Assyro AI

Orange Book product · Brand (NDA)

EPCLUSA

SOFOSBUVIR; VELPATASVIR

Brand (NDA)NDA 214187RX GILEAD SCIENCES INC
View SOFOSBUVIR; VELPATASVIR familyOpen on FDA Orange Book

At a glance

Jun 10, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

28

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 10, 2021

    5 yr 1 mo ago

  2. Today

  3. Exclusivity ends · ODE*

    FDA marketing exclusivity

    Mar 19, 2027

    in 9 mo

  4. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Sep 19, 2027

    in 1 yr 3 mo

  5. Patent 8334270 expires

    Listed drug substance patent expiration.

    Mar 21, 2028

    in 1 yr 9 mo

  6. Patent 8580765 expires

    Listed drug substance patent expiration.

    Mar 21, 2028

    in 1 yr 9 mo

  7. Patent 8735372 expires

    Listed method-of-use patent (U-1470) expiration.

    Mar 21, 2028

    in 1 yr 9 mo

  8. Patent 9085573 expires

    Listed drug substance patent expiration.

    Mar 21, 2028

    in 1 yr 9 mo

  9. Patent 8334270*PED expires

    Listed listed patent expiration.

    Sep 21, 2028

    in 2 yr 4 mo

  10. Patent 8580765*PED expires

    Listed listed patent expiration.

    Sep 21, 2028

    in 2 yr 4 mo

  11. Patent 8735372*PED expires

    Listed listed patent expiration.

    Sep 21, 2028

    in 2 yr 4 mo

  12. Patent 9085573*PED expires

    Listed listed patent expiration.

    Sep 21, 2028

    in 2 yr 4 mo

  13. Patent 7964580 expires

    Listed drug substance patent expiration.

    Mar 26, 2029

    in 2 yr 10 mo

  14. Patent 8633309 expires

    Listed drug substance patent expiration.

    Mar 26, 2029

    in 2 yr 10 mo

  15. Patent 8889159 expires

    Listed drug product patent expiration.

    Mar 26, 2029

    in 2 yr 10 mo

  16. Patent 7964580*PED expires

    Listed listed patent expiration.

    Sep 26, 2029

    in 3 yr 4 mo

  17. Patent 8633309*PED expires

    Listed listed patent expiration.

    Sep 26, 2029

    in 3 yr 4 mo

  18. Patent 8889159*PED expires

    Listed listed patent expiration.

    Sep 26, 2029

    in 3 yr 4 mo

  19. Patent 9284342 expires

    Listed drug substance patent expiration.

    Sep 13, 2030

    in 4 yr 4 mo

  20. Patent 8618076 expires

    Listed drug substance patent expiration.

    Dec 11, 2030

    in 4 yr 7 mo

  21. Patent 9284342*PED expires

    Listed listed patent expiration.

    Mar 13, 2031

    in 4 yr 10 mo

  22. Patent 8618076*PED expires

    Listed listed patent expiration.

    Jun 11, 2031

    in 5 yr 1 mo

  23. Patent 8575135 expires

    Listed drug substance patent expiration.

    Nov 16, 2032

    in 6 yr 6 mo

  24. Patent 8921341 expires

    Listed drug substance patent expiration.

    Nov 16, 2032

    in 6 yr 6 mo

  25. Patent 8940718 expires

    Listed drug substance patent expiration.

    Nov 16, 2032

    in 6 yr 6 mo

  26. Patent 8575135*PED expires

    Listed listed patent expiration.

    May 16, 2033

    in 7 yr

  27. Patent 8921341*PED expires

    Listed listed patent expiration.

    May 16, 2033

    in 7 yr

  28. Patent 8940718*PED expires

    Listed listed patent expiration.

    May 16, 2033

    in 7 yr

  29. Patent 11116783 expires

    Listed drug product patent expiration.

    Jan 30, 2034

    in 7 yr 9 mo

  30. Patent 11707479 expires

    Listed drug product patent expiration.

    Jan 30, 2034

    in 7 yr 9 mo

  31. Patent 11116783*PED expires

    Listed listed patent expiration.

    Jul 30, 2034

    in 8 yr 3 mo

  32. Patent 11707479*PED expires

    Listed listed patent expiration.

    Jul 30, 2034

    in 8 yr 3 mo

Pharmaceutical detail

Active ingredient

SOFOSBUVIR; VELPATASVIR

Strength

200MG;50MG/PACKET

Dosage form

PELLETS

Route

ORAL

TE code

Not listed

Application

NDA 214187

Product number

002

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 (2)

  • ODE*FDA marketing exclusivity

    Mar 19, 2027

    in 9 mo

  • PEDPediatric exclusivity (adds 6 months)

    Sep 19, 2027

    in 1 yr 3 mo

Listed patents (28)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8334270Mar 21, 2028in 1 yr 9 mo
SubstanceProductU-1470
8580765Mar 21, 2028in 1 yr 9 mo
SubstanceProductU-1470
8735372Mar 21, 2028in 1 yr 9 mo
U-1470
9085573Mar 21, 2028in 1 yr 9 mo
SubstanceProductU-1470
8334270*PEDSep 21, 2028in 2 yr 4 mo
8580765*PEDSep 21, 2028in 2 yr 4 mo
8735372*PEDSep 21, 2028in 2 yr 4 mo
9085573*PEDSep 21, 2028in 2 yr 4 mo
7964580Mar 26, 2029in 2 yr 10 mo
SubstanceProductU-1470
8633309Mar 26, 2029in 2 yr 10 mo
SubstanceProductU-1470
8889159Mar 26, 2029in 2 yr 10 mo
ProductU-1470
7964580*PEDSep 26, 2029in 3 yr 4 mo
8633309*PEDSep 26, 2029in 3 yr 4 mo
8889159*PEDSep 26, 2029in 3 yr 4 mo
9284342Sep 13, 2030in 4 yr 4 mo
SubstanceProductU-1470
8618076Dec 11, 2030in 4 yr 7 mo
SubstanceProductU-1470
9284342*PEDMar 13, 2031in 4 yr 10 mo
8618076*PEDJun 11, 2031in 5 yr 1 mo
8575135Nov 16, 2032in 6 yr 6 mo
SubstanceProductU-1470
8921341Nov 16, 2032in 6 yr 6 mo
SubstanceProductU-1470
8940718Nov 16, 2032in 6 yr 6 mo
SubstanceProductU-1470
8575135*PEDMay 16, 2033in 7 yr
8921341*PEDMay 16, 2033in 7 yr
8940718*PEDMay 16, 2033in 7 yr
11116783Jan 30, 2034in 7 yr 9 mo
ProductU-1470
11707479Jan 30, 2034in 7 yr 9 mo
ProductU-1470
11116783*PEDJul 30, 2034in 8 yr 3 mo
11707479*PEDJul 30, 2034in 8 yr 3 mo
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