FDA.reportPublic FDA data

Prolia Purple Book BLA 125320

BLA number
125320
Proprietary names
Prolia, Xgeva
Proper names
denosumab
Applicant
Amgen Inc.
Center
CDER
First observed release
2020-05-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
57 patents listed; source updated 2025-06-11
Coverage
Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001Proliadenosumab351(a)60MG/MLInjectionSubcutaneousPre-Filled SyringeRxLicensed2010-06-01YES
002Proliadenosumab351(a)60MG/MLInjectionSubcutaneousSingle-Dose VialDiscLicensed2010-06-01YES
003Xgevadenosumab351(a)120MG/1.7ML (70MG/ML)InjectionSubcutaneousSingle-Dose VialRxLicensed2010-11-18YES

Biosimilar And Interchangeable Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761362Jubbontidenosumab-bbdz351(k) InterchangeableRx2026-06-01
761385Ponlimsidenosumab-adet351(k) InterchangeableRx2026-06-01
761392Ospomyvdenosumab-dssb351(k) InterchangeableRx2026-06-01
761398Conexxencedenosumab-bnht351(k) InterchangeableRx2026-06-01
761404Stoboclodenosumab-bmwo351(k) InterchangeableRx2026-06-01
761424Osvyrtidenosumab-desu351(k) InterchangeableRx2026-06-01
761436Bosayadenosumab-kyqq351(k) InterchangeableRx2026-06-01
761439Enobydenosumab-qbde351(k) InterchangeableRx2026-06-01
761444Bildyosdenosumab-nxxp351(k) InterchangeableRx2026-06-01
761456Boncresadenosumab-mobz351(k) InterchangeableRx2026-06-01
761457Oziltusdenosumab-mobz351(k) InterchangeableRx2026-06-01

Published Patent List#

Patent, Expiration, Source updated table
PatentExpirationSource updated
12,059,5552040-09-022025-06-11
11,744,9502039-11-212025-06-11
12,025,6182039-08-262025-06-11
9,881,3672037-08-092025-06-11
11,098,0792037-07-212025-06-11
11,275,0902037-07-022025-06-11
10,167,4922035-12-012025-06-11
10,822,6302035-12-012025-06-11
11,192,9192035-11-132025-06-11
11,786,8662035-10-212025-06-11
10,583,3972035-07-282025-06-11
11,384,3782035-06-042025-06-11
11,427,8482035-06-042025-06-11
11,077,4042035-05-132025-06-11
11,130,9802035-04-052025-06-11
10,106,8292034-12-112025-06-11
10,227,6272034-12-112025-06-11
10,655,1562034-12-112025-06-11
10,907,1862034-12-112025-06-11
10,513,7232034-12-092025-06-11
11,254,9632034-12-092025-06-11
11,299,7602034-10-302025-06-11
9,803,1662034-09-292025-06-11
10,421,9872034-05-292025-06-11
10,894,9722034-05-292025-06-11
11,434,5142034-05-292025-06-11
11,946,0852034-05-292025-06-11
9,481,9012034-05-292025-06-11
11,492,3722034-03-112025-06-11
11,319,5682034-03-102025-06-11
11,459,5952034-03-102025-06-11
11,952,6052034-03-102025-06-11
12,084,6862034-03-102025-06-11
9,328,1342034-02-202025-06-11
11,293,9302033-03-262025-06-11
11,486,8832033-03-262025-06-11
9,371,5542032-12-142025-06-11
11,292,8292032-06-292025-06-11
11,634,4762032-06-292025-06-11
11,685,7722032-06-292025-06-11
9,133,4932032-04-202025-06-11
9,388,4472032-04-202025-06-11
9,012,1782031-08-052025-06-11
9,320,8162030-11-142025-06-11
8,053,2362030-01-192025-06-11
9,228,1682030-01-192025-06-11
9,359,4352027-05-222025-06-11
7,662,9302027-04-242025-06-11
7,888,1012027-04-062025-06-11
7,928,2052027-02-122025-06-11
8,217,1532027-01-052025-06-11
8,247,2102026-12-062025-06-11
8,460,8962026-12-062025-06-11
8,680,2482026-12-062025-06-11
7,427,6592025-03-152025-06-11
7,364,7362025-02-192025-06-11
8,058,4182023-11-302025-06-11

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2023-03-01U001Prolia351(a)RxAmgen Inc.
2023-03-01U002Prolia351(a)DiscAmgen Inc.
2023-03-01U003Xgeva351(a)RxAmgen Inc.
2023-01-01U002Prolia351(a)DiscAmgen Inc.
2020-08-01U003Xgeva351(a)RxAmgen Inc.
2020-05-01R001Prolia351(a)RxAmgen Inc.
2020-05-01R002Prolia351(a)DiscAmgen Inc.
2020-05-01R003Xgeva351(a)RxAmgen Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2023-01-01002Prolia351(a)DiscLicensed2010-06-01
2020-05-01001Prolia351(a)RxLicensed2010-06-01
2020-05-01002Prolia351(a)DiscVoluntarily Revoked2010-06-01
2020-05-01003Xgeva351(a)RxLicensed2010-11-18