Assyro AI

Orange Book product · Brand (NDA)

BRUKINSA

ZANUBRUTINIB

Brand (NDA)NDA 218785RX BEONE MEDICINES USA
View ZANUBRUTINIB familyOpen on FDA Orange Book

At a glance

Jun 10, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

69

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 10, 2025

    1 yr ago

  2. Exclusivity ends · I-817

    New indication exclusivity (3 years)

    Jan 19, 2026

    5 mo ago

  3. Today

  4. Exclusivity ends · ODE*

    FDA marketing exclusivity

    Nov 14, 2026

    in 5 mo

  5. Exclusivity ends · I-936

    New indication exclusivity (3 years)

    Mar 07, 2027

    in 9 mo

  6. Exclusivity ends · ODE*

    FDA marketing exclusivity

    Aug 31, 2028

    in 2 yr 3 mo

  7. Exclusivity ends · ODE*

    FDA marketing exclusivity

    Sep 14, 2028

    in 2 yr 3 mo

  8. Exclusivity ends · ODE*

    FDA marketing exclusivity

    Jan 19, 2030

    in 3 yr 8 mo

  9. Exclusivity ends · ODE*

    FDA marketing exclusivity

    Mar 07, 2031

    in 4 yr 9 mo

  10. Patent 10570139 expires

    Listed method-of-use patent (U-1745) expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  11. Patent 10570139 expires

    Listed method-of-use patent (U-3860) expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  12. Patent 10570139 expires

    Listed method-of-use patent (U-3486) expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  13. Patent 10570139 expires

    Listed method-of-use patent (U-3063) expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  14. Patent 10570139 expires

    Listed method-of-use patent (U-2666) expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  15. Patent 10570139 expires

    Listed method-of-use patent (U-2537) expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  16. Patent 10570139 expires

    Listed method-of-use patent (U-2145) expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  17. Patent 11142528 expires

    Listed drug product patent expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  18. Patent 11142528 expires

    Listed drug product patent expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  19. Patent 11142528 expires

    Listed drug product patent expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  20. Patent 11142528 expires

    Listed drug product patent expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  21. Patent 11142528 expires

    Listed drug product patent expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  22. Patent 11142528 expires

    Listed drug product patent expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  23. Patent 11142528 expires

    Listed drug product patent expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  24. Patent 9447106 expires

    Listed drug substance patent expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  25. Patent 9447106 expires

    Listed drug substance patent expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  26. Patent 9447106 expires

    Listed drug substance patent expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  27. Patent 9447106 expires

    Listed drug substance patent expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  28. Patent 9447106 expires

    Listed drug substance patent expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  29. Patent 9447106 expires

    Listed drug substance patent expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  30. Patent 9447106 expires

    Listed drug substance patent expiration.

    Apr 22, 2034

    in 7 yr 11 mo

  31. Patent 10927117 expires

    Listed drug substance patent expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  32. Patent 11591340 expires

    Listed method-of-use patent (U-3728) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  33. Patent 11591340 expires

    Listed method-of-use patent (U-3727) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  34. Patent 11591340 expires

    Listed method-of-use patent (U-3486) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  35. Patent 11591340 expires

    Listed method-of-use patent (U-3063) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  36. Patent 11591340 expires

    Listed method-of-use patent (U-2666) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  37. Patent 11591340 expires

    Listed method-of-use patent (U-2537) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  38. Patent 11591340 expires

    Listed method-of-use patent (U-2145) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  39. Patent 11591340 expires

    Listed method-of-use patent (U-1745) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  40. Patent 11591340 expires

    Listed method-of-use patent (U-3729) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  41. Patent 11851437 expires

    Listed drug substance patent expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  42. Patent 11884674 expires

    Listed method-of-use patent (U-1745) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  43. Patent 11884674 expires

    Listed method-of-use patent (U-3860) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  44. Patent 11884674 expires

    Listed method-of-use patent (U-3486) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  45. Patent 11884674 expires

    Listed method-of-use patent (U-3063) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  46. Patent 11884674 expires

    Listed method-of-use patent (U-2666) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  47. Patent 11884674 expires

    Listed method-of-use patent (U-2537) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  48. Patent 11884674 expires

    Listed method-of-use patent (U-2145) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  49. Patent 11970500 expires

    Listed method-of-use patent (U-1745) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  50. Patent 11970500 expires

    Listed method-of-use patent (U-3860) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  51. Patent 11970500 expires

    Listed method-of-use patent (U-3486) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  52. Patent 11970500 expires

    Listed method-of-use patent (U-3063) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  53. Patent 11970500 expires

    Listed method-of-use patent (U-2666) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  54. Patent 11970500 expires

    Listed method-of-use patent (U-2537) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  55. Patent 11970500 expires

    Listed method-of-use patent (U-2145) expiration.

