EYLEA Drug Profile

Summary for Tradename: EYLEA

High Confidence Patents:	56
Applicants:	1
BLAs:	2

Pharmacology for EYLEA

Mechanism of Action	Vascular Endothelial Growth Factor Inhibitors
Established Pharmacologic Class	Vascular Endothelial Growth Factor Inhibitor

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 company disclosures

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.

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 EYLEA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for EYLEA 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
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2037-03-28	DrugPatentWatch analysis and company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2036-03-10	DrugPatentWatch analysis and company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2038-10-12	DrugPatentWatch analysis and company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2038-10-12	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for EYLEA 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
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2037-12-21	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2035-11-23	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2036-11-15	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2035-03-17	Patent claims search

International Patents for EYLEA

Country	Patent Number	Estimated Expiration
Colombia	2020014427
Malaysia	190623
Taiwan	202041672
Singapore	10202111177V

Supplementary Protection Certificates for EYLEA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C201300026	Spain		PRODUCT NAME: AFLIBERCEPT; NATIONAL AUTHORISATION NUMBER: EU/1/12/797/001-002; DATE OF AUTHORISATION: 20121122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/797/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20121122
2013/016	Ireland		PRODUCT NAME: AFLIBERCEPT; REGISTRATION NO/DATE: EU/1/12/797/001-002 20121122
PA2013009	Lithuania		PRODUCT NAME: AFLIBERCEPTUM; REGISTRATION NO/DATE: EU/1/12/797/001, 2012 11 22 EU/1/12/797/002, 2012 11 22 EU/1/12/814 20130201
92195	Luxembourg		PRODUCT NAME: AFLIBERCEPT (EYLEA - ZALTRAP)

Market Dynamics and Financial Trajectory for the Biologic Drug: EYLEA

Last updated: November 12, 2025

Introduction

EYLEA (aflibercept), a flagship anti-VEGF biologic developed by Regeneron Pharmaceuticals, has revolutionized the treatment landscape for neovascular age-related macular degeneration (AMD) and other ocular vascular diseases. Since its market introduction in 2011, EYLEA has established a dominant presence in the ophthalmology space, catalyzed by its efficacy profile and extended dosing intervals. Understanding the evolving market dynamics and financial trajectory for EYLEA involves analyzing competitive positioning, demand drivers, patent landscape, regulatory status, and potential future growth avenues.

Market Overview and Key Players

The global ophthalmology biologics market, primarily driven by anti-VEGF therapies, is projected to grow at a compound annual growth rate (CAGR) exceeding 6% over the next five years, reaching valued estimates of over $7 billion by 2027 [1]. EYLEA's primary competitors include Roche’s ranibizumab (Lucentis) and Novartis/Astellas’ brolucizumab (Beovu), alongside emerging biosimilars and newer agents.

EYLEA’s broader indication portfolio extends beyond AMD to diabetic macular edema (DME), central retinal vein occlusion (CRVO), and myopic choroidal neovascularization, further cementing its market scope. The drug’s flexible dosing schedule—monthly initial injections, transitioned to bimonthly or quarterly regimens—has translated into improved patient compliance and healthcare outcomes, reinforcing its competitive advantage.

Market Dynamics Influencing EYLEA

Demand Drivers

• Aging Population: The global increase in elderly populations accelerates the incidence of AMD and other vascular retinal diseases, significantly driving demand for effective treatments like EYLEA [2].
• Growing Disease Burden: Rising prevalence of diabetes exacerbates demand for DME therapies, with EYLEA positioned as a prominent treatment option due to its proven efficacy.
• Treatment Paradigm Shifts: The transition toward less frequent dosing regimens and longer-acting biologics tends to favor EYLEA, given its established extended dosing intervals and safety profile.

Competitive Landscape

• Innovation and Biosimilars: The entry of biosimilars for ranibizumab and escalating competition from next-generation agents like brolucizumab challenge EYLEA's market share. However, patent protections and data exclusivity provisions are prolonging EYLEA’s market dominance.
• Regulatory Approvals: Ongoing approvals in emerging markets and new indications facilitate EYLEA's geographical and therapeutic expansion.

Regulatory and Patent Challenges

• Patent Expiry and Biosimilar Entry: Regeneron’s primary patents on EYLEA are set to expire in the U.S. around 2023-2024, risking biosimilar competition. However, patent litigation and data exclusivity extensions may delay biosimilar entry, providing a temporary competitive respite.
• Global Patent Strategies: Strategically, Regeneron and Bayer (partner) have employed patent thickets and trial data protections to extend exclusivity, but eventually face generic biologic competition, impacting revenue projections.

