Assyro AI

Orange Book product · Brand (NDA)

VOSEVI

SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR

Brand (NDA)NDA 209195RX GILEAD SCIENCES INC

At a glance

Jul 18, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

47

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 18, 2017

    9 yr 1 mo ago

  2. Today

  3. Patent 8334270 expires

    Listed drug substance patent expiration.

    Mar 21, 2028

    in 1 yr 9 mo

  4. Patent 8334270 expires

    Listed drug substance patent expiration.

    Mar 21, 2028

    in 1 yr 9 mo

  5. Patent 8580765 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 drug substance patent expiration.

    Mar 21, 2028

    in 1 yr 9 mo

  8. Patent 8735372 expires

    Listed drug substance patent expiration.

    Mar 21, 2028

    in 1 yr 9 mo

  9. Patent 8957046 expires

    Listed method-of-use patent (U-2040) expiration.

    Mar 21, 2028

    in 1 yr 9 mo

  10. Patent 8957046 expires

    Listed method-of-use patent (U-2039) expiration.

    Mar 21, 2028

    in 1 yr 9 mo

  11. Patent 9085573 expires

    Listed drug substance patent expiration.

    Mar 21, 2028

    in 1 yr 9 mo

  12. Patent 9085573 expires

    Listed drug substance patent expiration.

    Mar 21, 2028

    in 1 yr 9 mo

  13. Patent 8334270*PED expires

    Listed listed patent expiration.

    Sep 21, 2028

    in 2 yr 4 mo

  14. Patent 8580765*PED expires

    Listed listed patent expiration.

    Sep 21, 2028

    in 2 yr 4 mo

  15. Patent 8735372*PED expires

    Listed listed patent expiration.

    Sep 21, 2028

    in 2 yr 4 mo

  16. Patent 9085573*PED expires

    Listed listed patent expiration.

    Sep 21, 2028

    in 2 yr 4 mo

  17. Patent 7964580 expires

    Listed drug substance patent expiration.

    Mar 26, 2029

    in 2 yr 10 mo

  18. Patent 7964580 expires

    Listed drug substance patent expiration.

    Mar 26, 2029

    in 2 yr 10 mo

  19. Patent 8633309 expires

    Listed drug substance patent expiration.

    Mar 26, 2029

    in 2 yr 10 mo

  20. Patent 8633309 expires

    Listed drug substance patent expiration.

    Mar 26, 2029

    in 2 yr 10 mo

  21. Patent 8889159 expires

    Listed drug substance patent expiration.

    Mar 26, 2029

    in 2 yr 10 mo

  22. Patent 8889159 expires

    Listed drug substance patent expiration.

    Mar 26, 2029

    in 2 yr 10 mo

  23. Patent 7964580*PED expires

    Listed listed patent expiration.

    Sep 26, 2029

    in 3 yr 4 mo

  24. Patent 8633309*PED expires

    Listed listed patent expiration.

    Sep 26, 2029

    in 3 yr 4 mo

  25. Patent 8889159*PED expires

    Listed listed patent expiration.

    Sep 26, 2029

    in 3 yr 4 mo

  26. Patent 9284342 expires

    Listed drug substance patent expiration.

    Sep 13, 2030

    in 4 yr 4 mo

  27. Patent 9284342 expires

    Listed drug substance patent expiration.

    Sep 13, 2030

    in 4 yr 4 mo

  28. Patent 8618076 expires

    Listed drug substance patent expiration.

    Dec 11, 2030

    in 4 yr 7 mo

  29. Patent 8618076 expires

    Listed drug substance patent expiration.

    Dec 11, 2030

    in 4 yr 7 mo

  30. Patent 9284342*PED expires

    Listed listed patent expiration.

    Mar 13, 2031

    in 4 yr 10 mo

  31. Patent 8618076*PED expires

    Listed listed patent expiration.

    Jun 11, 2031

    in 5 yr 1 mo

  32. Patent 8575135 expires

    Listed drug substance patent expiration.

    Nov 16, 2032

    in 6 yr 6 mo

  33. Patent 8575135 expires

    Listed drug substance patent expiration.

    Nov 16, 2032

    in 6 yr 6 mo

  34. Patent 8921341 expires

    Listed drug substance patent expiration.

    Nov 16, 2032

    in 6 yr 6 mo

  35. Patent 8921341 expires

    Listed drug substance patent expiration.

    Nov 16, 2032

    in 6 yr 6 mo

  36. Patent 8940718 expires

    Listed drug substance patent expiration.

    Nov 16, 2032

    in 6 yr 6 mo

  37. Patent 8940718 expires

    Listed drug substance patent expiration.

