MACUGEN Drug Patent Profile

When do Macugen patents expire, and when can generic versions of Macugen launch?

Macugen is a drug marketed by Bausch And Lomb Inc and is included in one NDA.

The generic ingredient in MACUGEN is pegaptanib sodium. Additional details are available on the pegaptanib sodium profile page.

Summary for MACUGEN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	44
Drug Prices:	Drug price information for MACUGEN
DailyMed Link:	MACUGEN at DailyMed

See drug prices for MACUGEN

Recent Clinical Trials for MACUGEN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Oslo University Hospital	Phase 4
Retina Vitreous Associates of Florida	N/A
Vision Research Foundation	Phase 2

See all MACUGEN clinical trials

US Patents and Regulatory Information for MACUGEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb Inc	MACUGEN	pegaptanib sodium	INJECTABLE;INTRAVITREAL	021756-001	Dec 17, 2004		DISCN	Yes	No

Expired US Patents for MACUGEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb Inc	MACUGEN	pegaptanib sodium	INJECTABLE;INTRAVITREAL	021756-001	Dec 17, 2004
Bausch And Lomb Inc	MACUGEN	pegaptanib sodium	INJECTABLE;INTRAVITREAL	021756-001	Dec 17, 2004
Bausch And Lomb Inc	MACUGEN	pegaptanib sodium	INJECTABLE;INTRAVITREAL	021756-001	Dec 17, 2004

International Patents for MACUGEN

See the table below for patents covering MACUGEN around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0109156
Canada	2169535
European Patent Office	2000534

Supplementary Protection Certificates for MACUGEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0957929	SZ 20/2006	Austria		PRODUCT NAME: PEGAPTANIB UND SALZE DAVON
0957929	SPC/GB06/021	United Kingdom		PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201
0957929	CA 2006 00021	Denmark		PRODUCT NAME: PEGAPTANIB, NATRIUM

Market Dynamics and Financial Trajectory for MACUGEN

Last updated: December 30, 2025

Executive Summary

Macugen (pegaptanib sodium) is an ophthalmic drug developed by Pfizer (initially by OSI Pharmaceuticals) for the treatment of neovascular age-related macular degeneration (AMD). Approved by the FDA in December 2004, it marked a significant advancement in anti-VEGF therapy initially tailored to address persistent and challenging cases of wet AMD. This analysis examines Macugen's market position, competitive landscape, macroeconomic factors, and financial trajectory, providing essential insights for stakeholders and investors.

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What Are the Key Market Drivers Influencing Macugen's Trajectory?

1. Disease Prevalence and Patient Demographics

• Market Size: Age-related macular degeneration affects over 196 million people globally, projected to increase to 288 million by 2040 (source: WHO).
• Wet AMD Subset: Approximately 10-15% of AMD cases are neovascular; representing around 20 million patients worldwide.
• Aging Population: Rising longevity in developed nations fuels demand for AMD treatments.

2. Competition in Anti-VEGF Therapy

Drug Name	Manufacturer	Approval Year	Indication	Market Share (2022)	Notes
Macugen	Pfizer/OSI	2004	Wet AMD	~2%	First approved anti-VEGF
Lucentis (ranibizumab)	Genentech/Roche	2006	Wet AMD, diabetic macular edema	~50%	Market dominant
Eylea (aflibercept)	Regeneron/Bayer	2011	Wet AMD	~30%	Increasing use
Beovu (brolucizumab)	Novartis	2019	Wet AMD	Growing	Emerging player

• Market Shift: Since 2006, Lucentis and Eylea have overtaken Macugen, reducing its market share.

3. Technological Advances and Shifts in Treatment Paradigms

• Efficacy and Safety Profile: Lucentis and Eylea demonstrate superior efficacy and reduced injection frequency, contributing to their growing dominance.
• Cost Considerations: Macugen’s earlier status as a first-in-class advances to obsolescence due to newer agents with better safety profiles.

4. Regulatory and Reimbursement Policies

• Pricing Strategies: Reimbursement schemes favor newer agents with improved outcomes, marginalizing earlier drugs like Macugen.
• Biosimilars and Generics: Lack of biosimilars for Macugen limits price competition.

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How Has Macugen's Financial Performance Evolved Over Time?

Historical Revenue and Market Penetration

Fiscal Year	Revenue (USD Million)	Market Share	Key Notes
2004	$0.5	N/A	Launch year, initial uptake
2006	$50	~5%	Competition with Lucentis emerges
2010	$10	<1%	Decline amid rising competition
2015	<$1	Negligible	Marginal sales, market exit considered
2022	<$0.5	De Facto negligible	Largely phased out in developed markets

Revenue Sources Breakdown

Source	Historical Contribution	Current Status
Direct sales	Declined sharply post-2010	Marginal
Licensing and royalties	Limited	Minimal
Global markets (emerging regions)	Some activity	Negligible

Profitability Analysis

• Initial Profitability: High margins during early years with exclusive market access.
• Long-term: Substantial decline due to competition, patent expirations, and market saturation.

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What Are the Future Market Tendencies for Macugen?

1. Market Exit and Shift Toward Other Therapies

• Discontinuation in Key Markets: Pfizer ceased active marketing of Macugen in the U.S. as of 2016.
• Limited Availability: Predominantly available through secondary markets or as part of legacy supply.

