What is Humira in the FDA Purple Book?

Humira, BLA 125057, is listed as a 351(a) reference biologic with 11 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 125057?

Humira, BLA 125057, lists AbbVie 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 Humira?

Humira, BLA 125057, has 11 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 Humira's reference-product relationship?

Humira, BLA 125057, is supported as a reference biologic by exact-BLA evidence and has 3 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 Humira interchangeable?

Humira, BLA 125057, 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 Humira licensed by FDA?

Humira, BLA 125057, has a listed FDA approval date of Nov 23, 2015. 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 Humira's FDA label?

Humira, BLA 125057, 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 Humira?

Humira, BLA 125057, has 66 published Purple Book patent rows, with the latest listed expiration on Nov 14, 2034. 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 Humira?

Humira, BLA 125057, has 1 populated Purple Book exclusivity field, with the latest listed date on Feb 24, 2028. Regulatory exclusivity dates are not patent opinions, inventory signals, or guaranteed market-entry dates.

FDA Purple Book product · 351(a) biologic

Humira

adalimumab

Humira, BLA 125057, is listed in the FDA Purple Book as a 351(a) reference biologic. This page consolidates 11 exact FDA presentation rows, and 3 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 125057 11 presentationsRxLicensed AbbVie Inc.

Approved

Nov 23, 2015

License type

351(a)

Marketing

Listed patents

Humira (adalimumab) is AbbVie Inc.'s FDA-licensed 351(a) biologic under BLA 125057, approved in 2015. The FDA Purple Book lists 66 published patents for it, the last expiring 2034. 3 distinct approved follow-on biologics explicitly reference Humira (Hyrimoz, Idacio, and Yuflyma), 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

125057

Regulatory role

351(a) reference biologic

Applicant

AbbVie Inc.

Applicant is not automatically the physical manufacturer.

Presentations

Exact FDA presentation rows under this BLA.

Approval

Nov 23, 2015

Follow-on biologics

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

3 distinct licensed follow-on biologics in the loaded Purple Book data name Humira 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.
Nov 23, 2015
11 yr ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Feb 24, 2028
in 1 yr 5 mo

