What is Actemra in the FDA Purple Book?

Actemra, BLA 125472, is listed as a 351(a) 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 125472?

Actemra, BLA 125472, lists Genentech, 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 Actemra?

Actemra, BLA 125472, 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 Actemra's reference-product relationship?

Actemra, BLA 125472, does not state a reference product in the loaded FDA row. That bounded result is not proof about future eligibility or relationships outside this snapshot. This answer is limited to the current FDA Purple Book record and its exact BLA-level fields.

Is Actemra interchangeable?

Actemra, BLA 125472, 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 Actemra licensed by FDA?

Actemra, BLA 125472, has a listed FDA approval date of Nov 19, 2018. 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 Actemra's FDA label?

Actemra, BLA 125472, 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 Actemra?

Actemra, BLA 125472, 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 Actemra?

Actemra, BLA 125472, has 1 populated Purple Book exclusivity field, with the latest listed date on Sep 04, 2028. Regulatory exclusivity dates are not patent opinions, inventory signals, or guaranteed market-entry dates.

FDA Purple Book product · 351(a) biologic

Actemra

tocilizumab

Actemra, BLA 125472, is listed in the FDA Purple Book as a 351(a) biologic. This page consolidates 2 exact FDA presentation rows, and no exact reference-product relationship is asserted. 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 125472 2 presentationsRxLicensed Genentech, Inc.

Approved

Nov 19, 2018

License type

351(a)

Marketing

Listed patents

Actemra (tocilizumab) is Genentech, Inc.'s FDA-licensed 351(a) biologic under BLA 125472, approved in 2018. The FDA Purple Book lists 35 published patents for it, the last expiring 2035. 3 351(k) products in the loaded data name-link to Actemra, but the available fields do not unambiguously assign that relationship to this exact BLA; the page therefore does not call it a proven reference BLA.

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

What this Purple Book record establishes

Regulatory interpretation

BLA number

125472

Regulatory role

351(a) biologic

Applicant

Genentech, Inc.

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Nov 19, 2018

Reference product

Not stated

Actemra is an FDA-licensed 351(a) biologic.

FDA rows name-link 3 351(k) products to Actemra, but the loaded data does not unambiguously assign that relationship to BLA 125472.

Substitution boundary

The absence of a linked 351(k) record is a bounded database result, not proof that the product can never serve as a reference product.

Key dates

Licensure & exclusivity

Approval
Approval date of this BLA submission.
Nov 19, 2018
7 yr 11 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Sep 04, 2028
in 2 yr

Strengths & presentations

2 FDA presentation rows · BLA 125472

Strength

162MG/0.9ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Pre-Filled Syringe

Center

CDER

License number

1048

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

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

3 follow-on products are linked to the same FDA-stated reference name, but this exact BLA's reference-product role remains unresolved.

No reference product is stated in this exact Purple Book row. This is a bounded snapshot result, not proof of real-world absence.

Reference-family comparison

Purple Book comparison of products in this reference family
Product	Designation	BLA	Approved	Presentation	Marketing
Actemratocilizumab	351(a) biologic	125472	Nov 19, 2018	162MG/0.9ML · Subcutaneous	Rx
Tofidencetocilizumab-bavi	351(k) biosimilar	761354	Sep 29, 2023	80MG/4ML (20MG/ML) · Intravenous	Rx
Tyennetocilizumab-aazg	351(k) biosimilar	761275	Mar 05, 2024	80MG/4ML (20MG/ML) · Intravenous	Rx
Avtozmatocilizumab-anoh	351(k) interchangeable biosimilar	761498	Jan 24, 2025	162MG/0.9ML · Subcutaneous	Rx

This brand is also licensed under 1 other BLA:

BLA 12527680MG/4ML (20MG/ML)

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	6 mo ago	FDA
8,398,980	Feb 25, 2028	in 1 yr 6 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 11 mo	FDA
8,568,720	Nov 05, 2029	in 3 yr 2 mo	FDA
10,982,003	Aug 06, 2030	in 4 yr	FDA
9,714,293	Aug 06, 2030	in 4 yr	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 5 mo	FDA
10,662,237	Aug 07, 2031	in 5 yr	FDA
11,667,720	Nov 07, 2031	in 5 yr 3 mo	FDA
8,580,264	Nov 07, 2031	in 5 yr 3 mo	FDA
10,231,981	Dec 03, 2031	in 5 yr 4 mo	FDA
10,874,677	Mar 02, 2032	in 5 yr 7 mo	FDA
9,539,263	May 23, 2032	in 5 yr 9 mo	FDA
9,750,752	Aug 30, 2032	in 6 yr 1 mo	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

Genentech, 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

Actemra is an FDA-licensed 351(a) biologic. 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

Actemra: 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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