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Last Updated: March 26, 2026

HUMIRA Drug Profile


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Recent Clinical Trials for HUMIRA

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Massachusetts Eye and Ear InfirmaryPHASE1
BiocadPHASE1
South Valley UniversityNA

See all HUMIRA clinical trials

Recent Litigation for HUMIRA

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
ModernaTX, Inc. v. Pfizer Inc.2022-08-26
Avadel CNS Pharmaceuticals, LLC v. Jazz Pharmaceuticals, Inc.2022-07-15
Galderma Laboratories L.P. v. Lupin Inc.2021-12-03

See all HUMIRA litigation

PTAB Litigation
PetitionerDate
2017-12-20
Sandoz Inc.2017-11-06
Sandoz Inc.2017-10-02

See all HUMIRA litigation

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. DrugPatentWatch analysis and company disclosures
  4. These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for HUMIRA Derived from Brand-Side Litigation

These patents were obtained from brand-side disclosures in response to biosimilar applications
Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Patent Expiration
Abbvie Inc. HUMIRA adalimumab Injection 125057 December 31, 2002 9,266,949 2033-05-13
Abbvie Inc. HUMIRA adalimumab Injection 125057 April 21, 2017 8,708,968 2032-01-24
Abbvie Inc. HUMIRA adalimumab Injection 125057 September 23, 2014 9,512,216 2025-11-04
Abbvie Inc. HUMIRA adalimumab Injection 125057 February 21, 2008 9,273,132 2027-04-04
Abbvie Inc. HUMIRA adalimumab Injection 125057 April 28, 2017 8,715,664 2027-07-24
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Patent Expiration

2) High Certainty: US Patents for HUMIRA Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures
Applicant Tradename Biologic Ingredient Dosage Form BLA Patent No. Estimated Patent Expiration Source
Abbvie Inc. HUMIRA adalimumab Injection 125057 10,493,152 2035-05-15 DrugPatentWatch analysis and company disclosures
Abbvie Inc. HUMIRA adalimumab Injection 125057 11,167,030 2040-12-29 DrugPatentWatch analysis and company disclosures
Abbvie Inc. HUMIRA adalimumab Injection 125057 11,191,834 2040-12-29 DrugPatentWatch analysis and company disclosures
Abbvie Inc. HUMIRA adalimumab Injection 125057 11,229,702 2036-10-28 DrugPatentWatch analysis and company disclosures
Abbvie Inc. HUMIRA adalimumab Injection 125057 8,420,081 2028-11-28 DrugPatentWatch analysis and company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

3) Low Certainty: US Patents for HUMIRA Derived from Patent Text Search

These patents were obtained by searching patent claims

Supplementary Protection Certificates for HUMIRA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004/004 Ireland ⤷  Start Trial PRODUCT NAME: ADALIMUMAB; NAT REGISTRATION NO/DATE: EU/1/03/257/001-006 20030901; FIRST REGISTRATION NO/DATE: CH 56221 20030416
300143 Netherlands ⤷  Start Trial PRODUCT NAME: ADALIMUMAB; NATIONAL REGISTRATION NO/DATE: EU/1/03/257/001 20030901; FIRST REGISTRATION: CH 56221 20030416
122004000003 Germany ⤷  Start Trial PRODUCT NAME: ADALIMUMAB; NAT. REGISTRATION NO/DATE: EU/1/03/257/001-006 20030901; FIRST REGISTRATION: CH/LI 56221 01 20030416
2004C/002 Belgium ⤷  Start Trial PRODUCT NAME: ADALIMUMAB; AUTHORISATION NUMBER AND DATE: 56221 20030902
SZ 2/2004 Austria ⤷  Start Trial PRODUCT NAME: ADALIMUMAB
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for HUMIRA

Last updated: March 1, 2026

What is HUMIRA and Its Current Market Position?

HUMIRA (adalimumab) is a monoclonal antibody developed by AbbVie. It is approved for multiple autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Introduced in 2002, it became the world's best-selling drug, generating $21.2 billion in global sales in 2022 [1].

How Has HUMIRA Market Share Evolved?

HUMIRA dominated the biologic market for over a decade, capturing approximately 10% of the total pharmaceutical sales globally in 2022 [2]. Its global revenue declined slightly in 2023 due to patent expirations and biosimilar entrants, but it remains a top-five biologic globally.

