REMDESIVIR | N214787 | GILEAD SCIENCES INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2025-07-30 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| RE46762 | Apr 22, 2029PED: Oct 22, 2029 | PED | Yes | Yes | — | — |
| 8008264 | Sep 6, 2029PED: Mar 6, 2030 | PED | Yes | Yes | — | — |
| 8318682 | Apr 22, 2029PED: Oct 22, 2029 | PED | Yes | Yes | — | — |
| 9724360 | Oct 29, 2035PED: Apr 29, 2036 | PED | Yes | Yes | — | — |
| 9949994 | Oct 29, 2035PED: Apr 29, 2036 | PED | Yes | — | — | — |
| 10065958 | Sep 16, 2031PED: Mar 16, 2032 | PED | Yes | — | — | — |
| 10675296 | Jul 10, 2038PED: Jan 10, 2039 | PED | — | Yes | — | — |
| 10695361 | Sep 16, 2036PED: Mar 16, 2037 | PED | — | — | — | |
| 11007208 | Sep 16, 2036PED: Mar 16, 2037 | PED | — | — | — | |
| 11266681 | Jul 10, 2038PED: Jan 10, 2039 | PED | — | — | — | |
| 11382926 | Sep 16, 2036PED: Mar 16, 2037 | PED | — | — | — | |
| 11491169 | May 28, 2041PED: Nov 28, 2041 | PED | — | — | — | |
| 11492353 | Dec 8, 2031PED: Jun 8, 2032 | PED | Yes | — | — | — |
| 11903953 | May 28, 2041PED: Nov 28, 2041 | PED | — | — | — | |
| 11975012 | May 28, 2041PED: Nov 28, 2041 | PED | — | — | — | |
| 11975017 | Jul 10, 2038PED: Jan 10, 2039 | PED | — | Yes | — | — |
| Code | Date | Status |
|---|---|---|
| M-301 | Jul 13, 2026 | Expired |
| NCE | Oct 22, 2025 | Expired |
| PED | Apr 22, 2026 | Expired |
| PED | Jan 13, 2027 | < 1 year |
| M-301*PEDNewly listed — daily FDA feed, not yet in monthly Orange Book edition | Jan 13, 2027 | < 1 year |
| NCE*PEDNewly listed — daily FDA feed, not yet in monthly Orange Book edition | Apr 22, 2026 | Expired |
Gilead Sciences' remdesivir (Veklury) gained new chemical entity and pediatric exclusivity protections expiring Apr 2026.
New: VEKLURY (REMDESIVIR) — exclusivity NCE*PED exp 04/22/2026
Gilead Sciences' Veklury (remdesivir) gained pediatric exclusivity with a Jan 2027 expiration date under NDA 214787.
New: VEKLURY (REMDESIVIR) — exclusivity M-301*PED exp 01/13/2027
VEKLURY (remdesivir) received pediatric exclusivity with a Mar 2027 expiration date.
New: VEKLURY (REMDESIVIR) — exclusivity M-301*PED exp 01/13/2027
Gilead Sciences received new chemical entity and pediatric exclusivity for VEKLURY (remdesivir) expiring Apr 2026 under NDA 214787.
New: VEKLURY (REMDESIVIR) — exclusivity NCE*PED exp 04/22/2026