FDA Orange Book
Is there a generic for Harvoni?
Harvoni contains ledipasvir and 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 Harvoni (ledipasvir and sofosbuvir). The Orange Book shows its last listed patent expires July 30, 2034 and its last listed exclusivity ends August 28, 2026.
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Harvoni products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| pellets, oral | 33.75MG/PACKET;150MG/PACKET | Marketed (Rx) | None | 0 | None |
| pellets, oral | 45MG/PACKET;200MG/PACKET | Marketed (Rx) | None | 0 | None |
| tablet, oral | 45MG;200MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 90MG;400MG | Marketed (Rx) | None | 0 | None |
NDA 212477, 205834, 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.
Harvoni patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8580765 | March 21, 2028 | Drug substance, Drug product | U-1470 | 212477 |
| 8334270 | March 21, 2028 | Drug substance, Drug product | U-1470 | 212477 |
| 8735372 | March 21, 2028 | Method of use | U-1470 | 212477 |
| 9085573 | March 21, 2028 | Drug substance, Drug product | U-1470 | 212477 |
| 8580765*PED | September 21, 2028 | Method of use | None | 212477 |
| 8334270*PED | September 21, 2028 | Method of use | None | 212477 |
| 8735372*PED | September 21, 2028 | Method of use | None | 212477 |
| 9085573*PED | September 21, 2028 | Method of use | None | 212477 |
| 7964580 | March 26, 2029 | Drug substance, Drug product | U-1470 | 212477 |
| 8633309 | March 26, 2029 | Drug substance, Drug product | U-1470 | 212477 |
| 8889159 | March 26, 2029 | Drug product | U-1470 | 212477 |
| 7964580*PED | September 26, 2029 | Method of use | None | 212477 |
| 8633309*PED | September 26, 2029 | Method of use | None | 212477 |
| 8889159*PED | September 26, 2029 | Method of use | None | 212477 |
| 8273341 | May 12, 2030 | Method of use | U-1470 | 212477 |
| 8822430 | May 12, 2030 | Drug substance, Drug product | U-1470 | 212477 |
| 8841278 | May 12, 2030 | Drug product | U-1470 | 212477 |
| 9511056 | May 12, 2030 | Method of use | U-1470 | 212477 |
| 8088368 | May 12, 2030 | Drug substance, Drug product | None | 212477 |
| 9284342 | September 13, 2030 | Drug substance, Drug product | U-1470 | 212477 |
| 8273341*PED | November 12, 2030 | Method of use | None | 212477 |
| 8088368*PED | November 12, 2030 | Method of use | None | 212477 |
| 8822430*PED | November 12, 2030 | Method of use | None | 212477 |
| 8841278*PED | November 12, 2030 | Method of use | None | 212477 |
| 9511056*PED | November 12, 2030 | Method of use | None | 212477 |
| 8618076 | December 11, 2030 | Drug substance, Drug product | U-1470 | 212477 |
| 9284342*PED | March 13, 2031 | Method of use | None | 212477 |
| 8618076*PED | June 11, 2031 | Method of use | None | 212477 |
| 9393256 | September 14, 2032 | Method of use | U-1470 | 212477 |
| 10456414 | September 14, 2032 | Drug product | None | 212477 |
| 9393256*PED | March 14, 2033 | Method of use | None | 212477 |
| 10039779 | January 30, 2034 | Drug substance, Drug product | U-1470 | 205834 |
| 10039779 | January 30, 2034 | Drug substance, Drug product | U-2369 | 205834 |
| 10039779 | January 30, 2034 | Drug substance, Drug product | U-2370 | 205834 |
| 10039779*PED | July 30, 2034 | Method of use | None | 205834 |
Harvoni exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-262 | Orphan drug exclusivity | August 28, 2026 | 212477 |
| ODE-263 | Orphan drug exclusivity | August 28, 2026 | 212477 |
| ODE-264 | Orphan drug exclusivity | August 28, 2026 | 212477 |
| ODE* | See the Orange Book exclusivity code list | August 28, 2026 | 205834 |
Harvoni NDC codes
Questions
Is there a generic for Harvoni?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Harvoni (ledipasvir and sofosbuvir). The Orange Book shows its last listed patent expires July 30, 2034 and its last listed exclusivity ends August 28, 2026.
What is the generic name for Harvoni?
The active ingredient in Harvoni is ledipasvir and sofosbuvir, per the FDA Orange Book.
When does the Harvoni patent expire?
The last patent listed for Harvoni in the Orange Book expires July 30, 2034. 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.