    Aug 15, 2037

    in 11 yr 4 mo

  56. Patent 11701357 expires

    Listed method-of-use patent (U-3860) expiration.

    Jun 24, 2039

    in 13 yr 2 mo

  57. Patent 12233069 expires

    Listed drug product patent expiration.

    Jun 10, 2040

    in 14 yr 2 mo

  58. Patent 11786531 expires

    Listed method-of-use patent (U-3715) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  59. Patent 11786531 expires

    Listed method-of-use patent (U-3875) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  60. Patent 11786531 expires

    Listed method-of-use patent (U-3720) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  61. Patent 11786531 expires

    Listed method-of-use patent (U-3719) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  62. Patent 11786531 expires

    Listed method-of-use patent (U-3718) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  63. Patent 11786531 expires

    Listed method-of-use patent (U-3717) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  64. Patent 11786531 expires

    Listed method-of-use patent (U-3716) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  65. Patent 11896596 expires

    Listed method-of-use patent (U-3715) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  66. Patent 11896596 expires

    Listed method-of-use patent (U-3875) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  67. Patent 11896596 expires

    Listed method-of-use patent (U-3720) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  68. Patent 11896596 expires

    Listed method-of-use patent (U-3719) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  69. Patent 11896596 expires

    Listed method-of-use patent (U-3718) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  70. Patent 11896596 expires

    Listed method-of-use patent (U-3717) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  71. Patent 11896596 expires

    Listed method-of-use patent (U-3716) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  72. Patent 11911386 expires

    Listed method-of-use patent (U-3715) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  73. Patent 11911386 expires

    Listed method-of-use patent (U-3716) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  74. Patent 11911386 expires

    Listed method-of-use patent (U-3717) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  75. Patent 11911386 expires

    Listed method-of-use patent (U-3718) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  76. Patent 11911386 expires

    Listed method-of-use patent (U-3719) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  77. Patent 11911386 expires

    Listed method-of-use patent (U-3720) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

  78. Patent 11911386 expires

    Listed method-of-use patent (U-3875) expiration.

    Jan 19, 2043

    in 16 yr 10 mo

Pharmaceutical detail

Active ingredient

ZANUBRUTINIB

Strength

160MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 218785

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 (7)

  • I-817New indication exclusivity (3 years)

    Jan 19, 2026

    5 mo ago

  • ODE*FDA marketing exclusivity

    Nov 14, 2026

    in 5 mo

  • I-936New indication exclusivity (3 years)