Strengths & presentations

11 FDA presentation rows · BLA 125057

Strength

40MG/0.8ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Autoinjector

Center

CDER

License number

1889

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	40MG/0.8ML	Injection	Subcutaneous	Autoinjector	Licensed	Rx
002	40MG/0.8ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
003	20MG/0.4ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Disc*
004	40MG/0.8ML	Injection	Subcutaneous	Single-Dose Vial	Licensed	Disc*
005	10MG/0.2ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Disc*
006	40MG/0.4ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
007	40MG/0.4ML	Injection	Subcutaneous	Autoinjector	Licensed	Rx
008	80MG/0.8ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
009	80MG/0.8ML	Injection	Subcutaneous	Autoinjector	Licensed	Rx
010	20MG/0.2ML	Injection	Subcutaneous	Pre-Filled Syringe	Licensed	Rx
011	10MG/0.1ML	Injection	Subcutaneous	Pre-Filled Syringe	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 distinct 351(k) follow-on biologics are linked through FDA-stated reference names to Humira; 2 are designated interchangeable and 3 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
Humiraadalimumab	351(a) reference biologic	125057	Nov 23, 2015	40MG/0.4ML · Subcutaneous	Rx
Hyrimozadalimumab-adaz	351(k) interchangeable biosimilar	761071	Oct 30, 2018	40MG/0.8ML · Subcutaneous	Rx
Idacioadalimumab-aacf	351(k) biosimilar	761255	Dec 13, 2022	40MG/0.8ML · Subcutaneous	Rx
Yuflymaadalimumab-aaty	351(k) interchangeable biosimilar	761219	May 23, 2023	40MG/0.4ML · 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
8,911,737	Jun 05, 2022	4 yr 4 mo ago	FDA
8,974,790	Jun 05, 2022	4 yr 4 mo ago	FDA
8,992,926	Jun 05, 2022	4 yr 4 mo ago	FDA
9,546,212	Jun 05, 2022	4 yr 4 mo ago	FDA
6,805,686	May 06, 2023	3 yr 5 mo ago	FDA
8,906,373	Jul 18, 2023	3 yr 3 mo ago	FDA
9,067,992	Jul 18, 2023	3 yr 3 mo ago	FDA
9,085,620	Jul 18, 2023	3 yr 3 mo ago	FDA
9,090,689	Jul 18, 2023	3 yr 3 mo ago	FDA
8,961,973	Apr 11, 2025	1 yr 6 mo ago	FDA
8,961,974	Apr 11, 2025	1 yr 6 mo ago	FDA
8,986,693	Apr 11, 2025	1 yr 6 mo ago	FDA
9,061,005	Apr 11, 2025	1 yr 6 mo ago	FDA
9,187,559	Apr 11, 2025	1 yr 6 mo ago	FDA
9,512,216	Apr 11, 2025	1 yr 6 mo ago	FDA
8,808,700	May 16, 2026	4 mo ago	FDA
11,083,792	Apr 04, 2027	in 7 mo	FDA
8,231,876	Apr 04, 2027	in 7 mo	FDA
8,883,156	Apr 04, 2027	in 7 mo	FDA
8,895,009	Apr 04, 2027	in 7 mo	FDA
8,906,372	Apr 04, 2027	in 7 mo	FDA
8,916,153	Apr 04, 2027	in 7 mo	FDA
9,096,666	Apr 04, 2027	in 7 mo	FDA
9,102,723	Apr 04, 2027	in 7 mo	FDA
9,273,132	Apr 04, 2027	in 7 mo	FDA
9,328,165	Apr 04, 2027	in 7 mo	FDA
9,913,902	Apr 04, 2027	in 7 mo	FDA
8,926,975	Jun 08, 2027	in 9 mo	FDA
8,715,664	Jul 24, 2027	in 10 mo	FDA
8,663,945	Sep 13, 2027	in 1 yr	FDA
8,906,646	Sep 13, 2027	in 1 yr	FDA
8,911,964	Sep 13, 2027	in 1 yr	FDA
9,090,867	Sep 13, 2027	in 1 yr	FDA
9,234,032	Sep 13, 2027	in 1 yr	FDA
9,284,371	Sep 13, 2027	in 1 yr	FDA
8,889,136	Oct 09, 2027	in 1 yr 1 mo	FDA
9,284,370	Jun 10, 2028	in 1 yr 9 mo	FDA
9,669,093	Jun 10, 2028	in 1 yr 9 mo	FDA
11,167,030	Nov 28, 2028	in 2 yr 3 mo	FDA
11,191,834	Nov 28, 2028	in 2 yr 3 mo	FDA
9,085,619	Nov 28, 2028	in 2 yr 3 mo	FDA
8,420,081	Jan 13, 2030	in 3 yr 4 mo	FDA
8,999,337	Feb 06, 2031	in 4 yr 5 mo	FDA
9,624,295	Mar 31, 2031	in 4 yr 7 mo	FDA
8,708,968	Jan 24, 2032	in 5 yr 5 mo	FDA
9,339,610	Jan 24, 2032	in 5 yr 5 mo	FDA
9,062,106	Apr 26, 2032	in 5 yr 8 mo	FDA
9,090,688	Apr 26, 2032	in 5 yr 8 mo	FDA
9,505,834	Apr 26, 2032	in 5 yr 8 mo	FDA
9,522,953	Apr 26, 2032	in 5 yr 8 mo	FDA
9,683,033	Apr 26, 2032	in 5 yr 8 mo	FDA
9,957,318	Apr 26, 2032	in 5 yr 8 mo	FDA
9,085,618	Mar 14, 2033	in 6 yr 7 mo	FDA
9,181,337	Mar 14, 2033	in 6 yr 7 mo	FDA
9,181,572	Mar 14, 2033	in 6 yr 7 mo	FDA
9,290,568	Mar 14, 2033	in 6 yr 7 mo	FDA
9,334,319	Mar 14, 2033	in 6 yr 7 mo	FDA
9,346,879	Mar 14, 2033	in 6 yr 7 mo	FDA
9,359,434	Mar 14, 2033	in 6 yr 7 mo	FDA
9,499,616	Mar 14, 2033	in 6 yr 7 mo	FDA
9,708,400	Mar 14, 2033	in 6 yr 7 mo	FDA
9,315,574	Apr 21, 2033	in 6 yr 8 mo	FDA
9,150,645	May 13, 2033	in 6 yr 9 mo	FDA
9,266,949	May 13, 2033	in 6 yr 9 mo	FDA
9,499,614	Mar 14, 2034	in 7 yr 7 mo	FDA
9,550,826	Nov 14, 2034	in 8 yr 3 mo	FDA

Practical characteristics and limits

Source-bounded interpretation

Presentation coverage

11 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

AbbVie 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

Humira 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

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

Humira: 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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