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Purple Book product · Reference 351(a)

Humira

adalimumab

351(a)BLA 125057RxLicensed AbbVie Inc.
View adalimumab family Label PDFOpen on FDA Purple Book

Nov 23, 2015

Approved

Reference 351(a)

License type

Rx

Marketing

66

Listed patents

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

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

Key dates

  1. Approval

    Approval date of this BLA submission.

    Nov 23, 2015

    10 yr 10 mo ago

  2. Today

  3. Orphan exclusivity ends

    7-year orphan-drug exclusivity window.

    Feb 24, 2028

    in 1 yr 8 mo

Pharmaceutical detail

Strength

40MG/0.4ML

Dosage form

Injection

Route

Subcutaneous

Presentation

Pre-Filled Syringe

Center

CDER

License number

1889

Product number

006

Submission type

Supplement

Supplement number

394

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. Its approved biosimilars and interchangeables are listed below.

10 additional BLA records for this product (other strengths or presentations) are in the same reference family.

Patent list (66)

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
PatentExpiresInSource
8,911,737Jun 05, 20224 yr 2 mo agoFDA
8,974,790Jun 05, 20224 yr 2 mo agoFDA
8,992,926Jun 05, 20224 yr 2 mo agoFDA
9,546,212Jun 05, 20224 yr 2 mo agoFDA
6,805,686May 06, 20233 yr 3 mo agoFDA
8,906,373Jul 18, 20233 yr 1 mo agoFDA
9,067,992Jul 18, 20233 yr 1 mo agoFDA
9,085,620Jul 18, 20233 yr 1 mo agoFDA
9,090,689Jul 18, 20233 yr 1 mo agoFDA
8,961,973Apr 11, 20251 yr 3 mo agoFDA
8,961,974Apr 11, 20251 yr 3 mo agoFDA
8,986,693Apr 11, 20251 yr 3 mo agoFDA
9,061,005Apr 11, 20251 yr 3 mo agoFDA
9,187,559Apr 11, 20251 yr 3 mo agoFDA
9,512,216Apr 11, 20251 yr 3 mo agoFDA
8,808,700May 16, 20262 mo agoFDA
11,083,792Apr 04, 2027in 9 moFDA
8,231,876Apr 04, 2027in 9 moFDA
8,883,156Apr 04, 2027in 9 moFDA
8,895,009Apr 04, 2027in 9 moFDA
8,906,372Apr 04, 2027in 9 moFDA
8,916,153Apr 04, 2027in 9 moFDA
9,096,666Apr 04, 2027in 9 moFDA
9,102,723Apr 04, 2027in 9 moFDA
9,273,132Apr 04, 2027in 9 moFDA
9,328,165Apr 04, 2027in 9 moFDA
9,913,902Apr 04, 2027in 9 moFDA
8,926,975Jun 08, 2027in 11 moFDA
8,715,664Jul 24, 2027in 1 yrFDA
8,663,945Sep 13, 2027in 1 yr 2 moFDA
8,906,646Sep 13, 2027in 1 yr 2 moFDA
8,911,964Sep 13, 2027in 1 yr 2 moFDA
9,090,867Sep 13, 2027in 1 yr 2 moFDA
9,234,032Sep 13, 2027in 1 yr 2 moFDA
9,284,371Sep 13, 2027in 1 yr 2 moFDA
8,889,136Oct 09, 2027in 1 yr 3 moFDA
9,284,370Jun 10, 2028in 1 yr 11 moFDA
9,669,093Jun 10, 2028in 1 yr 11 moFDA
11,167,030Nov 28, 2028in 2 yr 5 moFDA
11,191,834Nov 28, 2028in 2 yr 5 moFDA
9,085,619Nov 28, 2028in 2 yr 5 moFDA
8,420,081Jan 13, 2030in 3 yr 6 moFDA
8,999,337Feb 06, 2031in 4 yr 7 moFDA
9,624,295Mar 31, 2031in 4 yr 9 moFDA
8,708,968Jan 24, 2032in 5 yr 7 moFDA
9,339,610Jan 24, 2032in 5 yr 7 moFDA
9,062,106Apr 26, 2032in 5 yr 10 moFDA
9,090,688Apr 26, 2032in 5 yr 10 moFDA
9,505,834Apr 26, 2032in 5 yr 10 moFDA
9,522,953Apr 26, 2032in 5 yr 10 moFDA
9,683,033Apr 26, 2032in 5 yr 10 moFDA
9,957,318Apr 26, 2032in 5 yr 10 moFDA
9,085,618Mar 14, 2033in 6 yr 9 moFDA
9,181,337Mar 14, 2033in 6 yr 9 moFDA
9,181,572Mar 14, 2033in 6 yr 9 moFDA
9,290,568Mar 14, 2033in 6 yr 9 moFDA
9,334,319Mar 14, 2033in 6 yr 9 moFDA
9,346,879Mar 14, 2033in 6 yr 9 moFDA
9,359,434Mar 14, 2033in 6 yr 9 moFDA
9,499,616Mar 14, 2033in 6 yr 9 moFDA
9,708,400Mar 14, 2033in 6 yr 9 moFDA
9,315,574Apr 21, 2033in 6 yr 10 moFDA
9,150,645May 13, 2033in 6 yr 11 moFDA
9,266,949May 13, 2033in 6 yr 11 moFDA
9,499,614Mar 14, 2034in 7 yr 9 moFDA
9,550,826Nov 14, 2034in 8 yr 5 moFDA

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

  • v3Jul 02, 2026
  • v2Jul 02, 2026

Frequently asked questions

When do Humira's patents expire?

The FDA Purple Book lists 66 published patents for Humira, with the last listed patent expiring Nov 14, 2034. Every patent below links to its FDA source record so you can verify the expiration date.

Does Humira have approved biosimilars?

Yes. 3 approved follow-on biologics reference Humira in the Purple Book: Hyrimoz, Idacio, and Yuflyma.

What is Humira's BLA number?

Humira is licensed under BLA 125057, held by AbbVie Inc..

When was Humira approved by the FDA?

Humira was approved by the FDA on Nov 23, 2015.

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