FDA Orange Book
Is there a generic for Epclusa?
Epclusa contains velpatasvir 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 Epclusa (velpatasvir and sofosbuvir). The Orange Book shows its last listed patent expires July 30, 2034 and its last listed exclusivity ends December 10, 2028.
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Epclusa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| pellets, oral | 150MG/PACKET;37.5MG/PACKET | Marketed (Rx) | None | 0 | None |
| pellets, oral | 200MG/PACKET;50MG/PACKET | Marketed (Rx) | None | 0 | None |
| tablet, oral | 200MG;50MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 400MG;100MG | Marketed (Rx) | None | 0 | None |
NDA 214187, 208341, 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.
Epclusa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8580765 | March 21, 2028 | Drug substance, Drug product | U-1470 | 214187 |
| 8334270 | March 21, 2028 | Drug substance, Drug product | U-1470 | 214187 |
| 8735372 | March 21, 2028 | Method of use | U-1470 | 214187 |
| 9085573 | March 21, 2028 | Drug substance, Drug product | U-1470 | 214187 |
| 8334270*PED | September 21, 2028 | Method of use | None | 214187 |
| 8580765*PED | September 21, 2028 | Method of use | None | 214187 |
| 8735372*PED | September 21, 2028 | Method of use | None | 214187 |
| 9085573*PED | September 21, 2028 | Method of use | None | 214187 |
| 7964580 | March 26, 2029 | Drug substance, Drug product | U-1470 | 214187 |
| 8889159 | March 26, 2029 | Drug product | U-1470 | 214187 |
| 8633309 | March 26, 2029 | Drug substance, Drug product | U-1470 | 214187 |
| 7964580*PED | September 26, 2029 | Method of use | None | 214187 |
| 8889159*PED | September 26, 2029 | Method of use | None | 214187 |
| 8633309*PED | September 26, 2029 | Method of use | None | 214187 |
| 9284342 | September 13, 2030 | Drug substance, Drug product | U-1470 | 214187 |
| 8618076 | December 11, 2030 | Drug substance, Drug product | U-1470 | 214187 |
| 9284342*PED | March 13, 2031 | Method of use | None | 214187 |
| 8618076*PED | June 11, 2031 | Method of use | None | 214187 |
| 8575135 | November 16, 2032 | Drug substance, Drug product | U-1470 | 214187 |
| 8921341 | November 16, 2032 | Drug substance, Drug product | U-1470 | 214187 |
| 8940718 | November 16, 2032 | Drug substance, Drug product | U-1470 | 214187 |
| 8575135*PED | May 16, 2033 | Method of use | None | 214187 |
| 8921341*PED | May 16, 2033 | Method of use | None | 214187 |
| 8940718*PED | May 16, 2033 | Method of use | None | 214187 |
| 11116783 | January 30, 2034 | Drug product | U-1470 | 214187 |
| 11707479 | January 30, 2034 | Drug product | U-1470 | 214187 |
| 10086011 | January 30, 2034 | Method of use | U-1470 | 208341 |
| 9757406 | January 30, 2034 | Drug product | None | 208341 |
| 11116783*PED | July 30, 2034 | Method of use | None | 214187 |
| 11707479*PED | July 30, 2034 | Method of use | None | 214187 |
| 10086011*PED | July 30, 2034 | Method of use | None | 208341 |
| 9757406*PED | July 30, 2034 | Method of use | None | 208341 |
Epclusa exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE* | See the Orange Book exclusivity code list | March 19, 2027 | 214187 |
| ODE-293 | Orphan drug exclusivity | March 19, 2027 | 208341 |
| PED | Pediatric exclusivity | September 19, 2027 | 214187 |
| ODE-376 | Orphan drug exclusivity | June 10, 2028 | 214187 |
| PED | Pediatric exclusivity | December 10, 2028 | 214187 |
Epclusa NDC codes
Questions
Is there a generic for Epclusa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Epclusa (velpatasvir and sofosbuvir). The Orange Book shows its last listed patent expires July 30, 2034 and its last listed exclusivity ends December 10, 2028.
What is the generic name for Epclusa?
The active ingredient in Epclusa is velpatasvir and sofosbuvir, per the FDA Orange Book.
When does the Epclusa patent expire?
The last patent listed for Epclusa 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.
More on Epclusa and Velpatasvir and Sofosbuvir
- What is Epclusa used for?FDA label uses
- Is Epclusa a controlled substance?Federal schedule
- Is Velpatasvir and Sofosbuvir a controlled substance?Federal schedule
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