Skip to content
Assyro AI
Purple Book reference family · 351(a) biologic

denosumab (Prolia)

denosumab is an FDA-licensed reference biologic from Amgen Inc., with 11 approved follow-on biologics.

351(a) biologicBLA 125320 Amgen Inc.
Biosimilars
0
Interchangeables
11
Listed patents
57
Reference approved
2010

Reference product

Originator biologic
351(a)BLA 125320

Prolia denosumab

Amgen Inc.

View full reference-product record
Approved
Marketing
Rx
Center
CDER
Patents
57 listed

Exclusivity & patent cliffs

Protection horizon

  1. Reference approval

    Approval date of the reference denosumab product.

    16 yr 6 mo ago

  2. Patent 8,058,418 expires

    Published Purple Book patent expiration.

    2 yr 10 mo ago

  3. Patent 7,364,736 expires

    Published Purple Book patent expiration.

    1 yr 7 mo ago

  4. Patent 7,427,659 expires

    Published Purple Book patent expiration.

    1 yr 6 mo ago

  5. Patent 8,247,210 expires

    Published Purple Book patent expiration.

    in 3 mo

  6. Patent 8,460,896 expires

    Published Purple Book patent expiration.

    in 3 mo

  7. Patent 8,680,248 expires

    Published Purple Book patent expiration.

    in 3 mo

  8. Patent 8,217,153 expires

    Published Purple Book patent expiration.

    in 4 mo

  9. Patent 7,928,205 expires

    Published Purple Book patent expiration.

    in 5 mo

  10. Patent 7,888,101 expires

    Published Purple Book patent expiration.

    in 7 mo

  11. Patent 7,662,930 expires

    Published Purple Book patent expiration.

    in 8 mo

  12. Patent 9,359,435 expires

    Published Purple Book patent expiration.

    in 9 mo

  13. Patent 8,053,236 expires

    Published Purple Book patent expiration.

    in 3 yr 5 mo

  14. Patent 9,228,168 expires

    Published Purple Book patent expiration.

    in 3 yr 5 mo

  15. Patent 9,320,816 expires

    Published Purple Book patent expiration.

    in 4 yr 3 mo

  16. Patent 9,012,178 expires

    Published Purple Book patent expiration.

    in 5 yr

  17. Patent 9,133,493 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  18. Patent 9,388,447 expires

    Published Purple Book patent expiration.

    in 5 yr 8 mo

  19. Patent 11,292,829 expires

    Published Purple Book patent expiration.

    in 5 yr 11 mo

  20. Patent 11,634,476 expires

    Published Purple Book patent expiration.

    in 5 yr 11 mo

  21. Patent 11,685,772 expires

    Published Purple Book patent expiration.

    in 5 yr 11 mo

  22. Patent 9,371,554 expires

    Published Purple Book patent expiration.

    in 6 yr 4 mo

  23. Patent 11,293,930 expires

    Published Purple Book patent expiration.

    in 6 yr 8 mo

  24. Patent 11,486,883 expires

    Published Purple Book patent expiration.

    in 6 yr 8 mo

  25. Patent 9,328,134 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  26. Patent 11,319,568 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  27. Patent 11,459,595 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  28. Patent 11,952,605 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  29. Patent 12,084,686 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  30. Patent 11,492,372 expires

    Published Purple Book patent expiration.

    in 7 yr 7 mo

  31. Patent 10,421,987 expires

    Published Purple Book patent expiration.

    in 7 yr 10 mo

  32. Patent 10,894,972 expires

    Published Purple Book patent expiration.

    in 7 yr 10 mo

  33. Patent 11,434,514 expires

    Published Purple Book patent expiration.

    in 7 yr 10 mo

  34. Patent 11,946,085 expires

    Published Purple Book patent expiration.

    in 7 yr 10 mo

  35. Patent 9,481,901 expires

    Published Purple Book patent expiration.

    in 7 yr 10 mo

  36. Patent 9,803,166 expires

    Published Purple Book patent expiration.

    in 8 yr 2 mo

  37. Patent 11,299,760 expires

    Published Purple Book patent expiration.

    in 8 yr 3 mo

  38. Patent 10,513,723 expires

    Published Purple Book patent expiration.

    in 8 yr 4 mo

  39. Patent 11,254,963 expires

    Published Purple Book patent expiration.

    in 8 yr 4 mo

  40. Patent 10,106,829 expires

    Published Purple Book patent expiration.

    in 8 yr 5 mo

  41. Patent 10,227,627 expires

    Published Purple Book patent expiration.

    in 8 yr 5 mo

  42. Patent 10,655,156 expires

    Published Purple Book patent expiration.

    in 8 yr 5 mo

  43. Patent 10,907,186 expires

    Published Purple Book patent expiration.

    in 8 yr 5 mo

  44. Patent 11,130,980 expires

    Published Purple Book patent expiration.

    in 8 yr 8 mo

  45. Patent 11,077,404 expires

    Published Purple Book patent expiration.

    in 8 yr 10 mo

  46. Patent 11,384,378 expires

    Published Purple Book patent expiration.