    Nov 16, 2032

    in 6 yr 6 mo

  38. Patent 9868745 expires

    Listed drug substance patent expiration.

    Nov 16, 2032

    in 6 yr 6 mo

  39. Patent 8575135*PED expires

    Listed listed patent expiration.

    May 16, 2033

    in 7 yr

  40. Patent 8921341*PED expires

    Listed listed patent expiration.

    May 16, 2033

    in 7 yr

  41. Patent 8940718*PED expires

    Listed listed patent expiration.

    May 16, 2033

    in 7 yr

  42. Patent 11116783 expires

    Listed drug product patent expiration.

    Jan 30, 2034

    in 7 yr 9 mo

  43. Patent 11116783 expires

    Listed drug product patent expiration.

    Jan 30, 2034

    in 7 yr 9 mo

  44. Patent 9296782 expires

    Listed drug substance patent expiration.

    Jul 17, 2034

    in 8 yr 2 mo

  45. Patent 11116783*PED expires

    Listed listed patent expiration.

    Jul 30, 2034

    in 8 yr 3 mo

  46. Patent 10912814 expires

    Listed drug product patent expiration.

    Jun 01, 2037

    in 11 yr 1 mo

  47. Patent 11338007 expires

    Listed drug product patent expiration.

    Jun 01, 2037

    in 11 yr 1 mo

  48. Patent 11338007 expires

    Listed drug product patent expiration.

    Jun 01, 2037

    in 11 yr 1 mo

  49. Patent 11338007*PED expires

    Listed listed patent expiration.

    Dec 01, 2037

    in 11 yr 7 mo

Pharmaceutical detail

Active ingredient

SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR

Strength

400MG;100MG;100MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 209195

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.

Listed patents (47)

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-2040
8334270Mar 21, 2028in 1 yr 9 mo
SubstanceProductU-2039
8580765Mar 21, 2028in 1 yr 9 mo
SubstanceProductU-2040
8580765Mar 21, 2028in 1 yr 9 mo
SubstanceProductU-2039
8735372Mar 21, 2028in 1 yr 9 mo
SubstanceProductU-2040
8735372Mar 21, 2028in 1 yr 9 mo
SubstanceProductU-2039
8957046Mar 21, 2028in 1 yr 9 mo
U-2040
8957046Mar 21, 2028in 1 yr 9 mo
U-2039
9085573Mar 21, 2028in 1 yr 9 mo
SubstanceProductU-2040
9085573Mar 21, 2028in 1 yr 9 mo
SubstanceProductU-2039
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-2039
7964580Mar 26, 2029in 2 yr 10 mo
SubstanceProductU-2040
8633309Mar 26, 2029in 2 yr 10 mo
SubstanceProductU-2039
8633309Mar 26, 2029in 2 yr 10 mo
SubstanceProductU-2040
8889159Mar 26, 2029in 2 yr 10 mo
SubstanceProductU-2040
8889159Mar 26, 2029in 2 yr 10 mo
SubstanceProductU-2039
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-2040
9284342Sep 13, 2030in 4 yr 4 mo
SubstanceProductU-2039
8618076Dec 11, 2030in 4 yr 7 mo
SubstanceProductU-2040
8618076Dec 11, 2030in 4 yr 7 mo
SubstanceProductU-2039
9284342*PEDMar 13, 2031in 4 yr 10 mo
8618076*PEDJun 11, 2031in 5 yr 1 mo
8575135Nov 16, 2032in 6 yr 6 mo
SubstanceProductU-2040
8575135Nov 16, 2032in 6 yr 6 mo
SubstanceProductU-2039
8921341Nov 16, 2032in 6 yr 6 mo
SubstanceProductU-2040
8921341Nov 16, 2032in 6 yr 6 mo
SubstanceProductU-2039
8940718Nov 16, 2032in 6 yr 6 mo
SubstanceProductU-2039
8940718Nov 16, 2032in 6 yr 6 mo
SubstanceProductU-2040
9868745Nov 16, 2032in 6 yr 6 mo
SubstanceProduct
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-2039
11116783Jan 30, 2034in 7 yr 9 mo
ProductU-2040
9296782Jul 17, 2034in 8 yr 2 mo
SubstanceProduct
11116783*PEDJul 30, 2034in 8 yr 3 mo
10912814Jun 01, 2037in 11 yr 1 mo
Product
11338007Jun 01, 2037in 11 yr 1 mo
ProductU-2039
11338007Jun 01, 2037in 11 yr 1 mo
ProductU-2040
11338007*PEDDec 01, 2037in 11 yr 7 mo
Agent CTA Background

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