HUMIRA Drug Profile

Summary for Tradename: HUMIRA

High Confidence Patents:	63
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for HUMIRA
Recent Clinical Trials:	See clinical trials for HUMIRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HUMIRA

See drug prices for HUMIRA

Recent Clinical Trials for HUMIRA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Teva takeda	Phase 4
Mabscale, LLC	Phase 3
Janssen Research & Development, LLC	Phase 1

See all HUMIRA clinical trials

Recent Litigation for HUMIRA

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
AbbVie Inc. v. Hetero USA, Inc.	2024-08-08
AbbVie Inc. v. Hetero USA, Inc.	2023-11-20
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29

See all HUMIRA litigation

PTAB Litigation

Petitioner	Date
Fresenius Kabi USA, LLC et al.	2019-09-17
	2017-12-20
Sandoz Inc.	2017-11-06

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

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. General 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 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	April 28, 2017		2027-09-13
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	February 21, 2008		2027-09-10
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	December 31, 2002		2033-03-14
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	April 21, 2017		2033-05-13
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	March 09, 2016		2028-10-06
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	April 24, 2013		2032-01-24

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

No patents found based on company disclosures

3) Low Certainty: US Patents for HUMIRA 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		2034-06-16	Patent claims search
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057		2032-12-21	Patent claims search
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057		2033-03-11	Patent claims search
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057		2033-03-13	Patent claims search
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057		2033-08-13	Patent claims search
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057		2039-02-26	Patent claims search

HUMIRA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for HUMIRA

Introduction

HUMIRA, developed by AbbVie, is a monoclonal antibody therapeutic that has been a cornerstone in the treatment of various autoimmune diseases, including rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. Despite its long-standing dominance, the market dynamics and financial trajectory of HUMIRA are undergoing significant changes due to several factors.

Market Size and Growth

The HUMIRA drug market has experienced strong growth in recent years. As of 2023, the market size was valued at $9.19 billion, and it is projected to grow to $9.86 billion in 2024, with a compound annual growth rate (CAGR) of 7.3%[1][3].

By 2028, the market is expected to reach $13.05 billion, driven by factors such as the entry of biosimilars, changes in healthcare policies, a focus on cost-effectiveness, increased investments in research and development, and the emphasis on precision medicine and personalized treatments[1][3].

Applications and End-Users

HUMIRA is used to treat a variety of autoimmune diseases, including ankylosing spondylitis, rheumatoid arthritis, Crohn’s disease, and other applications. The drug is administered through different forms, such as syringes and pens, and is used in various settings including hospitals, specialty clinics, and other healthcare facilities[1].

Regulatory Approvals

Broad regulatory approvals across multiple countries and regions have significantly contributed to the growth of the HUMIRA market. For instance, the U.S. Food and Drug Administration (FDA) approved an efficacy supplement for HUMIRA for the treatment of pediatric patients with moderately to severely active ulcerative colitis in February 2021. Additionally, the European Commission granted marketing authorization for a citrate-free high concentration formulation of the biosimilar Hyrimoz in April 2023[1].

Rise in Autoimmune Diseases

The increasing incidence rate of autoimmune diseases is a key driver for the demand of HUMIRA. According to Cleveland Clinics, 1 in 15 people in the U.S. suffer from an autoimmune disease, with one million individuals affected by lupus and 1.4 million suffering from Crohn’s disease or ulcerative colitis[1][3].

Impact of Biosimilars

The entry of biosimilars into the market has significantly impacted HUMIRA’s market share. Since the first biosimilars entered the U.S. market in January 2023, HUMIRA’s global sales have declined. By May 2024, HUMIRA’s market share had dropped to 82%, with biosimilars gaining ground, particularly Sandoz’s and Cordavis’s Hyrimoz, which now controls 13% of the market[4].

Pricing and Access

While pricing has not been a strong factor in eroding HUMIRA’s dominance, coverage and access have played crucial roles. The removal of HUMIRA from major national commercial formularies by CVS Caremark in April 2024 led to a significant increase in new prescriptions for biosimilars like Hyrimoz[4].

Financial Performance

AbbVie’s financial results reflect the impact of biosimilar competition on HUMIRA. In the second quarter of 2024, global HUMIRA net revenues decreased by 29.8% on a reported basis and 28.9% on an operational basis, reaching $2.814 billion. This decline is part of a broader trend; in 2023, HUMIRA’s global sales dipped by 32% to $14.4 billion due to growing biosimilar erosion[2][5].

Trends and Future Outlook

Several trends are expected to shape the future of the HUMIRA market:

Real-World Evidence Generation

The generation of real-world evidence will play a crucial role in demonstrating the efficacy and safety of HUMIRA and its biosimilars in real-world settings.

Expanded Use in Pediatric Populations

The approval of HUMIRA for pediatric patients with certain conditions is expected to expand its user base.

Shift Towards Self-Administered Medications

There is a growing trend towards self-administered medications, which could impact the way HUMIRA is prescribed and used.

Value-Based Pricing Models

The adoption of value-based pricing models is likely to influence the pricing strategy for HUMIRA and its biosimilars.

Targeted Therapies Development

The development of targeted therapies will continue to be a focus, potentially offering more precise treatment options for autoimmune diseases[1][3].

Key Takeaways

• The HUMIRA market is expected to grow to $13.05 billion by 2028, driven by biosimilar market entry, healthcare policy changes, and a focus on cost-effectiveness.
• The rise in autoimmune diseases is a significant driver for HUMIRA demand.
• Regulatory approvals across multiple regions have expanded HUMIRA’s accessibility.
• Biosimilars have eroded HUMIRA’s market share, particularly due to changes in formulary coverage.
• AbbVie’s financial performance reflects the decline in HUMIRA sales due to biosimilar competition.
• Future trends include real-world evidence generation, expanded pediatric use, a shift towards self-administered medications, and the adoption of value-based pricing models.

FAQs

Q: What is the current market size of HUMIRA?

The HUMIRA drug market size was valued at $9.19 billion in 2023 and is projected to grow to $9.86 billion in 2024[1][3].

Q: How has the entry of biosimilars affected HUMIRA’s market share?

The entry of biosimilars has led to a decline in HUMIRA’s market share, with its share dropping to 82% by May 2024, while biosimilars have gained around 18% of the market[4].

Q: What are the key drivers for the growth of the HUMIRA market?

Key drivers include the rise in autoimmune diseases, broad regulatory approvals, and trends such as real-world evidence generation and the shift towards self-administered medications[1][3].

Q: How have regulatory approvals impacted the HUMIRA market?

Regulatory approvals across multiple countries and regions have significantly expanded the accessibility of HUMIRA, contributing to its growth[1].

Q: What is the financial impact of biosimilar competition on AbbVie’s HUMIRA sales?

AbbVie’s HUMIRA sales have declined significantly due to biosimilar competition, with global sales dipping by 32% to $14.4 billion in 2023[2][5].

Sources

1. The Business Research Company, "Humira Drug Global Market Report 2024, Industry Size, 2033"
2. PR Newswire, "AbbVie Reports Second-Quarter 2024 Financial Results"
3. Research and Markets, "Humira Drug Global Market Report 2024"
4. BioSpace, "AbbVie's Humira Continues to Lose Market Share as Biosimilars Gain Ground"
5. AbbVie Investors, "AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results"