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FDA Purple Book · Reference family

denosumab (Prolia)

denosumab is an FDA-licensed reference biologic from Amgen Inc., with 11 approved follow-on biologics. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

11

Interchangeables

57

Listed patents

2010

Reference approved

Reference product

351(a)BLA 125320

Prolia denosumab

Amgen Inc.

Approved
Jun 01, 2010
Marketing
Rx
Center
CDER
Patents
57 listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for denosumab, in chronological order.

  1. Reference approval

    Approval date of the reference denosumab product.

    16 yr 3 mo ago

  2. Patent 8,058,418 expires

    Published Purple Book patent expiration.

    2 yr 6 mo ago

  3. Patent 7,364,736 expires

    Published Purple Book patent expiration.

    1 yr 4 mo ago

  4. Patent 7,427,659 expires

    Published Purple Book patent expiration.

    1 yr 3 mo ago

  5. Patent 8,247,210 expires

    Published Purple Book patent expiration.

    in 6 mo

  6. Patent 8,460,896 expires

    Published Purple Book patent expiration.

    in 6 mo

  7. Patent 8,680,248 expires

    Published Purple Book patent expiration.

    in 6 mo

  8. Patent 8,217,153 expires

    Published Purple Book patent expiration.

    in 7 mo

  9. Patent 7,928,205 expires

    Published Purple Book patent expiration.

    in 9 mo

  10. Patent 7,888,101 expires

    Published Purple Book patent expiration.

    in 10 mo

  11. Patent 7,662,930 expires

    Published Purple Book patent expiration.

    in 11 mo

  12. Patent 9,359,435 expires

    Published Purple Book patent expiration.

    in 1 yr

  13. Patent 8,053,236 expires

    Published Purple Book patent expiration.

    in 3 yr 8 mo

  14. Patent 9,228,168 expires

    Published Purple Book patent expiration.

    in 3 yr 8 mo

  15. Patent 9,320,816 expires

    Published Purple Book patent expiration.

    in 4 yr 6 mo

  16. Patent 9,012,178 expires

    Published Purple Book patent expiration.

    in 5 yr 3 mo

  17. Patent 9,133,493 expires

    Published Purple Book patent expiration.

    in 6 yr

  18. Patent 9,388,447 expires

    Published Purple Book patent expiration.

    in 6 yr

  19. Patent 11,292,829 expires

    Published Purple Book patent expiration.

    in 6 yr 2 mo

  20. Patent 11,634,476 expires

    Published Purple Book patent expiration.

    in 6 yr 2 mo

  21. Patent 11,685,772 expires

    Published Purple Book patent expiration.

    in 6 yr 2 mo

  22. Patent 9,371,554 expires

    Published Purple Book patent expiration.

    in 6 yr 8 mo

  23. Patent 11,293,930 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  24. Patent 11,486,883 expires

    Published Purple Book patent expiration.

    in 6 yr 11 mo

  25. Patent 9,328,134 expires

    Published Purple Book patent expiration.

    in 7 yr 10 mo

  26. Patent 11,319,568 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  27. Patent 11,459,595 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  28. Patent 11,952,605 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  29. Patent 12,084,686 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  30. Patent 11,492,372 expires

    Published Purple Book patent expiration.

    in 7 yr 11 mo

  31. Patent 10,421,987 expires

    Published Purple Book patent expiration.

    in 8 yr 1 mo

  32. Patent 10,894,972 expires

    Published Purple Book patent expiration.

    in 8 yr 1 mo

  33. Patent 11,434,514 expires

    Published Purple Book patent expiration.

    in 8 yr 1 mo

  34. Patent 11,946,085 expires

    Published Purple Book patent expiration.

    in 8 yr 1 mo

  35. Patent 9,481,901 expires

    Published Purple Book patent expiration.

    in 8 yr 1 mo

  36. Patent 9,803,166 expires

    Published Purple Book patent expiration.

    in 8 yr 5 mo

  37. Patent 11,299,760 expires

    Published Purple Book patent expiration.

    in 8 yr 6 mo

  38. Patent 10,513,723 expires

    Published Purple Book patent expiration.

    in 8 yr 8 mo

  39. Patent 11,254,963 expires

    Published Purple Book patent expiration.

    in 8 yr 8 mo

  40. Patent 10,106,829 expires

    Published Purple Book patent expiration.