    in 8 yr 10 mo

  47. Patent 11,427,848 expires

    Published Purple Book patent expiration.

    in 8 yr 10 mo

  48. Patent 10,583,397 expires

    Published Purple Book patent expiration.

    in 9 yr

  49. Patent 11,786,866 expires

    Published Purple Book patent expiration.

    in 9 yr 3 mo

  50. Patent 11,192,919 expires

    Published Purple Book patent expiration.

    in 9 yr 4 mo

  51. Patent 10,167,492 expires

    Published Purple Book patent expiration.

    in 9 yr 4 mo

  52. Patent 10,822,630 expires

    Published Purple Book patent expiration.

    in 9 yr 4 mo

  53. Patent 11,275,090 expires

    Published Purple Book patent expiration.

    in 11 yr

  54. Patent 11,098,079 expires

    Published Purple Book patent expiration.

    in 11 yr

  55. Patent 9,881,367 expires

    Published Purple Book patent expiration.

    in 11 yr 1 mo

  56. Patent 12,025,618 expires

    Published Purple Book patent expiration.

    in 13 yr 2 mo

  57. Patent 11,744,950 expires

    Published Purple Book patent expiration.

    in 13 yr 5 mo

  58. Patent 12,059,555 expires

    Published Purple Book patent expiration.

    in 14 yr 2 mo

Biosimilars & interchangeables for denosumab

Follow-on biologics
Biosimilars and interchangeable biosimilars referencing denosumab.
ProductProper nameApplicantTypeBLAApproved
Jubbontidenosumab-bbdzSandoz Inc.Interchangeable761362
Ospomyvdenosumab-dssbSamsung Bioepis Co., Ltd.Interchangeable761392
Osenveltdenosumab-bmwoCELLTRION, Inc.Interchangeable761404
Bomyntradenosumab-bnhtFresenius Kabi USA, LLCInterchangeable761398
Bildyosdenosumab-nxxpShanghai Henlius Biotech, Inc.Interchangeable761444
Aukelsodenosumab-kyqqBiocon Biologics Inc.Interchangeable761436
Enobydenosumab-qbdeHikma Pharmaceuticals USA Inc.Interchangeable761439
Jubereqdenosumab-desuAccord BioPharma Inc.Interchangeable761424
Boncresadenosumab-mobzAmneal Pharmaceuticals LLCInterchangeable761456
Oziltusdenosumab-mobzAmneal Pharmaceuticals LLCInterchangeable761457
Ponlimsidenosumab-adetTeva Pharmaceuticals, Inc.Interchangeable761385

Published patents

Purple Book patent list
Published Purple Book patents for denosumab.
PatentExpiresIn
8,058,4182 yr 10 mo ago
7,364,7361 yr 7 mo ago
7,427,6591 yr 6 mo ago
8,247,210in 3 mo
8,460,896in 3 mo
8,680,248in 3 mo
8,217,153in 4 mo
7,928,205in 5 mo
7,888,101in 7 mo
7,662,930in 8 mo
9,359,435in 9 mo
8,053,236in 3 yr 5 mo
9,228,168in 3 yr 5 mo
9,320,816in 4 yr 3 mo
9,012,178in 5 yr
9,133,493in 5 yr 8 mo
9,388,447in 5 yr 8 mo
11,292,829in 5 yr 11 mo
11,634,476in 5 yr 11 mo
11,685,772in 5 yr 11 mo
9,371,554in 6 yr 4 mo
11,293,930in 6 yr 8 mo
11,486,883in 6 yr 8 mo
9,328,134in 7 yr 7 mo
11,319,568in 7 yr 7 mo
11,459,595in 7 yr 7 mo
11,952,605in 7 yr 7 mo
12,084,686in 7 yr 7 mo
11,492,372in 7 yr 7 mo
10,421,987in 7 yr 10 mo
10,894,972in 7 yr 10 mo
11,434,514in 7 yr 10 mo
11,946,085in 7 yr 10 mo
9,481,901in 7 yr 10 mo
9,803,166in 8 yr 2 mo
11,299,760in 8 yr 3 mo
10,513,723in 8 yr 4 mo
11,254,963in 8 yr 4 mo
10,106,829in 8 yr 5 mo
10,227,627in 8 yr 5 mo
10,655,156in 8 yr 5 mo
10,907,186in 8 yr 5 mo
11,130,980in 8 yr 8 mo
11,077,404in 8 yr 10 mo
11,384,378in 8 yr 10 mo
11,427,848in 8 yr 10 mo
10,583,397in 9 yr
11,786,866in 9 yr 3 mo
11,192,919in 9 yr 4 mo
10,167,492in 9 yr 4 mo
10,822,630in 9 yr 4 mo
11,275,090in 11 yr
11,098,079in 11 yr
9,881,367in 11 yr 1 mo
12,025,618in 13 yr 2 mo
11,744,950in 13 yr 5 mo
12,059,555in 14 yr 2 mo

denosumab: frequently asked questions

Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.

Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for denosumab.

Related FDA reference tools

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo