Assyro AI

Orange Book product · Brand (NDA)

RINVOQ

UPADACITINIB

Brand (NDA)NDA 211675RX ABBVIE
View UPADACITINIB familyOpen on FDA Orange Book

At a glance

Aug 16, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

53

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 16, 2019

    6 yr 11 mo ago

  2. Exclusivity ends · I-919

    New indication exclusivity (3 years)

    May 18, 2026

    1 mo ago

  3. Today

  4. Exclusivity ends · I-946

    New indication exclusivity (3 years)

    Apr 26, 2027

    in 10 mo

  5. Exclusivity ends · NPP

    New patient population exclusivity (3 years)

    Apr 26, 2027

    in 10 mo

  6. Exclusivity ends · I-966

    New indication exclusivity (3 years)

    Apr 28, 2028

    in 1 yr 11 mo

  7. Patent 8962629 expires

    Listed drug substance patent expiration.

    Jan 15, 2031

    in 4 yr 8 mo

  8. Patent 8962629 expires

    Listed drug substance patent expiration.

    Jan 15, 2031

    in 4 yr 8 mo

  9. Patent 8962629 expires

    Listed drug substance patent expiration.

    Jan 15, 2031

    in 4 yr 8 mo

  10. Patent 8962629 expires

    Listed drug substance patent expiration.

    Jan 15, 2031

    in 4 yr 8 mo

  11. Patent 8962629 expires

    Listed drug substance patent expiration.

    Jan 15, 2031

    in 4 yr 8 mo

  12. Patent 8962629 expires

    Listed drug substance patent expiration.

    Jan 15, 2031

    in 4 yr 8 mo

  13. Patent 8962629 expires

    Listed drug substance patent expiration.

    Jan 15, 2031

    in 4 yr 8 mo

  14. Exclusivity ends · ODE-481

    Orphan-drug exclusivity (7 years)

    Apr 26, 2031

    in 4 yr 11 mo

  15. Exclusivity ends · ODE-538

    Orphan-drug exclusivity (7 years)

    Apr 28, 2032

    in 5 yr 11 mo

  16. Patent RE47221 expires

    Listed drug substance patent expiration.

    Aug 16, 2033

    in 7 yr 3 mo

  17. Patent 10519164 expires

    Listed drug product patent expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  18. Patent 10597400 expires

    Listed method-of-use patent (U-3255) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  19. Patent 10981923 expires

    Listed drug substance patent expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  20. Patent 10981924 expires

    Listed drug product patent expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  21. Patent 10995095 expires

    Listed method-of-use patent (U-3298) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  22. Patent 11186584 expires

    Listed drug substance patent expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  23. Patent 11198697 expires

    Listed drug product patent expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  24. Patent 11365198 expires

    Listed method-of-use patent (U-3946) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  25. Patent 11365198 expires

    Listed method-of-use patent (U-3275) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  26. Patent 11512092 expires

    Listed method-of-use patent (U-3946) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  27. Patent 11512092 expires

    Listed method-of-use patent (U-3275) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  28. Patent 11512092 expires

    Listed method-of-use patent (U-3487) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  29. Patent 11512092 expires

    Listed method-of-use patent (U-3371) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  30. Patent 11524964 expires

    Listed method-of-use patent (U-3371) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  31. Patent 11535624 expires

    Listed method-of-use patent (U-3255) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  32. Patent 11535625 expires

    Listed method-of-use patent (U-3298) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  33. Patent 11661425 expires

    Listed drug substance patent expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  34. Patent 11680069 expires

    Listed drug substance patent expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  35. Patent 11718627 expires

    Listed drug substance patent expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  36. Patent 11767326 expires

    Listed method-of-use patent (U-3298) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  37. Patent 11773105 expires

    Listed drug substance patent expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  38. Patent 11773106 expires

    Listed method-of-use patent (U-3946) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  39. Patent 11773106 expires

    Listed method-of-use patent (U-3275) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  40. Patent 11773106 expires

    Listed method-of-use patent (U-3487) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  41. Patent 11773106 expires

    Listed method-of-use patent (U-3371) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  42. Patent 11780847 expires

    Listed drug product patent expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  43. Patent 11780848 expires

    Listed method-of-use patent (U-3371) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  44. Patent 11787815 expires

    Listed drug product patent expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  45. Patent 11795175 expires

    Listed method-of-use patent (U-3255) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  46. Patent 11976077 expires

    Listed method-of-use patent (U-3298) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  47. Patent 11993605 expires

    Listed method-of-use patent (U-3275) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  48. Patent 11993605 expires

    Listed method-of-use patent (U-3946) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  49. Patent 11993606 expires

    Listed method-of-use patent (U-3487) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  50. Patent 12077545 expires

    Listed drug product patent expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  51. Patent 12103933 expires

    Listed drug product patent expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  52. Patent 12110297 expires

    Listed drug product patent expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  53. Patent 12110298 expires

    Listed drug substance patent expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  54. Patent 12365689 expires

    Listed method-of-use patent (U-3945) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  55. Patent 12570664 expires

    Listed method-of-use patent (U-4454) expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  56. Patent 9951080 expires

    Listed drug substance patent expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  57. Patent 9963459 expires

    Listed drug product patent expiration.

