VEKLURY — FDA application NDA214787
Listed sponsor: GILEAD SCIENCES INC · GILD company profile · exact_unique
Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.
FDA application facts
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | VEKLURY | REMDESIVIR | POWDER | INTRAVENOUS | 100MG/VIAL | Prescription | not listed | Yes |
| 002 | VEKLURY | REMDESIVIR | SOLUTION | INTRAVENOUS | 100MG/20ML (5MG/ML) | Discontinued | not listed | Yes |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 8318682 | 001 | listed patent expiry date: 2029-04-22 | drug substance, drug product |
| Patent 8318682 | 002 | listed patent expiry date: 2029-04-22 | drug substance, drug product |
| Patent RE46762 | 001 | listed patent expiry date: 2029-04-22 | drug substance, drug product |
| Patent RE46762 | 002 | listed patent expiry date: 2029-04-22 | drug substance, drug product |
| Patent 8008264 | 001 | listed patent expiry date: 2029-09-06 | drug substance, drug product |
| Patent 8008264 | 002 | listed patent expiry date: 2029-09-06 | drug substance, drug product |
| Patent 8318682 | 001 | listed patent expiry date: 2029-10-22 | pediatric extension |
| Patent 8318682 | 002 | listed patent expiry date: 2029-10-22 | pediatric extension |
| Patent RE46762 | 001 | listed patent expiry date: 2029-10-22 | pediatric extension |
| Patent RE46762 | 002 | listed patent expiry date: 2029-10-22 | pediatric extension |
| Patent 8008264 | 001 | listed patent expiry date: 2030-03-06 | pediatric extension |
| Patent 8008264 | 002 | listed patent expiry date: 2030-03-06 | pediatric extension |
| Patent 10065958 | 001 | listed patent expiry date: 2031-09-16 | drug substance |
| Patent 10065958 | 002 | listed patent expiry date: 2031-09-16 | drug substance |
| Patent 11492353 | 001 | listed patent expiry date: 2031-12-08 | drug substance |
| Patent 11492353 | 002 | listed patent expiry date: 2031-12-08 | drug substance |
| Patent 10065958 | 001 | listed patent expiry date: 2032-03-16 | pediatric extension |
| Patent 10065958 | 002 | listed patent expiry date: 2032-03-16 | pediatric extension |
| Patent 11492353 | 001 | listed patent expiry date: 2032-06-08 | pediatric extension |
| Patent 11492353 | 002 | listed patent expiry date: 2032-06-08 | pediatric extension |
| Patent 9724360 | 001 | listed patent expiry date: 2035-10-29 | drug substance, drug product |
| Patent 9724360 | 002 | listed patent expiry date: 2035-10-29 | drug substance, drug product |
| Patent 9949994 | 001 | listed patent expiry date: 2035-10-29 | drug substance |
| Patent 9949994 | 002 | listed patent expiry date: 2035-10-29 | drug substance |
| Patent 9724360 | 001 | listed patent expiry date: 2036-04-29 | pediatric extension |
| Patent 9724360 | 002 | listed patent expiry date: 2036-04-29 | pediatric extension |
| Patent 9949994 | 001 | listed patent expiry date: 2036-04-29 | pediatric extension |
| Patent 9949994 | 002 | listed patent expiry date: 2036-04-29 | pediatric extension |
| Patent 10695361 | 001 | listed patent expiry date: 2036-09-16 | U-3831 |
| Patent 10695361 | 001 | listed patent expiry date: 2036-09-16 | U-3832 |
| Patent 10695361 | 002 | listed patent expiry date: 2036-09-16 | U-3829 |
| Patent 10695361 | 002 | listed patent expiry date: 2036-09-16 | U-3830 |
| Patent 11007208 | 001 | listed patent expiry date: 2036-09-16 | U-3831 |
| Patent 11007208 | 001 | listed patent expiry date: 2036-09-16 | U-3832 |
| Patent 11007208 | 002 | listed patent expiry date: 2036-09-16 | U-3829 |
| Patent 11007208 | 002 | listed patent expiry date: 2036-09-16 | U-3830 |
| Patent 11382926 | 001 | listed patent expiry date: 2036-09-16 | U-3831 |