    in 8 yr 8 mo

  41. Patent 10,227,627 expires

    Published Purple Book patent expiration.

    in 8 yr 8 mo

  42. Patent 10,655,156 expires

    Published Purple Book patent expiration.

    in 8 yr 8 mo

  43. Patent 10,907,186 expires

    Published Purple Book patent expiration.

    in 8 yr 8 mo

  44. Patent 11,130,980 expires

    Published Purple Book patent expiration.

    in 9 yr

  45. Patent 11,077,404 expires

    Published Purple Book patent expiration.

    in 9 yr 1 mo

  46. Patent 11,384,378 expires

    Published Purple Book patent expiration.

    in 9 yr 2 mo

  47. Patent 11,427,848 expires

    Published Purple Book patent expiration.

    in 9 yr 2 mo

  48. Patent 10,583,397 expires

    Published Purple Book patent expiration.

    in 9 yr 3 mo

  49. Patent 11,786,866 expires

    Published Purple Book patent expiration.

    in 9 yr 6 mo

  50. Patent 11,192,919 expires

    Published Purple Book patent expiration.

    in 9 yr 7 mo

  51. Patent 10,167,492 expires

    Published Purple Book patent expiration.

    in 9 yr 8 mo

  52. Patent 10,822,630 expires

    Published Purple Book patent expiration.

    in 9 yr 8 mo

  53. Patent 11,275,090 expires

    Published Purple Book patent expiration.

    in 11 yr 3 mo

  54. Patent 11,098,079 expires

    Published Purple Book patent expiration.

    in 11 yr 4 mo

  55. Patent 9,881,367 expires

    Published Purple Book patent expiration.

    in 11 yr 4 mo

  56. Patent 12,025,618 expires

    Published Purple Book patent expiration.

    in 13 yr 5 mo

  57. Patent 11,744,950 expires

    Published Purple Book patent expiration.

    in 13 yr 8 mo

  58. Patent 12,059,555 expires

    Published Purple Book patent expiration.

    in 14 yr 6 mo

Biosimilars & interchangeables for denosumab

11 FDA-licensed follow-on biologics referencing denosumab.

Biosimilars and interchangeable biosimilars referencing denosumab.
ProductProper nameApplicantTypeBLAApproved
Jubbontidenosumab-bbdzSandoz Inc.Interchangeable761362Mar 05, 2024
Ospomyvdenosumab-dssbSamsung Bioepis Co., Ltd.Interchangeable761392Feb 13, 2025
Osenveltdenosumab-bmwoCELLTRION, Inc.Interchangeable761404Feb 28, 2025
Bomyntradenosumab-bnhtFresenius Kabi USA, LLCInterchangeable761398Mar 25, 2025
Bildyosdenosumab-nxxpShanghai Henlius Biotech, Inc.Interchangeable761444Aug 29, 2025
Aukelsodenosumab-kyqqBiocon Biologics Inc.Interchangeable761436Sep 16, 2025
Enobydenosumab-qbdeHikma Pharmaceuticals USA Inc.Interchangeable761439Sep 26, 2025
Jubereqdenosumab-desuAccord BioPharma Inc.Interchangeable761424Oct 29, 2025
Boncresadenosumab-mobzAmneal Pharmaceuticals LLCInterchangeable761456Dec 19, 2025
Oziltusdenosumab-mobzAmneal Pharmaceuticals LLCInterchangeable761457Dec 19, 2025
Ponlimsidenosumab-adetTeva Pharmaceuticals, Inc.Interchangeable761385Mar 27, 2026

Published patents

Patents the BLA holder has published in the FDA Purple Book Patent List for denosumab.