    Oct 17, 2036

    in 10 yr 6 mo

  58. Patent 11564922 expires

    Listed method-of-use patent (U-4303) expiration.

    Mar 09, 2038

    in 11 yr 11 mo

  59. Patent 11564922 expires

    Listed method-of-use patent (U-3624) expiration.

    Mar 09, 2038

    in 11 yr 11 mo

  60. Patent 11607411 expires

    Listed method-of-use patent (U-4302) expiration.

    Mar 09, 2038

    in 11 yr 11 mo

  61. Patent 11607411 expires

    Listed method-of-use patent (U-3341) expiration.

    Mar 09, 2038

    in 11 yr 11 mo

Pharmaceutical detail

Active ingredient

UPADACITINIB

Strength

15MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 211675

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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 (6)

  • I-919New indication exclusivity (3 years)

    May 18, 2026

    1 mo ago

  • I-946New indication exclusivity (3 years)

    Apr 26, 2027

    in 10 mo

  • NPPNew patient population exclusivity (3 years)

    Apr 26, 2027

    in 10 mo

  • I-966New indication exclusivity (3 years)

    Apr 28, 2028

    in 1 yr 11 mo

  • ODE-481Orphan-drug exclusivity (7 years)

    Apr 26, 2031

    in 4 yr 11 mo

  • ODE-538Orphan-drug exclusivity (7 years)

    Apr 28, 2032

    in 5 yr 11 mo

Listed patents (53)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8962629Jan 15, 2031in 4 yr 8 mo
SubstanceU-3371
8962629Jan 15, 2031in 4 yr 8 mo
SubstanceU-3624
8962629Jan 15, 2031in 4 yr 8 mo
SubstanceU-3946
8962629Jan 15, 2031in 4 yr 8 mo
SubstanceU-3945
8962629Jan 15, 2031in 4 yr 8 mo
SubstanceU-3275
8962629Jan 15, 2031in 4 yr 8 mo
SubstanceU-3255
8962629Jan 15, 2031in 4 yr 8 mo
SubstanceU-3341
RE47221Aug 16, 2033in 7 yr 3 mo
Substance
10519164Oct 17, 2036in 10 yr 6 mo
Product
10597400Oct 17, 2036in 10 yr 6 mo
U-3255
10981923Oct 17, 2036in 10 yr 6 mo
Substance
10981924Oct 17, 2036in 10 yr 6 mo
Product
10995095Oct 17, 2036in 10 yr 6 mo
U-3298
11186584Oct 17, 2036in 10 yr 6 mo
Substance
11198697Oct 17, 2036in 10 yr 6 mo
Product
11365198Oct 17, 2036in 10 yr 6 mo
U-3946
11365198Oct 17, 2036in 10 yr 6 mo
U-3275
11512092Oct 17, 2036in 10 yr 6 mo
U-3946
11512092Oct 17, 2036in 10 yr 6 mo
U-3275
11512092Oct 17, 2036in 10 yr 6 mo
U-3487
11512092Oct 17, 2036in 10 yr 6 mo
U-3371
11524964Oct 17, 2036in 10 yr 6 mo
U-3371
11535624Oct 17, 2036in 10 yr 6 mo
U-3255
11535625Oct 17, 2036in 10 yr 6 mo
U-3298
11661425Oct 17, 2036in 10 yr 6 mo
SubstanceProduct
11680069Oct 17, 2036in 10 yr 6 mo
SubstanceProduct
11718627Oct 17, 2036in 10 yr 6 mo
SubstanceProduct
11767326Oct 17, 2036in 10 yr 6 mo
U-3298
11773105Oct 17, 2036in 10 yr 6 mo
SubstanceProduct
11773106Oct 17, 2036in 10 yr 6 mo
U-3946
11773106Oct 17, 2036in 10 yr 6 mo
U-3275
11773106Oct 17, 2036in 10 yr 6 mo
U-3487
11773106Oct 17, 2036in 10 yr 6 mo
U-3371
11780847Oct 17, 2036in 10 yr 6 mo
Product
11780848Oct 17, 2036in 10 yr 6 mo
U-3371
11787815Oct 17, 2036in 10 yr 6 mo
Product
11795175Oct 17, 2036in 10 yr 6 mo
U-3255
11976077Oct 17, 2036in 10 yr 6 mo
U-3298
11993605Oct 17, 2036in 10 yr 6 mo
U-3275
11993605Oct 17, 2036in 10 yr 6 mo
U-3946
11993606Oct 17, 2036in 10 yr 6 mo
U-3487
12077545Oct 17, 2036in 10 yr 6 mo
Product
12103933Oct 17, 2036in 10 yr 6 mo
Product
12110297Oct 17, 2036in 10 yr 6 mo
Product
12110298Oct 17, 2036in 10 yr 6 mo
SubstanceProduct
12365689Oct 17, 2036in 10 yr 6 mo
U-3945
12570664Oct 17, 2036in 10 yr 6 mo
U-4454
9951080Oct 17, 2036in 10 yr 6 mo
SubstanceProduct
9963459Oct 17, 2036in 10 yr 6 mo
Product
11564922Mar 09, 2038in 11 yr 11 mo
U-4303
11564922Mar 09, 2038in 11 yr 11 mo
U-3624
11607411Mar 09, 2038in 11 yr 11 mo
U-4302
11607411Mar 09, 2038in 11 yr 11 mo
U-3341
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