Orange Book product · Brand (NDA)
VEKLURY
REMDESIVIR
At a glance
Oct 22, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
39
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 22, 2020
5 yr 9 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Oct 22, 2025
8 mo ago
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Apr 22, 2026
2 mo ago
Today
Exclusivity ends · M-301
New use / labeling-change exclusivity (3 years)
Jul 13, 2026
in 24 d
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Jan 13, 2027
in 7 mo
Patent 8318682 expires
Listed drug substance patent expiration.
Apr 22, 2029
in 2 yr 11 mo
Patent RE46762 expires
Listed drug substance patent expiration.
Apr 22, 2029
in 2 yr 11 mo
Patent 8008264 expires
Listed drug substance patent expiration.
Sep 06, 2029
in 3 yr 3 mo
Patent 8318682*PED expires
Listed listed patent expiration.
Oct 22, 2029
in 3 yr 5 mo
Patent RE46762*PED expires
Listed listed patent expiration.
Oct 22, 2029
in 3 yr 5 mo
Patent 8008264*PED expires
Listed listed patent expiration.
Mar 06, 2030
in 3 yr 9 mo
Patent 10065958 expires
Listed drug substance patent expiration.
Sep 16, 2031
in 5 yr 4 mo
Patent 11492353 expires
Listed drug substance patent expiration.
Dec 08, 2031
in 5 yr 7 mo
Patent 10065958*PED expires
Listed listed patent expiration.
Mar 16, 2032
in 5 yr 10 mo
Patent 11492353*PED expires
Listed listed patent expiration.
Jun 08, 2032
in 6 yr 1 mo
Patent 9724360 expires
Listed drug substance patent expiration.
Oct 29, 2035
in 9 yr 6 mo
Patent 9949994 expires
Listed drug substance patent expiration.
Oct 29, 2035
in 9 yr 6 mo
Patent 9724360*PED expires
Listed listed patent expiration.
Apr 29, 2036
in 10 yr
Patent 9949994*PED expires
Listed listed patent expiration.
Apr 29, 2036
in 10 yr
Patent 10695361 expires
Listed method-of-use patent (U-3831) expiration.
Sep 16, 2036
in 10 yr 5 mo
Patent 10695361 expires
Listed method-of-use patent (U-3832) expiration.
Sep 16, 2036
in 10 yr 5 mo
Patent 11007208 expires
Listed method-of-use patent (U-3831) expiration.
Sep 16, 2036
in 10 yr 5 mo
Patent 11007208 expires
Listed method-of-use patent (U-3832) expiration.
Sep 16, 2036
in 10 yr 5 mo
Patent 11382926 expires
Listed method-of-use patent (U-3831) expiration.
Sep 16, 2036
in 10 yr 5 mo
Patent 11382926 expires
Listed method-of-use patent (U-3832) expiration.
Sep 16, 2036
in 10 yr 5 mo
Patent 10695361*PED expires
Listed listed patent expiration.
Mar 16, 2037
in 10 yr 11 mo
Patent 11007208*PED expires
Listed listed patent expiration.
Mar 16, 2037
in 10 yr 11 mo
Patent 11382926*PED expires
Listed listed patent expiration.
Mar 16, 2037
in 10 yr 11 mo
Patent 10675296 expires
Listed drug product patent expiration.
Jul 10, 2038
in 12 yr 3 mo
Patent 11266681 expires
Listed method-of-use patent (U-3832) expiration.
Jul 10, 2038
in 12 yr 3 mo
Patent 11266681 expires
Listed method-of-use patent (U-3831) expiration.
Jul 10, 2038
in 12 yr 3 mo
Patent 11975017 expires
Listed drug product patent expiration.
Jul 10, 2038
in 12 yr 3 mo
Patent 10675296*PED expires
Listed listed patent expiration.
Jan 10, 2039
in 12 yr 9 mo
Patent 11266681*PED expires
Listed listed patent expiration.
Jan 10, 2039
in 12 yr 9 mo
Patent 11975017*PED expires
Listed listed patent expiration.
Jan 10, 2039
in 12 yr 9 mo
Patent 11491169 expires
Listed method-of-use patent (U-3836) expiration.
May 28, 2041
in 15 yr 2 mo
Patent 11491169 expires
Listed method-of-use patent (U-3835) expiration.
May 28, 2041
in 15 yr 2 mo
Patent 11903953 expires
Listed method-of-use patent (U-3835) expiration.
May 28, 2041
in 15 yr 2 mo
Patent 11903953 expires
Listed method-of-use patent (U-3836) expiration.
May 28, 2041
in 15 yr 2 mo
Patent 11975012 expires
Listed method-of-use patent (U-3835) expiration.
May 28, 2041
in 15 yr 2 mo
Patent 11975012 expires
Listed method-of-use patent (U-3836) expiration.
May 28, 2041
in 15 yr 2 mo
Patent 11491169*PED expires
Listed listed patent expiration.
Nov 28, 2041
in 15 yr 8 mo
Patent 11903953*PED expires
Listed listed patent expiration.
Nov 28, 2041
in 15 yr 8 mo
Patent 11975012*PED expires
Listed listed patent expiration.
Nov 28, 2041
in 15 yr 8 mo
Pharmaceutical detail
Active ingredient
REMDESIVIR
Strength
100MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 214787
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (4)
- NCENew chemical entity exclusivity (5 years)
Oct 22, 2025
8 mo ago
- PEDPediatric exclusivity (adds 6 months)
Apr 22, 2026
2 mo ago
- M-301New use / labeling-change exclusivity (3 years)
Jul 13, 2026
in 24 d
- PEDPediatric exclusivity (adds 6 months)
Jan 13, 2027
in 7 mo
Listed patents (39)
| 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 |
| 9724360*PED | Apr 29, 2036 | in 10 yr | |
| 9949994*PED | Apr 29, 2036 | in 10 yr | |
| 10695361 | Sep 16, 2036 | in 10 yr 5 mo | U-3831 |
| 10695361 | Sep 16, 2036 | in 10 yr 5 mo | U-3832 |
| 11007208 | Sep 16, 2036 | in 10 yr 5 mo | U-3831 |
| 11007208 | Sep 16, 2036 | in 10 yr 5 mo | U-3832 |
| 11382926 | Sep 16, 2036 | in 10 yr 5 mo | U-3831 |
| 11382926 | Sep 16, 2036 | in 10 yr 5 mo | U-3832 |
| 10695361*PED | Mar 16, 2037 | in 10 yr 11 mo | |
| 11007208*PED | Mar 16, 2037 | in 10 yr 11 mo | |
| 11382926*PED | Mar 16, 2037 | in 10 yr 11 mo | |
| 10675296 | Jul 10, 2038 | in 12 yr 3 mo | Product |
| 11266681 | Jul 10, 2038 | in 12 yr 3 mo | U-3832 |
| 11266681 | Jul 10, 2038 | in 12 yr 3 mo | U-3831 |
| 11975017 | 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 | |
| 11491169 | May 28, 2041 | in 15 yr 2 mo | U-3836 |
| 11491169 | May 28, 2041 | in 15 yr 2 mo | U-3835 |
| 11903953 | May 28, 2041 | in 15 yr 2 mo | U-3835 |
| 11903953 | May 28, 2041 | in 15 yr 2 mo | U-3836 |
| 11975012 | May 28, 2041 | in 15 yr 2 mo | U-3835 |
| 11975012 | May 28, 2041 | in 15 yr 2 mo | U-3836 |
| 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 |