Pricing and Reimbursement

• EYLEA commands premium pricing aligned with other biologics, supported by substantial clinical benefits and dosing convenience.
• Reimbursement policies across countries influence market adoption, with favorable coverage in the U.S. and Europe enabling continued high utilization rates.

Financial Trajectory and Revenue Outlook

Historical Performance

Regeneron’s financial reports reveal that EYLEA consistently accounted for approximately 50-60% of its total revenues in recent years. In 2022, EYLEA generated about $4.1 billion globally, reflecting its solid market penetration and expanding indications [3].

Projected Growth and Challenges

• Near to Mid-Term (Next 3-5 Years): The revenue trajectory is expected to remain steady, supported by existing approved indications, ongoing geographic expansion, and a strong pipeline of clinical trials for new ocular and systemic indications.
• Patent Cliff Impact: The impending patent expirations could lead to a decline in sales, unless offset by biosimilar competition, new formulations, or expanded indications.
• Pipeline and Pipeline Products: Regeneron’s ongoing R&D efforts, including potential longer-acting formulations and combination therapies, aim to extend the drug’s lifecycle and mitigate patent expiry impacts.
• Market Penetration in Developing Countries: Growing healthcare infrastructure and affordability improvements enable expansion into emerging markets, providing additional revenue streams.

Emerging Opportunities and Threats

Opportunities

• New Indications: Conditions like diabetic retinopathy and retinal vein occlusion (RVO) are under clinical evaluation, potentially broadening EYLEA’s indications.
• Innovative Formulations: Developments in sustained-release implants or gene therapies could redefine treatment paradigms, affecting EYLEA’s market share either positively (through label expansion) or negatively (via displacement).

Threats

• Biologics Biosimilarization: Entry of biosimilars post-patent expiration poses significant pricing and market share risks.
• Competitive Agents: Brolucizumab and other emerging therapies with comparable or superior efficacy profiles threaten EYLEA’s market dominance.
• Regulatory Changes: Modifications in reimbursement policies or approval pathways could impact pricing strategies and revenue growth.

Strategic Implications for Stakeholders

For pharmaceutical companies, financial investors, and healthcare providers, the outlook on EYLEA underscores the necessity to monitor patent statuses, competitive launches, and technological innovations. Strategic investments in pipeline diversification and partnerships could offset revenue vulnerabilities. Moreover, early adoption of biosimilar manufacturing and market access strategies may influence profitability post-Patent expiration.

Key Takeaways

• EYLEA remains a pivotal therapy in ophthalmology with sustained demand driven by demographic trends and clinical efficacy.
• Patent expirations pose imminent challenges, yet strategic patent protections and pipeline developments will shape its future revenue trajectory.
• Competition from biosimilars and next-generation biologics are critical factors impacting market share and pricing strategies.
• Expanding indications and geographic reach present growth opportunities, particularly in emerging markets.
• Continuous innovation and regulatory navigation are essential to maintain EYLEA’s financial performance and market leadership.

Conclusion

EYLEA’s market dynamics and financial trajectory are characterized by a combination of robust current performance, strategic patent protection, and impending competitive pressures. While near-term revenues are forecasted to stabilize, long-term growth hinges on pipeline innovation, expansion into new indications, and adept navigation of biosimilar competition. Stakeholders must adopt comprehensive strategies that leverage EYLEA’s strengths while mitigating risks associated with market expiration and innovation gaps.

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FAQs

1. When will EYLEA face biosimilar competition in the United States?
   Biosimilar versions of aflibercept are anticipated post-2024, following patent expiration and patent litigation outcomes.

2. What are the key advantages of EYLEA over its competitors?
   EYLEA offers extended dosing intervals, proven efficacy across multiple retinal conditions, and a well-established safety profile, contributing to higher patient compliance and clinician preference.

3. Are there ongoing clinical trials that could expand EYLEA's use?
   Yes, several trials are evaluating EYLEA in indications such as diabetic retinopathy and systemic vascular conditions, which could broaden its therapeutic scope.

4. How does the patent landscape influence EYLEA’s future revenue?
   Patent protections currently underpin EYLEA’s exclusivity. As these expire, biosimilar competition may lead to revenue erosion unless countered with alternative strategies like product innovation.

5. What growth opportunities exist in emerging markets for EYLEA?
   Increased healthcare infrastructure and awareness, coupled with rising prevalence of ocular diseases, present significant potential for EYLEA’s expansion in regions such as Asia-Pacific, Latin America, and the Middle East.

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Sources

[1] Grand View Research, Ophthalmology Drugs Market Size & Trends, 2022-2027.

[2] World Health Organization, Ageing and Health, 2021.

[3] Regeneron Pharmaceuticals Inc. Quarterly Financial Reports, 2022.