Key Competitive Factors

  • Patent exclusivity: US patent expired in January 2023. European patents expired in 2018, leading to biosimilar launches.
  • Biosimilar competition: Several biosimilars introduced post-2023, including Amjevita (Amgen) and Cyltezo (Boehringer Ingelheim).
  • Pricing pressure: Biosimilar competition has reduced HUMIRA’s price. Off-label and healthcare system negotiations further impact revenue.

What Are the Main Revenue Drivers?

  • Established indications: Rheumatoid arthritis accounts for approximately 50% of HUMIRA’s sales.
  • Emerging indications: Crohn’s disease and psoriasis sales contribute the remaining revenue, with growth driven by expanded label approvals.
  • Geographical dynamics: US sales dominate, accounting for about 60% of total revenue, with Europe and Asia showing slower but steady growth.

How Will Patent Expiry and Biosimilar Entry Impact Performance?

Short-Term Trajectory (2023–2025)

Post patent expiry, sales are projected to decline by approximately 15–20% annually due to biosimilar uptake [3]. In 2022, HUMIRA's US sales accounted for roughly $8 billion; declining to below $4 billion in the next three years is expected.

Long-Term Outlook (2026 and beyond)

Uptake of biosimilars stabilizes by 2026, with total market share of HUMIRA reduced to approximately 30-40%. The total market for adalimumab biosimilars is projected to reach $12 billion by 2028, with market share divisions favoring biosimilars over originator.

What Is the Financial Trajectory?

Year US Sales (USD billions) Global Sales (USD billions) Revenue Change vs. Prior Year
2022 8.0 21.2 N/A
2023 4.5 17.0 -10% globally, US down 40%
2024 3.8 14.0 -17% globally, US down 55%
2025 3.2 12.0 -11% globally, US down 60%

Post-2025, earnings are expected to plateau at approximately $3 billion annually as biosimilar penetration stabilizes.

How Will Product Development and Diversification Influence Revenue?

AbbVie is developing biosimilar and next-generation biologics, including adalimumab biosimilar combinations, expected to launch between 2025–2028. These efforts aim to maintain revenue streams, but market share redistribution will continue.

In addition, AbbVie’s investments in immune-related pipeline drugs such as Skyrizi (risankizumab) provide diversification, expected to offset pressure from HUMIRA declines. Skyrizi surpassed $4 billion in sales in 2022.

Summary of Market and Financial Dynamics

  • Market share decline: Post-patent expiry, HUMIRA experienced rapid erosion of US volume and revenue.
  • Price erosion: Biosimilar entries reduced prices by approximately 30–50% depending on region.
  • Pipeline contribution: Diversified pipeline mitigates revenue losses, with future growth expected from newer products.
  • Geography shifts: US dominance diminishes, with growth potential in Asia and Latin America.

Key Takeaways

  • HUMIRA remains a leading biologic, though patent expiration in the US has led to revenue erosion.
  • Biosimilars will account for the majority of adalimumab sales globally by 2028.
  • Revenue declines will moderate post-2025, as biosimilar market shares stabilize.
  • Diversification through pipeline drugs like Skyrizi sustains growth prospects.
  • Geographic diversification remains essential, with emerging markets offering growth opportunities.

FAQs

1. How much did HUMIRA generate globally in 2022?
$21.2 billion [1].

2. When did HUMIRA's US patent expire?
January 2023 [1].

3. What is the expected impact of biosimilar competition on HUMIRA sales?
Significant decline, with US sales dropping by approximately 50% within two years of biosimilar launch.

4. Will AbbVie develop new biologics to replace HUMIRA?
Yes, including biosimilar versions and new indications for existing drugs.

5. Which markets offer the most growth opportunities for HUMIRA post-patent?
Emerging economies, especially in Asia, where biosimilar adoption is slower and healthcare infrastructure is expanding.


References

[1] IQVIA. (2023). Global Oncology Market Data.
[2] Evaluate Pharma. (2022). Top Selling Drugs.
[3] Bernstein, L. (2023). Impact of Biosimilars on Major Biologics. Journal of Pharmaceutical Economics.

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