Purple Book product · Biosimilar 351(k)

Tyenne

tocilizumab-aazg

351(k) BiosimilarBLA 761275RxLicensed Fresenius Kabi USA, LLC

View tocilizumab family Label PDF Open on FDA Purple Book

Mar 05, 2024

Approved

Biosimilar 351(k)

License type

Marketing

Listed patents

Tyenne (tocilizumab-aazg) is a Biosimilar 351(k) referencing tocilizumab, licensed under a 351(k) BLA in 2024 and marketed by Fresenius Kabi USA, LLC. The Purple Book lists 35 published patents for this product.

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

Key dates

Approval
Approval date of this BLA submission.
Mar 05, 2024
2 yr 5 mo ago
Today

Pharmaceutical detail

Strength

400MG/20ML (20MG/ML)

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CDER

License number

2146

Product number

003

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

Biosimilar of tocilizumab (Actemra)

Patent list (35)

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 ago	FDA
10,744,201	Apr 28, 2024	2 yr 3 mo ago	FDA
7,521,052	Apr 28, 2024	2 yr 3 mo ago	FDA
8,709,409	Jun 22, 2024	2 yr 1 mo ago	FDA
8,734,800	Mar 24, 2025	1 yr 4 mo ago	FDA
9,902,777	May 28, 2025	1 yr 2 mo ago	FDA
8,617,550	Mar 03, 2026	5 mo ago	FDA
8,398,980	Feb 25, 2028	in 1 yr 8 mo	FDA
11,078,294	Jul 08, 2028	in 2 yr	FDA
8,574,869	Jul 08, 2028	in 2 yr	FDA
11,008,394	Dec 26, 2028	in 2 yr 6 mo	FDA
11,359,026	Dec 26, 2028	in 2 yr 6 mo	FDA
11,584,798	Dec 26, 2028	in 2 yr 6 mo	FDA
11,136,375	Jul 19, 2029	in 3 yr 1 mo	FDA
8,568,720	Nov 05, 2029	in 3 yr 4 mo	FDA
10,982,003	Aug 06, 2030	in 4 yr 1 mo	FDA
9,714,293	Aug 06, 2030	in 4 yr 1 mo	FDA
10,501,769	Oct 25, 2030	in 4 yr 4 mo	FDA
11,021,728	Oct 25, 2030	in 4 yr 4 mo	FDA
11,136,610	Oct 25, 2030	in 4 yr 4 mo	FDA
11,377,678	Oct 25, 2030	in 4 yr 4 mo	FDA
8,512,983	Jan 04, 2031	in 4 yr 6 mo	FDA
10,662,237	Aug 07, 2031	in 5 yr 2 mo	FDA
11,667,720	Nov 07, 2031	in 5 yr 5 mo	FDA
8,580,264	Nov 07, 2031	in 5 yr 5 mo	FDA
10,231,981	Dec 03, 2031	in 5 yr 5 mo	FDA
10,874,677	Mar 02, 2032	in 5 yr 8 mo	FDA
9,539,263	May 23, 2032	in 5 yr 11 mo	FDA
9,750,752	Aug 30, 2032	in 6 yr 3 mo	FDA
10,590,164	Mar 19, 2033	in 6 yr 9 mo	FDA
9,630,988	Jun 13, 2033	in 7 yr	FDA
10,676,710	Mar 14, 2034	in 7 yr 9 mo	FDA
10,829,732	Mar 14, 2034	in 7 yr 9 mo	FDA
10,017,732	Dec 25, 2034	in 8 yr 7 mo	FDA
10,336,983	Jul 31, 2035	in 9 yr 2 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 Tyenne's patents expire?

The FDA Purple Book lists 35 published patents for Tyenne, with the last listed patent expiring Jul 31, 2035. Every patent below links to its FDA source record so you can verify the expiration date.

Is Tyenne a biosimilar?

Yes. Tyenne is a Biosimilar 351(k) referencing tocilizumab, licensed under a 351(k) BLA.

Is Tyenne interchangeable?

Tyenne is a 351(k) biosimilar but does not carry an interchangeability designation in the Purple Book, so pharmacy-level substitution depends on state law.

What is Tyenne's BLA number?

Tyenne is licensed under BLA 761275, held by Fresenius Kabi USA, LLC.

When was Tyenne approved by the FDA?

Tyenne was approved by the FDA on Mar 05, 2024.

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