SIMPONI ARIA Drug Profile

Summary for Tradename: SIMPONI ARIA

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for SIMPONI ARIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SIMPONI ARIA

Recent Clinical Trials for SIMPONI ARIA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Pennsylvania	Phase 3
Janssen Scientific Affairs, LLC	Phase 3
The First Hospital of Jilin University	Phase 1

See all SIMPONI ARIA clinical trials

Recent Litigation for SIMPONI ARIA

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
AMGEN INC. v. APOTEX INC.	2022-06-14

See all SIMPONI ARIA litigation

PTAB Litigation

Petitioner	Date
	2017-12-20

See all SIMPONI ARIA litigation

Pharmacology for SIMPONI ARIA

Mechanism of Action	Tumor Necrosis Factor Receptor Blocking Activity
Established Pharmacologic Class	Tumor Necrosis Factor Blocker

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 SIMPONI ARIA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Janssen Biotech, Inc.	SIMPONI ARIA	golimumab	Injection	125433	11,014,982		Company disclosures
Janssen Biotech, Inc.	SIMPONI ARIA	golimumab	Injection	125433	11,041,020	2039-07-20	Company disclosures

3) Low Certainty: US Patents for SIMPONI ARIA 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
Janssen Biotech, Inc.	SIMPONI ARIA	golimumab	Injection	125433	10,010,585	2034-06-16	Patent claims search
Janssen Biotech, Inc.	SIMPONI ARIA	golimumab	Injection	125433	10,012,654	2032-12-21	Patent claims search
Janssen Biotech, Inc.	SIMPONI ARIA	golimumab	Injection	125433	10,016,338	2033-03-11	Patent claims search
Janssen Biotech, Inc.	SIMPONI ARIA	golimumab	Injection	125433	10,028,940	2033-08-13	Patent claims search

SIMPONI ARIA Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for SIMPONI ARIA

Introduction

SIMPONI ARIA, a fully human anti-TNF-alpha monoclonal antibody, has been a significant player in the treatment of autoimmune diseases, particularly rheumatoid arthritis. Developed by Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, this drug has shown promising results in clinical trials and has a substantial market presence.

Clinical Efficacy and Approval

SIMPONI ARIA has demonstrated strong clinical efficacy in treating adults with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate. Clinical trials have shown that nearly 70% of patients receiving SIMPONI ARIA achieved at least a 20% improvement in the American College of Rheumatology (ACR 20) score at week 100[1].

Mechanism of Action

SIMPONI ARIA works by targeting both soluble and transmembrane bioactive forms of TNF-alpha, a protein that causes inflammation and damage to bones, cartilage, and tissue in chronic inflammatory diseases. By binding with and blocking TNF-alpha, SIMPONI ARIA helps control inflammation and inhibit the progression of further joint damage[1].

Market Size and Forecast

The market for Golimumab, the active ingredient in SIMPONI ARIA, was valued at USD 20.1 billion in 2023 and is projected to reach USD 39.3 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% during the forecast period 2024-2031[3].

Key Market Drivers

Several factors drive the growth of the SIMPONI ARIA market:

• Aging Population: An increase in the aging population, who are at higher risk for developing autoimmune diseases, drives market growth.
• High Unmet Medical Need: Despite available treatments, there remains a segment of patients who do not respond well to conventional therapies, creating a strong demand for biologics like SIMPONI ARIA.
• Healthcare Infrastructure Improvements: Enhanced healthcare access in developing regions leads to increased diagnosis and treatment of autoimmune disorders.
• Strategic Partnerships and Collaborations: Pharmaceutical companies engage in partnerships to enhance drug development and marketing capabilities.
• Insurance Coverage and Reimbursement: Favorable reimbursement policies and insurance coverage improve access for patients[3].

Geographical Segmentation

The market for SIMPONI ARIA is segmented geographically:

• North America: High market penetration due to advanced healthcare infrastructure and strong reimbursement policies.
• Europe: Diverse healthcare systems with varying levels of access to medications across countries.
• Asia-Pacific: Rapid economic development and improving healthcare facilities, particularly in densely populated countries like China and India.
• Middle East and Africa: Growing awareness of biologics and increased healthcare expenditure, though market penetration remains low due to sporadic access to healthcare resources[3].

