What is Aukelso in the FDA Purple Book?

Aukelso, BLA 761436, is listed as a 351(k) interchangeable biosimilar with 1 exact FDA presentation row. 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 761436?

Aukelso, BLA 761436, lists Biocon Biologics 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 Aukelso?

Aukelso, BLA 761436, has 1 exact FDA presentation row 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 Aukelso's reference-product relationship?

Aukelso, BLA 761436, lists Xgeva as its FDA reference product. The loaded row does not supply a reference BLA number, so this page does not invent one from a name match.

When was Aukelso licensed by FDA?

Aukelso, BLA 761436, has a listed FDA approval date of Sep 16, 2025. 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 Aukelso's FDA label?

Aukelso, BLA 761436, 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 Aukelso?

Aukelso, BLA 761436, 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 Aukelso?

Aukelso, BLA 761436, 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 · Interchangeable

Aukelso

denosumab-kyqq

Aukelso, BLA 761436, is listed in the FDA Purple Book as a 351(k) interchangeable biosimilar. This page consolidates 1 exact FDA presentation row, and FDA names Xgeva as its reference product. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.

351(k) InterchangeableBLA 761436RxLicensed Biocon Biologics Inc.

Approved

Sep 16, 2025

License type

351(k) Interchangeable

Marketing

Listed patents

Aukelso (denosumab-kyqq) is a Interchangeable referencing denosumab, licensed under a 351(k) BLA in 2025; the Purple Book lists Biocon Biologics Inc. as the BLA applicant, not necessarily the manufacturer or commercial supplier. Its interchangeable biosimilar designation may permit pharmacy-level substitution for the reference product without prescriber intervention, subject to state law; it is not a superiority claim. The Purple Book lists 57 published patents for this product.

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

What this Purple Book record establishes

Regulatory interpretation

BLA number

761436

Regulatory role

351(k) interchangeable biosimilar

Applicant

Biocon Biologics Inc.

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Sep 16, 2025

Reference product

Xgeva

Aukelso is an FDA-designated interchangeable biosimilar.

Aukelso is a 351(k) biosimilar of Xgeva and carries an interchangeability designation.

Substitution boundary

An interchangeable designation may permit pharmacy-level substitution for the reference product without prescriber intervention, depending on state pharmacy law; it is not a claim of clinical superiority.

Key dates

Licensure & exclusivity

Approval
Approval date of this BLA submission.
Sep 16, 2025
1 yr ago
Today

Pharmaceutical detail

FDA product record

Strength

120MG/1.7ML (70MG/ML)

Dosage form

Injection

Route

Subcutaneous

Presentation

Single-Dose Vial

Center

CDER

License number

2324

Product number

002

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
002	120MG/1.7ML (70MG/ML)	Injection	Subcutaneous	Single-Dose Vial	Licensed	Rx

Other brands under BLA 761436

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.

Bosaya
denosumab-kyqq · Reference product: Prolia · Strength: 60MG/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

Exact-source research required

No independently matched exact-BLA FDA approval letter or review package is stored, so product-specific biosimilarity or switching evidence is not summarized.

Human review pending

Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 2 exact-source tasks. Labeling and approval-review claims stay unavailable until their own match gate passes.

Reference product family

Biosimilars & interchangeables

View full family

Aukelso names Xgeva as its reference product. The comparison below shows locally matched BLA candidates and follow-ons; it does not invent a reference BLA number when FDA did not state one in the loaded row.

Biosimilar of Xgeva

Reference-family comparison

Purple Book comparison of products in this reference family
Product	Designation	BLA	Approved	Presentation	Marketing
Proliadenosumab	351(a) name-matched reference candidate	125320	Jun 01, 2010	60MG/ML · Subcutaneous	Rx
Aukelsodenosumab-kyqq	351(k) interchangeable biosimilar	761436	Sep 16, 2025	120MG/1.7ML (70MG/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

1 exact FDA presentation row is 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

Biocon Biologics 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

Aukelso is an FDA-designated interchangeable biosimilar. 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

v4Aug 11, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Aukelso: 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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