Aflibercept - Biologic Drug Details

Summary for aflibercept

Tradenames:	2
High Confidence Patents:	13
Applicants:	1
BLAs:	2
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for aflibercept

Recent Clinical Trials for aflibercept

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Ahmad Zeeshan Jamil	PHASE4
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	PHASE4
Sahiwal medical college sahiwal	PHASE4

See all aflibercept clinical trials

Pharmacology for aflibercept

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 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 aflibercept Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for aflibercept 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
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2038-08-06	DrugPatentWatch analysis and company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2039-04-29	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for aflibercept 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
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2038-05-25	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2036-06-13	Patent claims search

International Patents for aflibercept

Country	Patent Number	Estimated Expiration
China	118494967
Brazil	112021025769
Australia	2020323937
Israel	296864
Japan	2019150037
Singapore	10201707153U

Supplementary Protection Certificates for aflibercept

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
20/2013	Austria		PRODUCT NAME: AFLIBERCEPT; REGISTRATION NO/DATE: EU/1/12/797/001 UND 002 20121122
CR 2013 00020	Denmark		PRODUCT NAME: AFLIBERCEPT; REG. NO/DATE: EU/1/797/001-002 20121122
C300588	Netherlands		PRODUCT NAME: AFLIBERCEPT; REGISTRATION NO/DATE: EU/1/12/797/001-002 20121122
SPC/GB13/028	United Kingdom		PRODUCT NAME: AFLIBERCEPT; REGISTERED: UK EU/1/12/797/001 20121122; UK EU/1/12/797/002 20121122
C01183353/01	Switzerland		PRODUCT NAME: AFLIBERCEPT; REGISTRATION NO/DATE: SWISSMEDIC 62397 29.10.2012
2013/016	Ireland		PRODUCT NAME: AFLIBERCEPT; REGISTRATION NO/DATE: EU/1/12/797/001-002 20121122

Market Dynamics and Financial Trajectory for Aflibercept

Last updated: February 20, 2026

Aflibercept, marketed primarily as Eylea, is a biologic drug used to treat various indications including neovascular age-related macular degeneration (wet AMD), diabetic macular edema (DME), diabetic retinopathy, and myopic choroidal neovascularization. It operates as a VEGF trap, inhibiting angiogenesis and vascular permeability.

Market Size and Growth Drivers

The global ophthalmic drug market was valued at approximately $16 billion in 2022, with biologics accounting for a significant portion due to rising prevalence of retinal diseases. Aflibercept's dominant position in anti-VEGF therapies reflects its efficacy and adoption.

Key Growth Factors:

• Increasing prevalence of AMD, DME, and diabetic retinopathy.
• Aging populations in developed markets.
• Advances in injection techniques and treatment protocols.
• Expanded indications, including new retinal diseases.

Market Penetration

Since introduction by Regeneron Pharmaceuticals in 2011 and approval by the FDA, aflibercept has captured an estimated 25-30% market share in anti-VEGF therapies, competing chiefly with ranibizumab and bevacizumab.

Revenue and Sales Trajectory

Historical Performance

• 2017: $4.8 billion worldwide.
• 2020: $6.1 billion.
• 2022: ~$6.8 billion, reflecting steady growth.

Key Regional Trends

• North America: 50% of sales.
• Europe: 25%.
• Asia-Pacific: Growing rapidly, with a CAGR of 10% from 2018 to 2022.

Sales Drivers

• Increased frequency of treatment in disclosed protocols (monthly injections for AMD).
• Introduction of long-acting formulations (e.g., aflibercept biosimilars).
• Patient adherence improvements with less frequent injections.

Competitive Landscape

Main Competitors:

• Ranibizumab (Lucentis): Similar efficacy, slightly higher market share (~30%).
• Bevacizumab (Avastin): Lower cost, larger off-label use.
• Brolucizumab (Leucovorin): Emerging, approved in 2019, claims longer duration.

Market Dynamics

• Biosimilar Entry: Biosimilars of aflibercept are under development, targeting price-sensitive markets.
• Off-label Use: Bevacizumab continues to be used off-label due to lower cost.
• Patent Expirations: The primary patent expired in 2020 in the US, increasing biosimilar competition.

Pricing and Reimbursement

Pricing Trends:

• US list price for aflibercept is approximately $2,000 per injection.
• Biosimilars are expected to target a 20-30% discount.

Reimbursement Policies:

• Reimbursement rates vary; US commercial payers cover about 80-90% of treatment costs.
• Some countries adopt national reimbursement schemes that influence prescribing patterns.

Financial Projections

Near-Term Outlook (2023-2025)

Revenue growth expected to slow but remain positive due to:

• Market saturation in developed regions.
• Increasing adoption in emerging markets.
• Potential approval for new indications, such as retinal vein occlusion.

Long-Term Outlook (2025-2030)

• Peak sales estimated at $8 billion globally, driven by:
  • Expanded indications.
  • Introduction of biosimilars reducing costs.
  • Enhanced treatment adherence protocols.

Risks to Financial Trajectory

• Patent litigation delays or failures.
• Entry of biosimilars and generics.
• Cost containment measures by payers.

Regulatory and Policy Influences

• US FDA approved aflibercept in 2011.
• European Medicines Agency (EMA) approved in 2011.
• Biosimilar approvals in Asia and Europe from 2023 onwards.

Summary

Aflibercept remains a leading biologic in ophthalmology with consistent sales growth driven by its clinical efficacy and expanding indications. Its market faces increasing competition from biosimilars and off-label options, with pricing pressures likely to moderate revenue growth in mature markets. Emerging markets and new indications hold potential for future expansion. Patent expirations and biosimilar developments are primary factors influencing market dynamics and the drug’s financial trajectory.

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Key Takeaways

• Aflibercept generated approximately $6.8 billion worldwide in 2022, with steady growth.
• Its market share in anti-VEGF therapies is around 25-30%, primarily in developed markets.
• Patent expiration in 2020 opened the market for biosimilars, increasing competitive pressure.
• Revenue growth is projected to plateau near $8 billion by 2030 due to market saturation and biosimilar entry.
• Pricing and reimbursement policies significantly influence market penetration and future revenue.

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Frequently Asked Questions

1. How does aflibercept compare to other anti-VEGF therapies in efficacy?
Aflibercept has demonstrated comparable or superior efficacy to ranibizumab in several clinical trials, with some data indicating longer dosing intervals can reduce treatment burden.

2. What is the impact of biosimilar entry on aflibercept's revenue?
Biosimilars are expected to lower prices by 20-30%, reducing revenue margins but potentially increasing volume of treatment in cost-sensitive markets.

3. Are there upcoming indications that could expand aflibercept’s use?
Potential approvals include retinal vein occlusion and other vascular retinal diseases, which could expand the addressable market by approximately 10-15%.

4. How do reimbursement policies differ internationally?
US payers reimburse around 80-90%, while in Europe, reimbursement varies by country, often subsidized through national health systems, affecting patient access and prescribing.

5. What are the main risks to aflibercept’s long-term financial outlook?
Patent expiration, biosimilar competition, cost containment policies, and off-label use of cheaper alternatives pose ongoing risks.

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References

[1] MarketsandMarkets. (2023). Ophthalmic Drugs Market - Global Forecast to 2028.