Assyro AI

Orange Book product · Brand (NDA)

VEKLURY

REMDESIVIR

Brand (NDA)NDA 214787RX GILEAD SCIENCES INC

At a glance

Oct 22, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

39

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 22, 2020

    5 yr 9 mo ago

  2. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Oct 22, 2025

    8 mo ago

  3. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Apr 22, 2026

    2 mo ago

  4. Today

  5. Exclusivity ends · M-301

    New use / labeling-change exclusivity (3 years)

    Jul 13, 2026

    in 24 d

  6. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Jan 13, 2027

    in 7 mo

  7. Patent 8318682 expires

    Listed drug substance patent expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  8. Patent RE46762 expires

    Listed drug substance patent expiration.

    Apr 22, 2029

    in 2 yr 11 mo

  9. Patent 8008264 expires

    Listed drug substance patent expiration.

    Sep 06, 2029

    in 3 yr 3 mo

  10. Patent 8318682*PED expires

    Listed listed patent expiration.

    Oct 22, 2029

    in 3 yr 5 mo

  11. Patent RE46762*PED expires

    Listed listed patent expiration.

    Oct 22, 2029

    in 3 yr 5 mo

  12. Patent 8008264*PED expires

    Listed listed patent expiration.

    Mar 06, 2030

    in 3 yr 9 mo

  13. Patent 10065958 expires

    Listed drug substance patent expiration.

    Sep 16, 2031

    in 5 yr 4 mo

  14. Patent 11492353 expires

    Listed drug substance patent expiration.

    Dec 08, 2031

    in 5 yr 7 mo

  15. Patent 10065958*PED expires

    Listed listed patent expiration.

    Mar 16, 2032

    in 5 yr 10 mo

  16. Patent 11492353*PED expires

    Listed listed patent expiration.

    Jun 08, 2032

    in 6 yr 1 mo

  17. Patent 9724360 expires

    Listed drug substance patent expiration.

    Oct 29, 2035

    in 9 yr 6 mo

  18. Patent 9949994 expires

    Listed drug substance patent expiration.

    Oct 29, 2035

    in 9 yr 6 mo

  19. Patent 9724360*PED expires

    Listed listed patent expiration.

    Apr 29, 2036

    in 10 yr

  20. Patent 9949994*PED expires

    Listed listed patent expiration.

    Apr 29, 2036

    in 10 yr

  21. Patent 10695361 expires

    Listed method-of-use patent (U-3831) expiration.

    Sep 16, 2036

    in 10 yr 5 mo

  22. Patent 10695361 expires

    Listed method-of-use patent (U-3832) expiration.

    Sep 16, 2036

    in 10 yr 5 mo

  23. Patent 11007208 expires

    Listed method-of-use patent (U-3831) expiration.

    Sep 16, 2036

    in 10 yr 5 mo

  24. Patent 11007208 expires

    Listed method-of-use patent (U-3832) expiration.

    Sep 16, 2036

    in 10 yr 5 mo

  25. Patent 11382926 expires

    Listed method-of-use patent (U-3831) expiration.

    Sep 16, 2036

    in 10 yr 5 mo

  26. Patent 11382926 expires

    Listed method-of-use patent (U-3832) expiration.

    Sep 16, 2036

    in 10 yr 5 mo

  27. Patent 10695361*PED expires

    Listed listed patent expiration.

    Mar 16, 2037

    in 10 yr 11 mo

  28. Patent 11007208*PED expires

    Listed listed patent expiration.

    Mar 16, 2037

    in 10 yr 11 mo

  29. Patent 11382926*PED expires

    Listed listed patent expiration.

    Mar 16, 2037

    in 10 yr 11 mo

  30. Patent 10675296 expires

    Listed drug product patent expiration.

    Jul 10, 2038

    in 12 yr 3 mo

  31. Patent 11266681 expires

    Listed method-of-use patent (U-3832) expiration.

    Jul 10, 2038

    in 12 yr 3 mo

  32. Patent 11266681 expires

    Listed method-of-use patent (U-3831) expiration.

    Jul 10, 2038

    in 12 yr 3 mo

  33. Patent 11975017 expires

    Listed drug product patent expiration.

    Jul 10, 2038

    in 12 yr 3 mo

  34. Patent 10675296*PED expires

    Listed listed patent expiration.

