What is Tyenne in the FDA Purple Book?

Tyenne, BLA 761449, is listed as a 351(k) biosimilar 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 761449?

Tyenne, BLA 761449, lists Fresenius Kabi USA, LLC 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 Tyenne?

Tyenne, BLA 761449, 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 Tyenne's reference-product relationship?

Tyenne, BLA 761449, lists Actemra 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.

Is Tyenne interchangeable?

Tyenne, BLA 761449, is a biosimilar without an interchangeability designation in the loaded Purple Book record. Biosimilar status alone does not establish automatic pharmacy substitution, and this page does not infer interchangeability from shared names, strengths, or routes.

When was Tyenne licensed by FDA?

Tyenne, BLA 761449, has a listed FDA approval date of Mar 14, 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 Tyenne's FDA label?

Tyenne, BLA 761449, 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 Tyenne?

Tyenne, BLA 761449, has 35 published Purple Book patent rows, with the latest listed expiration on Jul 31, 2035. 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 Tyenne?

Tyenne, BLA 761449, 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 · Biosimilar 351(k)

Tyenne

tocilizumab-aazg

Tyenne, BLA 761449, is listed in the FDA Purple Book as a 351(k) biosimilar. This page consolidates 2 exact FDA presentation rows, and FDA names Actemra 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) BiosimilarBLA 761449 2 presentationsRxLicensed Fresenius Kabi USA, LLC

Approved

Mar 14, 2025

License type

351(k) Biosimilar

Marketing

Listed patents

Tyenne (tocilizumab-aazg) is a Biosimilar 351(k) referencing tocilizumab, licensed under a 351(k) BLA in 2025; the Purple Book lists Fresenius Kabi USA, LLC as the BLA applicant, not necessarily the manufacturer or commercial supplier. The Purple Book lists 35 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

761449

Regulatory role

351(k) biosimilar

Applicant

Fresenius Kabi USA, LLC

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Mar 14, 2025

Reference product

Actemra

Tyenne is an FDA-licensed biosimilar without an interchangeability designation in this record.

Tyenne was licensed through the 351(k) pathway as biosimilar to Actemra.

Substitution boundary

Biosimilar status alone is not an FDA interchangeability designation and does not establish automatic pharmacy substitution.

Key dates

Licensure & exclusivity

Approval
Approval date of this BLA submission.
Mar 14, 2025
1 yr 7 mo ago
Today

Strengths & presentations

2 FDA presentation rows · BLA 761449

Strength

162MG/0.9ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Pre-Filled Syringe

Center

CDER

License number

2146

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	162MG/0.9ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
002	162MG/0.9ML	Injection	Subcutaneous	Autoinjector	Licensed	Rx

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

Tyenne names Actemra 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 Actemra

TyenneBiosimilar 351(k)
tocilizumab-aazg · Fresenius Kabi USA, LLC
2024

Reference-family comparison

Purple Book comparison of products in this reference family
Product	Designation	BLA	Approved	Presentation	Marketing
Actemratocilizumab	351(a) ambiguous reference candidate	125276	Jan 08, 2010	80MG/4ML (20MG/ML) · Intravenous	Rx
Actemratocilizumab	351(a) ambiguous reference candidate	125472	Oct 21, 2013	162MG/0.9ML · Subcutaneous	Rx
Tyennetocilizumab-aazg	351(k) biosimilar	761449	Mar 14, 2025	162MG/0.9ML · Subcutaneous	Rx
Tyennetocilizumab-aazg	351(k) biosimilar	761275	Mar 05, 2024	80MG/4ML (20MG/ML) · Intravenous	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
7,332,289	Aug 04, 2023	3 yr 2 mo ago	FDA
10,744,201	Apr 28, 2024	2 yr 5 mo ago	FDA
7,521,052	Apr 28, 2024	2 yr 5 mo ago	FDA
8,709,409	Jun 22, 2024	2 yr 3 mo ago	FDA
8,734,800	Mar 24, 2025	1 yr 6 mo ago	FDA
9,902,777	May 28, 2025	1 yr 4 mo ago	FDA
8,617,550	Mar 03, 2026	7 mo ago	FDA
8,398,980	Feb 25, 2028	in 1 yr 5 mo	FDA
11,078,294	Jul 08, 2028	in 1 yr 10 mo	FDA
8,574,869	Jul 08, 2028	in 1 yr 10 mo	FDA
11,008,394	Dec 26, 2028	in 2 yr 4 mo	FDA
11,359,026	Dec 26, 2028	in 2 yr 4 mo	FDA
11,584,798	Dec 26, 2028	in 2 yr 4 mo	FDA
11,136,375	Jul 19, 2029	in 2 yr 10 mo	FDA
8,568,720	Nov 05, 2029	in 3 yr 2 mo	FDA
10,982,003	Aug 06, 2030	in 3 yr 11 mo	FDA
9,714,293	Aug 06, 2030	in 3 yr 11 mo	FDA
10,501,769	Oct 25, 2030	in 4 yr 2 mo	FDA
11,021,728	Oct 25, 2030	in 4 yr 2 mo	FDA
11,136,610	Oct 25, 2030	in 4 yr 2 mo	FDA
11,377,678	Oct 25, 2030	in 4 yr 2 mo	FDA
8,512,983	Jan 04, 2031	in 4 yr 4 mo	FDA
10,662,237	Aug 07, 2031	in 4 yr 11 mo	FDA
11,667,720	Nov 07, 2031	in 5 yr 2 mo	FDA
8,580,264	Nov 07, 2031	in 5 yr 2 mo	FDA
10,231,981	Dec 03, 2031	in 5 yr 3 mo	FDA
10,874,677	Mar 02, 2032	in 5 yr 6 mo	FDA
9,539,263	May 23, 2032	in 5 yr 9 mo	FDA
9,750,752	Aug 30, 2032	in 6 yr	FDA
10,590,164	Mar 19, 2033	in 6 yr 7 mo	FDA
9,630,988	Jun 13, 2033	in 6 yr 10 mo	FDA
10,676,710	Mar 14, 2034	in 7 yr 7 mo	FDA
10,829,732	Mar 14, 2034	in 7 yr 7 mo	FDA
10,017,732	Dec 25, 2034	in 8 yr 5 mo	FDA
10,336,983	Jul 31, 2035	in 9 yr	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

Fresenius Kabi USA, LLC 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

Tyenne is an FDA-licensed biosimilar without an interchangeability designation in this record. 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

Tyenne: 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.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo