EYLEA Drug Profile

Summary for Tradename: EYLEA

High Confidence Patents:	13
Applicants:	1
BLAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EYLEA

Recent Litigation for EYLEA

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.	2024-09-24
Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.	2024-06-20
Novartis Pharma AG v. Regeneron Pharmaceuticals, Inc.	2023-01-05

See all EYLEA litigation

PTAB Litigation

Petitioner	Date
Regeneron Pharmaceuticals, Inc. et al.	2021-04-16
Regeneron Pharmaceuticals, Inc.	2020-07-16
Regeneron Pharmaceuticals, Inc. et al.	2020-07-16

See all EYLEA litigation

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. 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 EYLEA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for EYLEA Derived from 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	Company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2038-10-12	Company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2039-04-29	Company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2039-09-25	Company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2040-01-10	Company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2041-06-21	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		2032-05-15	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2034-11-25	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2036-04-22	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2034-03-18	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2036-04-22	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2032-12-05	Patent claims search

International Patents for EYLEA

Country	Patent Number	Estimated Expiration
Canada	2654510
Denmark	2364691
Hong Kong	1185798
Canada	2621047
Brazil	PI0713749
European Patent Office	1947118

Supplementary Protection Certificates for EYLEA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
132013902154380	Italy		PRODUCT NAME: AFLIBERCEPT(EYLEA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/797/001-002, 20121122
PA2013009,C1183353	Lithuania		PRODUCT NAME: AFLIBERCEPTUM; REGISTRATION NO/DATE: EU/1/12/797/001-002 20121122
CA 2013 00020	Denmark
122013000041	Germany		PRODUCT NAME: AFLIBERCEPT; REGISTRATION NO/DATE: EU/1/12/797/001-002 20121122
2013C/029	Belgium		PRODUCT NAME: AFLIBERCEPT; AUTHORISATION NUMBER AND DATE: EU/1/12/197/001 20121126
20/2013	Austria		PRODUCT NAME: AFLIBERCEPT; REGISTRATION NO/DATE: EU/1/12/797/001 UND 002 20121122

Market Dynamics and Financial Trajectory of EYLEA

Introduction

EYLEA (aflibercept) is a revolutionary anti-vascular endothelial growth factor (Anti-VEGF) medication used to treat various eye disorders, including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema following retinal vein occlusion (RVO). Here, we delve into the market dynamics and financial trajectory of EYLEA, highlighting key drivers, challenges, and future outlook.

Market Size and Growth

The global EYLEA drug market is projected to grow significantly, reaching US$ 14.30 billion by 2030 from US$ 8.79 billion in 2023, with a compound annual growth rate (CAGR) of 7.2% during the forecast period[1][4].

Key Drivers

Increasing Prevalence of Eye Diseases

The rising prevalence of age-related macular degeneration (AMD) and diabetic retinopathy, particularly among the elderly population, is a major driver of the EYLEA market. The growing incidence of diabetes globally has also led to an increase in diabetic macular edema (DME), further driving demand for EYLEA[1][4].

Growing Geriatric Population

The increasing geriatric population, which is more susceptible to eye disorders, is another significant factor fueling the demand for EYLEA. This demographic shift is expected to continue driving market growth[1][4].

Strong Clinical Efficacy Profile

EYLEA's strong clinical efficacy profile in treating retinal diseases has made it a preferred treatment option. Its ability to improve vision and reduce the risk of blindness in patients has contributed to its market success[1][4].

Favorable Reimbursement Policies

The availability of favorable reimbursement policies for EYLEA injections has also propelled market growth. These policies make the treatment more accessible to patients, thereby increasing its adoption rate[1][4].

Market Challenges

Side Effects

One of the key challenges facing the EYLEA market is the side effects associated with the drug. Reducing these side effects during the manufacturing process is crucial for broader acceptance and market growth[1].

Pricing Pressures and Patent Expirations

The EYLEA market faces pricing pressures and the impending expiration of the brand's patent in 2025. This could lead to the emergence of biosimilars, which may challenge the market dominance of EYLEA[4].

Competition from Alternative Treatments

The introduction of alternative treatments, such as Roche's Vabysmo, has already started to impact EYLEA's market share. For instance, Vabysmo has won market share, leading to decreases in EYLEA sales in certain quarters[3].

Regional Insights

North America

North America is the largest market for EYLEA, driven by the presence of well-established healthcare infrastructure, higher healthcare spending, and a growing geriatric population[1][4].

Asia-Pacific

The Asia-Pacific region is expected to exhibit significant growth opportunities due to improving access to healthcare and rising awareness about retinal disorders. This region is forecasted to be the fastest-growing market for EYLEA[1][4].

Financial Performance

Revenue Growth

Regeneron Pharmaceuticals, one of the major players in the EYLEA market, reported a 3% increase in total EYLEA HD and EYLEA net product sales in the U.S. for the third quarter of 2024 compared to the same period in 2023. Despite challenges from alternative treatments, the overall EYLEA franchise has maintained its revenue levels[2].

New Product Launches

The FDA approval of EYLEA HD in the third quarter of 2023 has been a significant financial boost. EYLEA HD generated $504 million in sales in the first half of 2024, helping Regeneron maintain its revenue from the EYLEA franchise[3].

Future Outlook

Expanding Therapeutic Applications

Ongoing research and development efforts are focused on expanding the therapeutic applications of EYLEA and improving treatment outcomes. Advancements in precision medicine and personalized therapies hold potential for tailoring EYLEA treatment regimens to individual patient needs[4].

Strategic Collaborations

Strategic collaborations between pharmaceutical companies and healthcare providers are expected to facilitate the development of innovative care models and patient support programs. These collaborations can drive market penetration and patient engagement[4].

Market Segmentation

The EYLEA market is segmented by indication (wet AMD, DME, DR, RVO, etc.) and by end-user (hospitals, ophthalmic clinics, etc.). Understanding these segments is crucial for targeted marketing and distribution strategies[4].

Key Players

The major players in the EYLEA market include Bayer, Regeneron Pharmaceuticals, Coherus BioSciences, Inc., and Klinge Biopharma. These companies are engaged in intense competition, leading to strategic collaborations, mergers, and acquisitions to maintain market share[1][4].

Conclusion

The global EYLEA drug market is poised for significant growth driven by increasing prevalence of eye diseases, a growing geriatric population, and strong clinical efficacy. However, the market faces challenges such as side effects, pricing pressures, and competition from alternative treatments. Strategic collaborations, expanding therapeutic applications, and favorable reimbursement policies will be key to navigating these challenges and maintaining market dominance.

Key Takeaways

• The global EYLEA drug market is expected to reach US$ 14.30 billion by 2030, growing at a CAGR of 7.2%.
• Increasing prevalence of eye diseases and a growing geriatric population are major drivers.
• Side effects and competition from alternative treatments are key challenges.
• North America is the largest market, while Asia-Pacific is expected to be the fastest-growing region.
• Strategic collaborations and expanding therapeutic applications are crucial for future growth.

FAQs

What is the expected market size of the EYLEA drug market by 2030?

The global EYLEA drug market is expected to reach US$ 14.30 billion by 2030[1][4].

What are the major factors driving the EYLEA drug market growth?

The major factors include increasing prevalence of eye diseases, a growing geriatric population, and strong clinical efficacy of EYLEA[1][4].

Which region will lead the EYLEA drug market?

North America will lead the EYLEA drug market, while Asia-Pacific is expected to be the fastest-growing region[1][4].

What are the key challenges facing the EYLEA market?

Key challenges include side effects, pricing pressures, patent expirations, and competition from alternative treatments[1][4].

Who are the major players in the EYLEA drug market?

The major players include Bayer, Regeneron Pharmaceuticals, Coherus BioSciences, Inc., and Klinge Biopharma[1][4].

Sources

1. Global EYLEA Drug Market Size & Share Analysis - Growth Trends. CoherentMI.
2. Regeneron Reports Third Quarter 2024 Financial and Operating Results. Regeneron.
3. Roche and Regeneron Square Off in Lucrative Eye Disease Market. BioSpace.
4. Understanding the Global EYLEA Drug Market: Trends and Insights 2023-2030. EIN Presswire.
5. Regeneron Reports Fourth Quarter and Full Year 2023 Financial Results. Regeneron.