Financial Performance

In 2022, the combined net revenues worldwide from sales of SIMPONI and SIMPONI ARIA were nearly U.S. $2.3 billion[4]. Johnson & Johnson's pharmaceutical segment, which includes SIMPONI ARIA, has shown consistent growth. For example, in Q3 2024, Johnson & Johnson reported a 5.2% increase in sales to $22.5 billion, with operational growth of 6.3% and adjusted operational growth of 5.4%[2].

Competitive Landscape

The market for SIMPONI ARIA faces competition from several major players:

• Johnson & Johnson: The primary developer and marketer of SIMPONI ARIA.
• Merck & Co., Inc.
• AbbVie Inc.
• Pfizer Inc.
• Amgen Inc.
• Bristol-Myers Squibb Company
• Eli Lilly and Company
• Roche Holding AG
• Novartis AG
• **Sanofi S.A.[3].

Challenges and Limitations

Despite its strong market position, the SIMPONI ARIA market faces several challenges:

• High Cost of Treatment: The cost associated with SIMPONI ARIA therapy can be prohibitively high for some patients and healthcare systems.
• Stringent Regulatory Requirements: The approval process for biologic drugs is rigorous and can lead to delays.
• Competition from Biosimilars: As patents expire, the entry of biosimilars can significantly impact the market share of SIMPONI ARIA.
• Safety and Side Effects: Concerns regarding the safety profile and potential side effects, including risks of infections and malignancies, can limit its use[3].

Future Outlook

The future outlook for SIMPONI ARIA is promising, driven by increasing demand for biologic therapies and improvements in healthcare infrastructure. However, the market will need to navigate the challenges posed by biosimilars and stringent regulatory requirements.

Key Takeaways

• Clinical Efficacy: SIMPONI ARIA has shown strong clinical efficacy in treating rheumatoid arthritis.
• Market Growth: The market is projected to grow at a CAGR of 5% from 2024 to 2031.
• Geographical Segmentation: North America and Europe are key markets, with growing potential in the Asia-Pacific region.
• Financial Performance: Combined net revenues from SIMPONI and SIMPONI ARIA were nearly U.S. $2.3 billion in 2022.
• Competitive Landscape: The market is competitive with several major pharmaceutical companies involved.
• Challenges: High cost, stringent regulatory requirements, and competition from biosimilars are significant challenges.

FAQs

Q: What is SIMPONI ARIA used for? A: SIMPONI ARIA is used for the treatment of adults with moderately to severely active rheumatoid arthritis in combination with methotrexate.

Q: How does SIMPONI ARIA work? A: SIMPONI ARIA works by targeting and blocking TNF-alpha, a protein that causes inflammation and damage in chronic inflammatory diseases.

Q: What are the key drivers of the SIMPONI ARIA market? A: Key drivers include an aging population, high unmet medical need, improvements in healthcare infrastructure, strategic partnerships, and favorable insurance coverage.

Q: What are the main geographical markets for SIMPONI ARIA? A: The main markets are North America, Europe, and the Asia-Pacific region, with growing potential in the Middle East and Africa.

Q: What challenges does the SIMPONI ARIA market face? A: The market faces challenges such as high treatment costs, stringent regulatory requirements, competition from biosimilars, and concerns over safety and side effects.

Sources

1. Janssen Research & Development, LLC. "New Two-Year Results Show SIMPONI® ARIA™ (GOLIMUMAB) For Infusion Inhibited Radiographic Progression In Patients With Active Rheumatoid Arthritis." October 28, 2013.
2. Johnson & Johnson. "Johnson & Johnson Reports Q3 2024 Results." October 15, 2024.
3. Verified Market Research. "Golimumab (Simponi) Market Size, Share, Scope and Trends."
4. Alvotech. "Alvotech Reports Financial Results for First three Months of 2023." May 19, 2023.