FDA Orange Book
Is there a generic for Veklury?
Veklury contains remdesivir. 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 Veklury (remdesivir). The Orange Book shows its last listed patent expires November 28, 2041 and its last listed exclusivity ends August 28, 2027.
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Veklury products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 100MG/VIAL | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 100MG/20ML (5MG/ML) | Discontinued | None | 0 | None |
NDA 214787, 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.
Veklury patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8318682 | April 22, 2029 | Drug substance, Drug product | None | 214787 |
| RE46762 | April 22, 2029 | Drug substance, Drug product | None | 214787 |
| 8008264 | September 6, 2029 | Drug substance, Drug product | None | 214787 |
| 8318682*PED | October 22, 2029 | Method of use | None | 214787 |
| RE46762*PED | October 22, 2029 | Method of use | None | 214787 |
| 8008264*PED | March 6, 2030 | Method of use | None | 214787 |
| 11492353 | December 8, 2031 | Drug substance | None | 214787 |
| 11492353*PED | June 8, 2032 | Method of use | None | 214787 |
| 10065958 | November 18, 2032 | Drug substance | None | 214787 |
| 10065958*PED | May 18, 2033 | Method of use | None | 214787 |
| 9724360 | October 29, 2035 | Drug substance, Drug product | None | 214787 |
| 9949994 | October 29, 2035 | Drug substance | None | 214787 |
| 9949994*PED | April 29, 2036 | Method of use | None | 214787 |
| 9724360*PED | April 29, 2036 | Method of use | None | 214787 |
| 11382926 | September 16, 2036 | Method of use | U-3831 | 214787 |
| 11382926 | September 16, 2036 | Method of use | U-3832 | 214787 |
| 10695361 | September 16, 2036 | Method of use | U-3831 | 214787 |
| 10695361 | September 16, 2036 | Method of use | U-3832 | 214787 |
| 11007208 | September 16, 2036 | Method of use | U-3831 | 214787 |
| 11007208 | September 16, 2036 | Method of use | U-3832 | 214787 |
| 11007208 | September 16, 2036 | Method of use | U-3829 | 214787 |
| 11007208 | September 16, 2036 | Method of use | U-3830 | 214787 |
| 11382926 | September 16, 2036 | Method of use | U-3830 | 214787 |
| 11382926 | September 16, 2036 | Method of use | U-3829 | 214787 |
| 10695361 | September 16, 2036 | Method of use | U-3829 | 214787 |
| 10695361 | September 16, 2036 | Method of use | U-3830 | 214787 |
| 11007208*PED | March 16, 2037 | Method of use | None | 214787 |
| 11382926*PED | March 16, 2037 | Method of use | None | 214787 |
| 10695361*PED | March 16, 2037 | Method of use | None | 214787 |
| 11266681 | July 10, 2038 | Method of use | U-3832 | 214787 |
| 11266681 | July 10, 2038 | Method of use | U-3831 | 214787 |
| 11975017 | July 10, 2038 | Drug product | None | 214787 |
| 10675296 | July 10, 2038 | Drug product | None | 214787 |
| 10675296*PED | January 10, 2039 | Method of use | None | 214787 |
| 11266681*PED | January 10, 2039 | Method of use | None | 214787 |
| 11975017*PED | January 10, 2039 | Method of use | None | 214787 |
| 11975012 | May 28, 2041 | Method of use | U-3835 | 214787 |
| 11975012 | May 28, 2041 | Method of use | U-3836 | 214787 |
| 11491169 | May 28, 2041 | Method of use | U-3836 | 214787 |
| 11491169 | May 28, 2041 | Method of use | U-3835 | 214787 |
| 11903953 | May 28, 2041 | Method of use | U-3835 | 214787 |
| 11903953 | May 28, 2041 | Method of use | U-3836 | 214787 |
| 11975012 | May 28, 2041 | Method of use | U-3833 | 214787 |
| 11975012 | May 28, 2041 | Method of use | U-3834 | 214787 |
| 11903953 | May 28, 2041 | Method of use | U-3833 | 214787 |
| 11903953 | May 28, 2041 | Method of use | U-3834 | 214787 |
| 11491169 | May 28, 2041 | Method of use | U-3834 | 214787 |
| 11491169 | May 28, 2041 | Method of use | U-3833 | 214787 |
| 11491169*PED | November 28, 2041 | Method of use | None | 214787 |
| 11903953*PED | November 28, 2041 | Method of use | None | 214787 |
| 11975012*PED | November 28, 2041 | Method of use | None | 214787 |
Veklury exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | October 22, 2025 | 214787 |
| PED | Pediatric exclusivity | April 22, 2026 | 214787 |
| M-301 | Miscellaneous | July 13, 2026 | 214787 |
| PED | Pediatric exclusivity | January 13, 2027 | 214787 |
| NPP | New patient population | February 28, 2027 | 214787 |
| PED | Pediatric exclusivity | August 28, 2027 | 214787 |
Veklury NDC codes
Questions
Is there a generic for Veklury?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Veklury (remdesivir). The Orange Book shows its last listed patent expires November 28, 2041 and its last listed exclusivity ends August 28, 2027.
What is the generic name for Veklury?
The active ingredient in Veklury is remdesivir, per the FDA Orange Book.
When does the Veklury patent expire?
The last patent listed for Veklury in the Orange Book expires November 28, 2041. 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.