Published Purple Book patents for denosumab.
PatentExpiresIn
8,058,418Nov 30, 20232 yr 6 mo ago
7,364,736Feb 19, 20251 yr 4 mo ago
7,427,659Mar 15, 20251 yr 3 mo ago
8,247,210Dec 06, 2026in 6 mo
8,460,896Dec 06, 2026in 6 mo
8,680,248Dec 06, 2026in 6 mo
8,217,153Jan 05, 2027in 7 mo
7,928,205Feb 12, 2027in 9 mo
7,888,101Apr 06, 2027in 10 mo
7,662,930Apr 24, 2027in 11 mo
9,359,435May 22, 2027in 1 yr
8,053,236Jan 19, 2030in 3 yr 8 mo
9,228,168Jan 19, 2030in 3 yr 8 mo
9,320,816Nov 14, 2030in 4 yr 6 mo
9,012,178Aug 05, 2031in 5 yr 3 mo
9,133,493Apr 20, 2032in 6 yr
9,388,447Apr 20, 2032in 6 yr
11,292,829Jun 29, 2032in 6 yr 2 mo
11,634,476Jun 29, 2032in 6 yr 2 mo
11,685,772Jun 29, 2032in 6 yr 2 mo
9,371,554Dec 14, 2032in 6 yr 8 mo
11,293,930Mar 26, 2033in 6 yr 11 mo
11,486,883Mar 26, 2033in 6 yr 11 mo
9,328,134Feb 20, 2034in 7 yr 10 mo
11,319,568Mar 10, 2034in 7 yr 11 mo
11,459,595Mar 10, 2034in 7 yr 11 mo
11,952,605Mar 10, 2034in 7 yr 11 mo
12,084,686Mar 10, 2034in 7 yr 11 mo
11,492,372Mar 11, 2034in 7 yr 11 mo
10,421,987May 29, 2034in 8 yr 1 mo
10,894,972May 29, 2034in 8 yr 1 mo
11,434,514May 29, 2034in 8 yr 1 mo
11,946,085May 29, 2034in 8 yr 1 mo
9,481,901May 29, 2034in 8 yr 1 mo
9,803,166Sep 29, 2034in 8 yr 5 mo
11,299,760Oct 30, 2034in 8 yr 6 mo
10,513,723Dec 09, 2034in 8 yr 8 mo
11,254,963Dec 09, 2034in 8 yr 8 mo
10,106,829Dec 11, 2034in 8 yr 8 mo
10,227,627Dec 11, 2034in 8 yr 8 mo
10,655,156Dec 11, 2034in 8 yr 8 mo
10,907,186Dec 11, 2034in 8 yr 8 mo
11,130,980Apr 05, 2035in 9 yr
11,077,404May 13, 2035in 9 yr 1 mo
11,384,378Jun 04, 2035in 9 yr 2 mo
11,427,848Jun 04, 2035in 9 yr 2 mo
10,583,397Jul 28, 2035in 9 yr 3 mo
11,786,866Oct 21, 2035in 9 yr 6 mo
11,192,919Nov 13, 2035in 9 yr 7 mo
10,167,492Dec 01, 2035in 9 yr 8 mo
10,822,630Dec 01, 2035in 9 yr 8 mo
11,275,090Jul 02, 2037in 11 yr 3 mo
11,098,079Jul 21, 2037in 11 yr 4 mo
9,881,367Aug 09, 2037in 11 yr 4 mo
12,025,618Aug 26, 2039in 13 yr 5 mo
11,744,950Nov 21, 2039in 13 yr 8 mo
12,059,555Sep 02, 2040in 14 yr 6 mo

Frequently asked questions

What biosimilars are approved for denosumab (Prolia)?

The FDA Purple Book lists 11 approved follow-on biologics referencing denosumab: Jubbonti, Ospomyv, Osenvelt, Bomyntra, Bildyos, Aukelso, Enoby, Jubereq, Boncresa, Oziltus, and Ponlimsi. Of these, 11 are interchangeable biosimilars and 0 are 351(k) biosimilars.

Is there an interchangeable biosimilar for denosumab?

Yes. Jubbonti, Ospomyv, Osenvelt, Bomyntra, Bildyos, Aukelso, Enoby, Jubereq, Boncresa, Oziltus, and Ponlimsi are approved as interchangeable biosimilars for denosumab, meaning they may be substituted for the reference product at the pharmacy without prescriber involvement, subject to state law.

Who makes denosumab biosimilars?

Companies with FDA-approved follow-on biologics referencing denosumab include Sandoz Inc., Samsung Bioepis Co., Ltd., CELLTRION, Inc., Fresenius Kabi USA, LLC, Shanghai Henlius Biotech, Inc., Biocon Biologics Inc., Hikma Pharmaceuticals USA Inc., Accord BioPharma Inc., Amneal Pharmaceuticals LLC, and Teva Pharmaceuticals, Inc..

How many patents are listed for denosumab (Prolia) in the Purple Book?

57 patents are published in the FDA Purple Book Patent List for denosumab.

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