FDA Orange Book · active-ingredient family
Remdesivir
Remdesivir is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:VEKLURY · NDA 214787
1
Brand (NDA)
0
Generics (ANDA)
32
Listed patents
8
Exclusivity periods
Brand (NDA) products · powder, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VEKLURYRLD×2 | GILEAD SCIENCES INC | NDA 214787 | — | Oct 22, 2020 |
Marketing exclusivity (8)
- M-301New use / labeling-change exclusivity (3 years)
Jul 13, 2026
in 24 d
- NCENew chemical entity exclusivity (5 years)
Oct 22, 2025
8 mo ago
- PEDPediatric exclusivity (adds 6 months)
Apr 22, 2026
2 mo ago
- PEDPediatric exclusivity (adds 6 months)
Jan 13, 2027
in 7 mo
- M-301New use / labeling-change exclusivity (3 years)
Jul 13, 2026
in 24 d
- NCENew chemical entity exclusivity (5 years)
Oct 22, 2025
8 mo ago
- PEDPediatric exclusivity (adds 6 months)
Apr 22, 2026
2 mo ago
- PEDPediatric exclusivity (adds 6 months)
Jan 13, 2027
in 7 mo
Listed patents (32)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8318682 | Apr 22, 2029 | in 2 yr 11 mo | SubstanceProduct |
| RE46762 | Apr 22, 2029 | in 2 yr 11 mo | SubstanceProduct |
| 8008264 | Sep 06, 2029 | in 3 yr 3 mo | SubstanceProduct |
| 8318682*PED | Oct 22, 2029 | in 3 yr 5 mo | |
| RE46762*PED | Oct 22, 2029 | in 3 yr 5 mo | |
| 8008264*PED | Mar 06, 2030 | in 3 yr 9 mo | |
| 10065958 | Sep 16, 2031 | in 5 yr 4 mo | Substance |
| 11492353 | Dec 08, 2031 | in 5 yr 7 mo | Substance |
| 10065958*PED | Mar 16, 2032 | in 5 yr 10 mo | |
| 11492353*PED | Jun 08, 2032 | in 6 yr 1 mo | |
| 9724360 | Oct 29, 2035 | in 9 yr 6 mo | SubstanceProduct |
| 9949994 | Oct 29, 2035 | in 9 yr 6 mo | Substance |
| 9949994*PED | Apr 29, 2036 | in 10 yr | |
| 9724360*PED | Apr 29, 2036 | in 10 yr | |
| 11382926 | Sep 16, 2036 | in 10 yr 5 mo | U-3831 |
| 10695361 | Sep 16, 2036 | in 10 yr 5 mo | U-3831 |
| 11007208 | Sep 16, 2036 | in 10 yr 5 mo | U-3831 |
| 11007208*PED | Mar 16, 2037 | in 10 yr 11 mo | |
| 11382926*PED | Mar 16, 2037 | in 10 yr 11 mo | |
| 10695361*PED | Mar 16, 2037 | in 10 yr 11 mo | |
| 11266681 | Jul 10, 2038 | in 12 yr 3 mo | U-3832 |
| 11975017 | Jul 10, 2038 | in 12 yr 3 mo | Product |
| 10675296 | Jul 10, 2038 | in 12 yr 3 mo | Product |
| 10675296*PED | Jan 10, 2039 | in 12 yr 9 mo | |
| 11266681*PED | Jan 10, 2039 | in 12 yr 9 mo | |
| 11975017*PED | Jan 10, 2039 | in 12 yr 9 mo | |
| 11975012 | May 28, 2041 | in 15 yr 2 mo | U-3835 |
| 11491169 | May 28, 2041 | in 15 yr 2 mo | U-3836 |
| 11903953 | May 28, 2041 | in 15 yr 2 mo | U-3835 |
| 11491169*PED | Nov 28, 2041 | in 15 yr 8 mo | |
| 11903953*PED | Nov 28, 2041 | in 15 yr 8 mo | |
| 11975012*PED | Nov 28, 2041 | in 15 yr 8 mo |
Remdesivir — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