    Jan 10, 2039

    in 12 yr 9 mo

  35. Patent 11266681*PED expires

    Listed listed patent expiration.

    Jan 10, 2039

    in 12 yr 9 mo

  36. Patent 11975017*PED expires

    Listed listed patent expiration.

    Jan 10, 2039

    in 12 yr 9 mo

  37. Patent 11491169 expires

    Listed method-of-use patent (U-3836) expiration.

    May 28, 2041

    in 15 yr 2 mo

  38. Patent 11491169 expires

    Listed method-of-use patent (U-3835) expiration.

    May 28, 2041

    in 15 yr 2 mo

  39. Patent 11903953 expires

    Listed method-of-use patent (U-3835) expiration.

    May 28, 2041

    in 15 yr 2 mo

  40. Patent 11903953 expires

    Listed method-of-use patent (U-3836) expiration.

    May 28, 2041

    in 15 yr 2 mo

  41. Patent 11975012 expires

    Listed method-of-use patent (U-3835) expiration.

    May 28, 2041

    in 15 yr 2 mo

  42. Patent 11975012 expires

    Listed method-of-use patent (U-3836) expiration.

    May 28, 2041

    in 15 yr 2 mo

  43. Patent 11491169*PED expires

    Listed listed patent expiration.

    Nov 28, 2041

    in 15 yr 8 mo

  44. Patent 11903953*PED expires

    Listed listed patent expiration.

    Nov 28, 2041

    in 15 yr 8 mo

  45. 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 family

This 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)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8318682Apr 22, 2029in 2 yr 11 mo
SubstanceProduct
RE46762Apr 22, 2029in 2 yr 11 mo
SubstanceProduct
8008264Sep 06, 2029in 3 yr 3 mo
SubstanceProduct
8318682*PEDOct 22, 2029in 3 yr 5 mo
RE46762*PEDOct 22, 2029in 3 yr 5 mo
8008264*PEDMar 06, 2030in 3 yr 9 mo
10065958Sep 16, 2031in 5 yr 4 mo
Substance
11492353Dec 08, 2031in 5 yr 7 mo
Substance
10065958*PEDMar 16, 2032in 5 yr 10 mo
11492353*PEDJun 08, 2032in 6 yr 1 mo
9724360Oct 29, 2035in 9 yr 6 mo
SubstanceProduct
9949994Oct 29, 2035in 9 yr 6 mo
Substance
9724360*PEDApr 29, 2036in 10 yr
9949994*PEDApr 29, 2036in 10 yr
10695361Sep 16, 2036in 10 yr 5 mo
U-3831
10695361Sep 16, 2036in 10 yr 5 mo
U-3832
11007208Sep 16, 2036in 10 yr 5 mo
U-3831
11007208Sep 16, 2036in 10 yr 5 mo
U-3832
11382926Sep 16, 2036in 10 yr 5 mo
U-3831
11382926Sep 16, 2036in 10 yr 5 mo
U-3832
10695361*PEDMar 16, 2037in 10 yr 11 mo
11007208*PEDMar 16, 2037in 10 yr 11 mo
11382926*PEDMar 16, 2037in 10 yr 11 mo
10675296Jul 10, 2038in 12 yr 3 mo
Product
11266681Jul 10, 2038in 12 yr 3 mo
U-3832
11266681Jul 10, 2038in 12 yr 3 mo
U-3831
11975017Jul 10, 2038in 12 yr 3 mo
Product
10675296*PEDJan 10, 2039in 12 yr 9 mo
11266681*PEDJan 10, 2039in 12 yr 9 mo
11975017*PEDJan 10, 2039in 12 yr 9 mo
11491169May 28, 2041in 15 yr 2 mo
U-3836
11491169May 28, 2041in 15 yr 2 mo
U-3835
11903953May 28, 2041in 15 yr 2 mo
U-3835
11903953May 28, 2041in 15 yr 2 mo
U-3836
11975012May 28, 2041in 15 yr 2 mo
U-3835
11975012May 28, 2041in 15 yr 2 mo
U-3836
11491169*PEDNov 28, 2041in 15 yr 8 mo
11903953*PEDNov 28, 2041in 15 yr 8 mo
11975012*PEDNov 28, 2041in 15 yr 8 mo
Agent CTA Background

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