What is Prolia in the FDA Purple Book?

Prolia, BLA 125320, is listed as a 351(a) reference biologic with 2 exact FDA presentation rows. The page preserves the BLA-level regulatory role and does not substitute clinical, inventory, or legal conclusions for the source record.

Who is responsible for BLA 125320?

Prolia, BLA 125320, lists Amgen Inc. as the BLA applicant. The applicant field identifies responsibility for the application; it does not, by itself, prove that the organization physically manufactures, labels, distributes, or currently sells every presentation.

What presentations are listed for Prolia?

Prolia, BLA 125320, has 2 exact FDA presentation rows consolidated on this page. Strength, dosage form, route, product number, licensure, and marketing fields remain attached to their own row rather than being merged into disconnected lists.

What is Prolia's reference-product relationship?

Prolia, BLA 125320, is supported as a reference biologic by exact-BLA evidence and has 19 name-linked 351(k) follow-on products in the loaded snapshot. This answer is limited to the current FDA Purple Book record and its exact BLA-level fields.

Is Prolia interchangeable?

Prolia, BLA 125320, is not presented as an interchangeable product. Interchangeability is an FDA designation attached to an individual 351(k) follow-on, not a property inferred from this 351(a) BLA or its family.

When was Prolia licensed by FDA?

Prolia, BLA 125320, has a listed FDA approval date of Jun 01, 2010. The date is reproduced from this exact Purple Book BLA record and is not a statement about commercial launch or current availability.

Does this page summarize Prolia's FDA label?

Prolia, BLA 125320, No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research. Therefore the page does not publish product-specific approved uses, dosing, boxed warnings, or safety claims from a reference product or same-ingredient document.

What patent information is published for Prolia?

Prolia, BLA 125320, has 57 published Purple Book patent rows, with the latest listed expiration on Sep 02, 2040. FDA publishes sponsor-provided patent information ministerially; these rows are not conclusions about validity, infringement, freedom to operate, or market entry.

What exclusivity information is listed for Prolia?

Prolia, BLA 125320, has no populated exclusivity date in the loaded Purple Book row. Missing database fields do not prove that no regulatory or legal constraints exist, and this page does not calculate a market-entry date.

FDA Purple Book product · 351(a) biologic

Prolia

denosumab

Prolia, BLA 125320, is listed in the FDA Purple Book as a 351(a) reference biologic. This page consolidates 2 exact FDA presentation rows, and 19 FDA rows name-link 351(k) follow-on products to its reference family. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.

351(a)BLA 125320 2 presentationsRxLicensed Amgen Inc.

Approved

Jun 01, 2010

License type

351(a)

Marketing

Listed patents

Prolia (denosumab) is Amgen Inc.'s FDA-licensed 351(a) biologic under BLA 125320, approved in 2010. The FDA Purple Book lists 57 published patents for it, the last expiring 2040. 19 distinct approved follow-on biologics explicitly reference Prolia (Jubbonti, Wyost, Ospomyv, Xbryk, Stoboclo, Osenvelt, Conexxence, Bomyntra, Bildyos, Bilprevda, Bosaya, Aukelso, Enoby, Xtrenbo, Osvyrti, Jubereq, Boncresa, Oziltus, and Ponlimsi), making its reference-product role visible in the loaded family data.

Sourced from the FDA Purple Book · verified Aug 11, 2026

What this Purple Book record establishes

Regulatory interpretation

BLA number

125320

Regulatory role

351(a) reference biologic

Applicant

Amgen Inc.

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Jun 01, 2010

Follow-on biologics

Prolia is a 351(a) reference biologic supported by exact-BLA evidence.

19 distinct licensed follow-on biologics in the loaded Purple Book data name Prolia as their reference product; exact-BLA patent or exclusivity fields, or an unambiguous single-BLA name match, support this page's role.

Substitution boundary

Substitution status belongs to an individual follow-on product; it cannot be inferred from the reference product alone.

Key dates

Licensure & exclusivity

Approval
Approval date of this BLA submission.
Jun 01, 2010
16 yr 7 mo ago
Today

Strengths & presentations

2 FDA presentation rows · BLA 125320

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

Exact presentation matrix

One row per FDA presentation under this exact BLA. Missing cells remain unavailable rather than being borrowed from another product.

Exact FDA Purple Book presentation rows for this BLA
Product	Strength	Dosage form	Route	Presentation	Licensure	Marketing
001	60MG/ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
002	60MG/ML	Injection	Subcutaneous	Single-Dose Vial	Licensed	Disc

Other brands under BLA 125320

The rows above are this brand's presentations. FDA also lists the brand below on this BLA, each with its own presentation rows. Strength and reference product come from each brand's own rows; a shared BLA does not establish shared presentations, approved uses, or substitutability.

Xgeva
denosumab · Strength: 120MG/1.7ML (70MG/ML)

Exact-source evidence coverage

Labeling & approval review

Current product label

Exact-source research required

No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research.

FDA approval evidence

Not applicable to 351(a)

A biosimilar totality-of-evidence summary is not applicable to this 351(a) record. Product-specific clinical content still requires an exact-BLA label or review source.

Human review pending

Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 1 exact-source task. Labeling and approval-review claims stay unavailable until their own match gate passes.

Reference product family

Biosimilars & interchangeables

View full family

19 distinct 351(k) follow-on biologics are linked through FDA-stated reference names to Prolia; 19 are designated interchangeable and 19 have a licensed status in the loaded snapshot.

