Purple Book product · Reference 351(a)

Prolia

denosumab

351(a)BLA 125320RxLicensed Amgen Inc.

View denosumab family Label PDF Open on FDA Purple Book

Jun 01, 2010

Approved

Reference 351(a)

License type

Marketing

Listed patents

Prolia (denosumab) is Amgen Inc.'s FDA-licensed reference biologic, approved under a 351(a) BLA in 2010. The FDA Purple Book lists 57 published patents for it, the last expiring 2040. 20 approved follow-on biologics reference Prolia (Xgeva, Jubbonti, Wyost, Ospomyv, Xbryk, Stoboclo, Osenvelt, Conexxence, Bomyntra, Bildyos, Bilprevda, Bosaya, Aukelso, Enoby, Xtrenbo, Osvyrti, Jubereq, Oziltus, Boncresa, and Ponlimsi).

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Approval
Approval date of this BLA submission.
Jun 01, 2010
16 yr 4 mo ago
Today

Pharmaceutical detail

Strength

60MG/ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Pre-Filled Syringe

Center

CDER

License number

1080

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. Its approved biosimilars and interchangeables are listed below.

1 additional BLA record for this product (other strengths or presentations) are in the same reference family.

Patent list (57)

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
Patent	Expires	In	Source
8,058,418	Nov 30, 2023	2 yr 8 mo ago	FDA
7,364,736	Feb 19, 2025	1 yr 5 mo ago	FDA
7,427,659	Mar 15, 2025	1 yr 4 mo ago	FDA
8,247,210	Dec 06, 2026	in 5 mo	FDA
8,460,896	Dec 06, 2026	in 5 mo	FDA
8,680,248	Dec 06, 2026	in 5 mo	FDA
8,217,153	Jan 05, 2027	in 6 mo	FDA
7,928,205	Feb 12, 2027	in 7 mo	FDA
7,888,101	Apr 06, 2027	in 9 mo	FDA
7,662,930	Apr 24, 2027	in 9 mo	FDA
9,359,435	May 22, 2027	in 10 mo	FDA
8,053,236	Jan 19, 2030	in 3 yr 7 mo	FDA
9,228,168	Jan 19, 2030	in 3 yr 7 mo	FDA
9,320,816	Nov 14, 2030	in 4 yr 5 mo	FDA
9,012,178	Aug 05, 2031	in 5 yr 1 mo	FDA
9,133,493	Apr 20, 2032	in 5 yr 10 mo	FDA
9,388,447	Apr 20, 2032	in 5 yr 10 mo	FDA
11,292,829	Jun 29, 2032	in 6 yr	FDA
11,634,476	Jun 29, 2032	in 6 yr	FDA
11,685,772	Jun 29, 2032	in 6 yr	FDA
9,371,554	Dec 14, 2032	in 6 yr 6 mo	FDA
11,293,930	Mar 26, 2033	in 6 yr 9 mo	FDA
11,486,883	Mar 26, 2033	in 6 yr 9 mo	FDA
9,328,134	Feb 20, 2034	in 7 yr 8 mo	FDA
11,319,568	Mar 10, 2034	in 7 yr 9 mo	FDA
11,459,595	Mar 10, 2034	in 7 yr 9 mo	FDA
11,952,605	Mar 10, 2034	in 7 yr 9 mo	FDA
12,084,686	Mar 10, 2034	in 7 yr 9 mo	FDA
11,492,372	Mar 11, 2034	in 7 yr 9 mo	FDA
10,421,987	May 29, 2034	in 8 yr	FDA
10,894,972	May 29, 2034	in 8 yr	FDA
11,434,514	May 29, 2034	in 8 yr	FDA
11,946,085	May 29, 2034	in 8 yr	FDA
9,481,901	May 29, 2034	in 8 yr	FDA
9,803,166	Sep 29, 2034	in 8 yr 4 mo	FDA
11,299,760	Oct 30, 2034	in 8 yr 5 mo	FDA
10,513,723	Dec 09, 2034	in 8 yr 6 mo	FDA
11,254,963	Dec 09, 2034	in 8 yr 6 mo	FDA
10,106,829	Dec 11, 2034	in 8 yr 6 mo	FDA
10,227,627	Dec 11, 2034	in 8 yr 6 mo	FDA
10,655,156	Dec 11, 2034	in 8 yr 6 mo	FDA
10,907,186	Dec 11, 2034	in 8 yr 6 mo	FDA
11,130,980	Apr 05, 2035	in 8 yr 10 mo	FDA
11,077,404	May 13, 2035	in 8 yr 11 mo	FDA
11,384,378	Jun 04, 2035	in 9 yr	FDA
11,427,848	Jun 04, 2035	in 9 yr	FDA
10,583,397	Jul 28, 2035	in 9 yr 2 mo	FDA
11,786,866	Oct 21, 2035	in 9 yr 5 mo	FDA
11,192,919	Nov 13, 2035	in 9 yr 5 mo	FDA
10,167,492	Dec 01, 2035	in 9 yr 6 mo	FDA
10,822,630	Dec 01, 2035	in 9 yr 6 mo	FDA
11,275,090	Jul 02, 2037	in 11 yr 1 mo	FDA
11,098,079	Jul 21, 2037	in 11 yr 2 mo	FDA
9,881,367	Aug 09, 2037	in 11 yr 3 mo	FDA
12,025,618	Aug 26, 2039	in 13 yr 4 mo	FDA
11,744,950	Nov 21, 2039	in 13 yr 6 mo	FDA
12,059,555	Sep 02, 2040	in 14 yr 4 mo	FDA

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

Change history

v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

When do Prolia's patents expire?

The FDA Purple Book lists 57 published patents for Prolia, with the last listed patent expiring Sep 02, 2040. Every patent below links to its FDA source record so you can verify the expiration date.

Does Prolia have approved biosimilars?

Yes. 20 approved follow-on biologics reference Prolia in the Purple Book: Xgeva, Jubbonti, Wyost, Ospomyv, Xbryk, Stoboclo, Osenvelt, Conexxence, Bomyntra, Bildyos, Bilprevda, Bosaya, Aukelso, Enoby, Xtrenbo, Osvyrti, Jubereq, Oziltus, Boncresa, and Ponlimsi.

What is Prolia's BLA number?

Prolia is licensed under BLA 125320, held by Amgen Inc..

When was Prolia approved by the FDA?

Prolia was approved by the FDA on Jun 01, 2010.

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