    Mar 07, 2027

    in 9 mo

  • ODE*FDA marketing exclusivity

    Aug 31, 2028

    in 2 yr 3 mo

  • ODE*FDA marketing exclusivity

    Sep 14, 2028

    in 2 yr 3 mo

  • ODE*FDA marketing exclusivity

    Jan 19, 2030

    in 3 yr 8 mo

  • ODE*FDA marketing exclusivity

    Mar 07, 2031

    in 4 yr 9 mo

Listed patents (69)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10570139Apr 22, 2034in 7 yr 11 mo
U-1745
10570139Apr 22, 2034in 7 yr 11 mo
U-3860
10570139Apr 22, 2034in 7 yr 11 mo
U-3486
10570139Apr 22, 2034in 7 yr 11 mo
U-3063
10570139Apr 22, 2034in 7 yr 11 mo
U-2666
10570139Apr 22, 2034in 7 yr 11 mo
U-2537
10570139Apr 22, 2034in 7 yr 11 mo
U-2145
11142528Apr 22, 2034in 7 yr 11 mo
ProductU-1745
11142528Apr 22, 2034in 7 yr 11 mo
ProductU-3860
11142528Apr 22, 2034in 7 yr 11 mo
ProductU-3486
11142528Apr 22, 2034in 7 yr 11 mo
ProductU-3063
11142528Apr 22, 2034in 7 yr 11 mo
ProductU-2666
11142528Apr 22, 2034in 7 yr 11 mo
ProductU-2537
11142528Apr 22, 2034in 7 yr 11 mo
ProductU-2145
9447106Apr 22, 2034in 7 yr 11 mo
SubstanceProductU-1745
9447106Apr 22, 2034in 7 yr 11 mo
SubstanceProductU-2145
9447106Apr 22, 2034in 7 yr 11 mo
SubstanceProductU-2537
9447106Apr 22, 2034in 7 yr 11 mo
SubstanceProductU-2666
9447106Apr 22, 2034in 7 yr 11 mo
SubstanceProductU-3063
9447106Apr 22, 2034in 7 yr 11 mo
SubstanceProductU-3486
9447106Apr 22, 2034in 7 yr 11 mo
SubstanceProductU-3860
10927117Aug 15, 2037in 11 yr 4 mo
SubstanceProduct
11591340Aug 15, 2037in 11 yr 4 mo
U-3728
11591340Aug 15, 2037in 11 yr 4 mo
U-3727
11591340Aug 15, 2037in 11 yr 4 mo
U-3486
11591340Aug 15, 2037in 11 yr 4 mo
U-3063
11591340Aug 15, 2037in 11 yr 4 mo
U-2666
11591340Aug 15, 2037in 11 yr 4 mo
U-2537
11591340Aug 15, 2037in 11 yr 4 mo
U-2145
11591340Aug 15, 2037in 11 yr 4 mo
U-1745
11591340Aug 15, 2037in 11 yr 4 mo
U-3729
11851437Aug 15, 2037in 11 yr 4 mo
SubstanceProduct
11884674Aug 15, 2037in 11 yr 4 mo
U-1745
11884674Aug 15, 2037in 11 yr 4 mo
U-3860
11884674Aug 15, 2037in 11 yr 4 mo
U-3486
11884674Aug 15, 2037in 11 yr 4 mo
U-3063
11884674Aug 15, 2037in 11 yr 4 mo
U-2666
11884674Aug 15, 2037in 11 yr 4 mo
U-2537
11884674Aug 15, 2037in 11 yr 4 mo
U-2145
11970500Aug 15, 2037in 11 yr 4 mo
U-1745
11970500Aug 15, 2037in 11 yr 4 mo
U-3860
11970500Aug 15, 2037in 11 yr 4 mo
U-3486
11970500Aug 15, 2037in 11 yr 4 mo
U-3063
11970500Aug 15, 2037in 11 yr 4 mo
U-2666
11970500Aug 15, 2037in 11 yr 4 mo
U-2537
11970500Aug 15, 2037in 11 yr 4 mo
U-2145
11701357Jun 24, 2039in 13 yr 2 mo
U-3860
12233069Jun 10, 2040in 14 yr 2 mo
Product
11786531Jan 19, 2043in 16 yr 10 mo
U-3715
11786531Jan 19, 2043in 16 yr 10 mo
U-3875
11786531Jan 19, 2043in 16 yr 10 mo
U-3720
11786531Jan 19, 2043in 16 yr 10 mo
U-3719
11786531Jan 19, 2043in 16 yr 10 mo
U-3718
11786531Jan 19, 2043in 16 yr 10 mo
U-3717
11786531Jan 19, 2043in 16 yr 10 mo
U-3716
11896596Jan 19, 2043in 16 yr 10 mo
U-3715
11896596Jan 19, 2043in 16 yr 10 mo
U-3875
11896596Jan 19, 2043in 16 yr 10 mo
U-3720
11896596Jan 19, 2043in 16 yr 10 mo
U-3719
11896596Jan 19, 2043in 16 yr 10 mo
U-3718
11896596Jan 19, 2043in 16 yr 10 mo
U-3717
11896596Jan 19, 2043in 16 yr 10 mo
U-3716
11911386Jan 19, 2043in 16 yr 10 mo
U-3715
11911386Jan 19, 2043in 16 yr 10 mo
U-3716
11911386Jan 19, 2043in 16 yr 10 mo
U-3717
11911386Jan 19, 2043in 16 yr 10 mo
U-3718
11911386Jan 19, 2043in 16 yr 10 mo
U-3719
11911386Jan 19, 2043in 16 yr 10 mo
U-3720
11911386Jan 19, 2043in 16 yr 10 mo
U-3875
Agent CTA Background

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