Exact-BLA patent, exclusivity, or unambiguous linked-family evidence supports this page's reference role. Name-linked licensed biosimilars and interchangeables are listed below.

Reference-family comparison

Purple Book comparison of products in this reference family
Product	Designation	BLA	Approved	Presentation	Marketing
Proliadenosumab	351(a) reference biologic	125320	Jun 01, 2010	60MG/ML · Subcutaneous	Rx
Jubbontidenosumab-bbdz	351(k) interchangeable biosimilar	761362	Mar 05, 2024	60MG/ML · Subcutaneous	Rx
Wyostdenosumab-bbdz	351(k) interchangeable biosimilar	761362	Mar 05, 2024	120MG/1.7ML (70MG/ML) · Subcutaneous	Rx
Ospomyvdenosumab-dssb	351(k) interchangeable biosimilar	761392	Feb 13, 2025	60MG/ML · Subcutaneous	Rx
Xbrykdenosumab-dssb	351(k) interchangeable biosimilar	761392	Feb 13, 2025	120MG/1.7ML (70MG/ML) · Subcutaneous	Rx
Stoboclodenosumab-bmwo	351(k) interchangeable biosimilar	761404	Feb 28, 2025	60MG/ML · Subcutaneous	Rx
Osenveltdenosumab-bmwo	351(k) interchangeable biosimilar	761404	Feb 28, 2025	120MG/1.7ML (70MG/ML) · Subcutaneous	Rx
Conexxencedenosumab-bnht	351(k) interchangeable biosimilar	761398	Mar 25, 2025	60MG/ML · Subcutaneous	Rx
Bomyntradenosumab-bnht	351(k) interchangeable biosimilar	761398	Mar 25, 2025	120MG/1.7ML (70MG/ML) · Subcutaneous	Rx
Bildyosdenosumab-nxxp	351(k) interchangeable biosimilar	761444	Aug 29, 2025	60MG/ML · Subcutaneous	Rx
Bilprevdadenosumab-nxxp	351(k) interchangeable biosimilar	761444	Aug 29, 2025	120MG/1.7ML (70MG/ML) · Subcutaneous	Rx
Bosayadenosumab-kyqq	351(k) interchangeable biosimilar	761436	Sep 16, 2025	60MG/ML · Subcutaneous	Rx
Aukelsodenosumab-kyqq	351(k) interchangeable biosimilar	761436	Sep 16, 2025	120MG/1.7ML (70MG/ML) · Subcutaneous	Rx
Enobydenosumab-qbde	351(k) interchangeable biosimilar	761439	Sep 26, 2025	60MG/ML · Subcutaneous	Rx
Xtrenbodenosumab-qbde	351(k) interchangeable biosimilar	761439	Sep 26, 2025	120MG/1.7ML (70MG/ML) · Subcutaneous	Rx
Osvyrtidenosumab-desu	351(k) interchangeable biosimilar	761424	Oct 29, 2025	60MG/ML · Subcutaneous	Rx
Jubereqdenosumab-desu	351(k) interchangeable biosimilar	761424	Oct 29, 2025	120MG/1.7ML (70MG/ML) · Subcutaneous	Rx
Boncresadenosumab-mobz	351(k) interchangeable biosimilar	761456	Dec 19, 2025	60MG/ML · Subcutaneous	Rx
Oziltusdenosumab-mobz	351(k) interchangeable biosimilar	761457	Dec 19, 2025	120MG/1.7ML (70MG/ML) · Subcutaneous	Rx
Ponlimsidenosumab-adet	351(k) interchangeable biosimilar	761385	Mar 27, 2026	60MG/ML · Subcutaneous	Rx

Published patents

BPCIA patent list

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

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

2 exact FDA presentation rows are consolidated under this BLA rather than split across duplicate pages.

Administration fields

The loaded rows list Subcutaneous and Injection; these are regulatory presentation fields, not dosing instructions.

Applicant boundary

Amgen Inc. is the listed BLA applicant. The page does not relabel the applicant as manufacturer, labeler, distributor, or commercial supplier without an exact product-specific source.

Regulatory comparison

Prolia is a 351(a) reference biologic supported by exact-BLA evidence. Family comparisons preserve each BLA's own designation and do not use Orange Book therapeutic-equivalence terminology.

Source provenance

FDA Purple Book data

Source kind · Monthly download

Checked Aug 11, 2026

FDA release · June 2026

FDA source FDA source

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

What this record does not establish

Purple Book marketing status is a regulatory field, not real-time commercial inventory or launch status.
The listed applicant or BLA holder is not automatically the product’s physical manufacturer, labeler, or distributor.
Biosimilar status and interchangeability are distinct FDA designations; neither is a therapeutic-equivalence code from the Orange Book.
A missing patent or exclusivity row is not proof that no relevant rights exist, and listed patent information is not a freedom-to-operate opinion.
Approved uses, dosing, warnings, and clinical evidence require the exact current product label or approval package and are not inferred from the reference product.

Change history

Record versions

v5Aug 11, 2026
v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Prolia: frequently asked questions

Licensure, biosimilar status, exclusivity, and patents for this biologic, from the FDA Purple Book.

Built directly from the FDA Purple Book database of licensed biological products. License types, approval and exclusivity dates, and the patent list match the official FDA record. The Purple Book patent list reflects the statutory BPCIA patent exchange and is not exhaustive.

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