2029 | Method of use | None | 204671 |
| 9284342 | September 13, 2030 | Drug substance, Drug product | U-1470 | 212480 |
| 8618076 | December 11, 2030 | Drug substance, Drug product | U-1470 | 212480 |
| 9284342*PED | March 13, 2031 | Method of use | None | 212480 |
| 8618076*PED | June 11, 2031 | Method of use | None | 212480 |
Sovaldi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-258 | Orphan drug exclusivity | August 28, 2026 | 212480 |
| ODE* | See the Orange Book exclusivity code list | August 28, 2026 | 204671 |
Sovaldi NDC codes
Questions
Is there a generic for Sovaldi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sovaldi (sofosbuvir). The Orange Book shows its last listed patent expires June 11, 2031 and its last listed exclusivity ends August 28, 2026.
What is the generic name for Sovaldi?
The active ingredient in Sovaldi is sofosbuvir, per the FDA Orange Book.
When does the Sovaldi patent expire?
The last patent listed for Sovaldi in the Orange Book expires June 11, 2031. 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.