| Patent 11382926 | 001 | listed patent expiry date: 2036-09-16 | U-3832 |
| Patent 11382926 | 002 | listed patent expiry date: 2036-09-16 | U-3830 |
| Patent 11382926 | 002 | listed patent expiry date: 2036-09-16 | U-3829 |
| Patent 10695361 | 001 | listed patent expiry date: 2037-03-16 | pediatric extension |
| Patent 10695361 | 002 | listed patent expiry date: 2037-03-16 | pediatric extension |
| Patent 11007208 | 001 | listed patent expiry date: 2037-03-16 | pediatric extension |
| Patent 11007208 | 002 | listed patent expiry date: 2037-03-16 | pediatric extension |
| Patent 11382926 | 001 | listed patent expiry date: 2037-03-16 | pediatric extension |
| Patent 11382926 | 002 | listed patent expiry date: 2037-03-16 | pediatric extension |
| Patent 10675296 | 001 | listed patent expiry date: 2038-07-10 | drug product |
| Patent 11266681 | 001 | listed patent expiry date: 2038-07-10 | U-3832 |
| Patent 11266681 | 001 | listed patent expiry date: 2038-07-10 | U-3831 |
| Patent 11975017 | 001 | listed patent expiry date: 2038-07-10 | drug product |
| Patent 10675296 | 001 | listed patent expiry date: 2039-01-10 | pediatric extension |
| Patent 11266681 | 001 | listed patent expiry date: 2039-01-10 | pediatric extension |
| Patent 11975017 | 001 | listed patent expiry date: 2039-01-10 | pediatric extension |
| Patent 11491169 | 001 | listed patent expiry date: 2041-05-28 | U-3836 |
| Patent 11491169 | 001 | listed patent expiry date: 2041-05-28 | U-3835 |
| Patent 11491169 | 002 | listed patent expiry date: 2041-05-28 | U-3834 |
| Patent 11491169 | 002 | listed patent expiry date: 2041-05-28 | U-3833 |
| Patent 11903953 | 001 | listed patent expiry date: 2041-05-28 | U-3835 |
| Patent 11903953 | 001 | listed patent expiry date: 2041-05-28 | U-3836 |
| Patent 11903953 | 002 | listed patent expiry date: 2041-05-28 | U-3833 |
| Patent 11903953 | 002 | listed patent expiry date: 2041-05-28 | U-3834 |
| Patent 11975012 | 001 | listed patent expiry date: 2041-05-28 | U-3835 |
| Patent 11975012 | 001 | listed patent expiry date: 2041-05-28 | U-3836 |
| Patent 11975012 | 002 | listed patent expiry date: 2041-05-28 | U-3833 |
| Patent 11975012 | 002 | listed patent expiry date: 2041-05-28 | U-3834 |
| Patent 11491169 | 001 | listed patent expiry date: 2041-11-28 | pediatric extension |
| Patent 11491169 | 002 | listed patent expiry date: 2041-11-28 | pediatric extension |
| Patent 11903953 | 001 | listed patent expiry date: 2041-11-28 | pediatric extension |
| Patent 11903953 | 002 | listed patent expiry date: 2041-11-28 | pediatric extension |
| Patent 11975012 | 001 | listed patent expiry date: 2041-11-28 | pediatric extension |
| Patent 11975012 | 002 | listed patent expiry date: 2041-11-28 | pediatric extension |
| Exclusivity NCE | 001 | listed exclusivity date: 2025-10-22 | FDA code as listed |
| Exclusivity NCE | 002 | listed exclusivity date: 2025-10-22 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2026-04-22 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2026-04-22 | FDA code as listed |
| Exclusivity M-301 | 001 | listed exclusivity date: 2026-07-13 | FDA code as listed |
| Exclusivity M-301 | 002 | listed exclusivity date: 2026-07-13 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2027-01-13 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2027-01-13 | FDA code as listed |
Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.
Compound cross-links
- REMDESIVIR · UNII 3QKI37EEHE · lmmol compound RWWYLEGWBNMMLJ-YSOARWBDSA-N · CHEMBL4065616
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: Large-cap biopharma
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.