Adalimumab - Biologic Drug Details

Summary for adalimumab

Tradenames:	1
High Confidence Patents:	63
Applicants:	11
BLAs:	11
Suppliers: see list	17
Recent Clinical Trials:	See clinical trials for adalimumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for adalimumab

Recent Clinical Trials for adalimumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Assistance Publique - Hpitaux de Paris	PHASE2
University Medical Center Groningen	PHASE1
University of California, San Francisco	PHASE4

See all adalimumab clinical trials

Recent Litigation for adalimumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
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 adalimumab litigation

PTAB Litigation

Petitioner	Date
	2017-12-20
Sandoz Inc.	2017-11-06
Sandoz Inc.	2017-10-02

See all adalimumab 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

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.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching 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.

3. Patents from broad patent text search

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 adalimumab 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	April 28, 2017	9,234,032	2027-09-13
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	March 09, 2016	8,708,968	2032-01-24
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	October 17, 2016	8,906,373	2023-07-18
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	April 21, 2017	8,961,974	2025-11-04

2) High Certainty: US Patents for adalimumab 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

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	10,010,585	2035-06-16	Patent claims search
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	10,012,654	2033-12-23	Patent claims search
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	10,016,338	2036-12-20	Patent claims search
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	10,023,608	2034-03-13	Patent claims search

International Patents for adalimumab

Country	Patent Number	Estimated Expiration
South Korea	20150043568
Denmark	1406656
Taiwan	201000131
China	105412922

Supplementary Protection Certificates for adalimumab

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

Market Dynamics and Financial Trajectory for Adalimumab

Last updated: February 19, 2026

Adalimumab, marketed as Humira by AbbVie, is a monoclonal antibody used primarily to treat autoimmune conditions such as rheumatoid arthritis, Crohn’s disease, and psoriasis. It remains the top-selling biologic globally but faces intensifying competition, patent expirations, and manufacturing challenges impacting its market performance.

Market Size and Growth

The global biologics market was valued at approximately $383 billion in 2021. Adalimumab accounted for about 23% of this market, with global sales reaching nearly $21 billion in 2022.

Year	Global Adalimumab Sales (USD billions)	Growth %	Market Share (%)
2019	18.6	8.0	21%
2020	20.2	8.6	21.5%
2021	21.2	4.9	22%
2022	21.8	2.8	22.5%

The growth has slowed since 2021, with revenues plateauing due to several patent expirations.

Patent Landscape and Competition

AbbVie's patent protections began to expire in the U.S. and Europe starting in 2018. Key biosimilar entrants include:

• Amgen’s Amjevita (2017 in U.S. approval, launched in 2019)
• Samsung Bioepis' Hadlima (2022 approval)
• Sandoz’s Hyrimoz (approved in 2018)

Biosimilar competition has led to price reductions of approximately 30% in the U.S. and Europe since 2019. The inflow of biosimilars has accelerated market share erosion for Humira.

Pricing Dynamics

Original branded Humira’s list price in the U.S. was approximately $5,500 per 40 mg pen in 2018. Post-patent expirations, biosimilar list prices are around 30-35% lower, translating to reduced patient out-of-pocket costs and heightened payer negotiations.

Year	Average List Price (USD) for Humira	Price Reduction from 2018 (%)
2018	5,500	0%
2020	4,650	15.5%
2022	4,100	25%

Revenue Projections and Outlook

AbbVie’s revenue from Humira peaked at approximately $20 billion in 2018. Post-patent loss, revenue declined to about $16 billion in 2021 and is projected to fall further to $10-12 billion by 2025, driven by biosimilar penetration.

Year	Projected Revenue (USD billions)	Key Drivers
2023	13.8	Ongoing biosimilar entry
2024	11.5	Market share erosion continues
2025	10-12	Biosimilar dominance

In response, AbbVie and competitors are pursuing new indications, formulation innovations, and combination therapies to sustain revenues.

Regulatory and Policy Environment

Biosimilar approvals in major markets facilitate market entry:

• US: FDA approved several biosimilars, including Amjevita (2017) and Hyrimoz (2018).
• EU: EMA approved biosimilars from 2018 onwards.
• Pricing policies and patent litigations influence biosimilar market share expansion.

R&D and Market Expansion

AbbVie invests heavily in developing next-generation biologics and biosimilars. Its pipeline includes biosimilars for Stelara and other immunomodulators, aiming to diversify revenue sources.

Key Takeaways

• Adalimumab remains a top-selling biologic, but revenues face decline due to biosimilar erosion.
• Patent expirations and biosimilar approvals have driven pricing down 30-35% since 2018.
• Revenue projections suggest a decline from $20 billion in 2018 to approximately $10-12 billion by 2025.
• Market competitiveness will intensify with new biosimilar entrants and regulatory policies.
• R&D efforts pivot towards newer indications, formulations, and biosimilar portfolios to offset market share losses.

FAQs

1. How significant are biosimilar impacts on adalimumab revenues?
Biosimilar entry has reduced Humira’s list prices by approximately 30-35%, causing an estimated revenue decline of $8 billion between 2018 and 2022.

2. When will the U.S. market see the full impact of biosimilar competition?
Full impact is expected through 2024-2025, as biosimilars gain market share, supported by payer negotiations and patent litigations.

3. What strategies are pharmaceutical companies implementing to maintain revenue?
Developing new indications, introducing innovative formulations, and expanding biosimilar portfolios are primary strategies.

4. How has pricing trended post-patent expiration?
Prices have decreased significantly across markets, with U.S. list prices dropping roughly 25% since 2018.

5. What are the main regulatory challenges facing biosimilar entry?
Patent litigations and regulatory pathways influence biosimilar approval timing, impacting market penetration.

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References

[1] Markets and Markets. (2022). Biologics market size, share & trends analysis.
[2] FDA. (2022). Approved biosimilars.
[3] AbbVie. (2022). Humira revenue report.
[4] IQVIA. (2022). Biologic drugs and biosimilar market analysis.
[5] European Medicines Agency. (2022). Biosimilar approvals.