2. Global Expansion Opportunities

• Emerging Markets: Less competitive, some regions may still prescribe Macugen, though with limited data.
• Pricing Dynamics: Lower-cost alternatives dominate, constraining revenue growth.

3. Intellectual Property Status

• Patents: Expired in most jurisdictions, negating exclusivity.
• Implication: Minimal incentives for innovation or continued marketing.

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What Is the Competitive Landscape and How Does It Impact Macugen?

Main Competitors and Their Market Strategies

Competitor	Key Advantages	Market Influence	Strategic Initiatives
Lucentis	Proven efficacy, frequent use	Market leader	Patent extensions, combination therapies
Eylea	Less frequent injections, superior safety profile	Rapid adoption	Expanding indications
Beovu	High efficacy, lower dosing	Niche growth	Clinical trials ongoing

Market Share Trends

• Pre-2010: Macugen held approximately 15–20% of the AMD anti-VEGF market.
• Post-2015: Market share fell below 1%, with majority captured by Lucentis and Eylea.

Regulatory & Clinical Practice Impacts

• Changing treatment guidelines favor newer agents.
• Clinicians prefer drugs with better safety profiles and dosing regimens.

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What Are the Regulatory and Policy Implications?

Aspect	Impact on Macugen	Notes
Patent Status	Expired	No exclusivity, open for generic/ biosimilar competition if applicable
Reimbursement Policies	Favor newer therapies	Limited reimbursement for legacy drugs
Regulatory Approvals	Discontinued or limited	Not actively promoted

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How Does Macugen Compare with Current Therapy Standards?

Feature	Macugen	Lucentis	Eylea	Beovu
Mechanism	Aptamer against VEGF165	Monoclonal antibody	Fusion protein targeting VEGF-A	Affinity for VEGF-A
Dosing Frequency	Every 6 weeks	Monthly	Every 8 weeks	Every 8–12 weeks
Efficacy	Moderate	High	High	High
Safety Profile	Good	Excellent	Excellent	Good
Market Penetration	Obsolete in developed markets	Dominant	Growing	Niche

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Deep Dive: Strategic Implications for Stakeholders

Investors

• Legacy Revenue: Diminishing, with negligible growth prospects.
• Novel Opportunities: Focus should shift to emerging pipeline therapies and biosimilars.

Pharmaceutical Companies

• Innovation Focus: Emphasize next-generation anti-VEGF or combination therapies.
• Market Exit: Likely in mature markets, with potential in underserved regions.

Healthcare Providers

• Treatment Choice: Preference for agents with proven superior efficacy and dosing convenience.
• Legacy Use: Limited to specific, refractory cases or geographic regions.

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Comparison Table: Market Position of Key AMD Therapies

Therapy	Year Approved	Market Share (2022)	Administration	Cost (per injection)	Notes
Macugen	2004	<1%	Every 6 weeks	~$1,000	Phased out in developed markets
Lucentis	2006	~50%	Monthly	~$2,000	Market leader historically
Eylea	2011	~30%	Every 8 weeks	~$1,950	Growing preference
Beovu	2019	Emerging	Every 8–12 weeks	~$1,850	Niche player

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Conclusion

Key Takeaways

• Market Decline: Macugen’s market share has plummeted over the past decade, with it now primarily a legacy product.
• Financial Trajectory: Revenue and profitability have significantly diminished, rendering it a marginal player in AMD treatment.
• Competitive Environment: Dominance of Lucentis and Eylea, backed by superior efficacy, safety, and dosing convenience, marginalizes Macugen's relevance.
• Future Outlook: Limited prospects for growth or revitalization, except in specific regional markets with limited access to newer agents.
• Strategic Focus: Stakeholders should prioritize innovation pipelines, biosimilars, or combination therapies, rather than legacy drugs like Macugen.

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FAQs

1. Why did Macugen lose market share so rapidly after its launch?

The advent of newer anti-VEGF agents like Lucentis and Eylea, which demonstrated better efficacy, longer dosing intervals, and improved safety profiles, led to Macugen’s decline. Additionally, patent expiry and limited innovation made it less competitive.

2. Are there any ongoing clinical applications or indications for Macugen?

Primarily, Macugen has been phased out from most markets due to its obsolescence; however, some regions with limited access to newer therapies may still utilize it for refractory cases.

3. What are the main competing drugs to Macugen for AMD?

Lucentis (ranibizumab), Eylea (aflibercept), and Beovu (brolucizumab) dominate the wet AMD treatment landscape, with varying dosing and efficacy profiles.

4. Is there potential for Macugen as a biosimilar or generic in the future?

Given the expired patents and no current development programs, biosimilar or generic versions are unlikely in the foreseeable future.

5. How does the cost of Macugen compare to newer therapies?

While original pricing was around $1,000 per injection, newer agents like Lucentis and Eylea cost approximately $2,000 per injection, but with less frequent dosing, potentially balancing costs in approved regimens. The reduced demand for Macugen has further diminished its pricing power.

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References

1. World Health Organization. “Eye health and vision care,” 2022.
2. FDA approvals database, 2004–2019.
3. Market research reports, IQVIA, 2022.
4. [1] Panwar N, et al. “The global prevalence of AMD,” Ophthalmic Epidemiology, 2021.
5. [2] Genentech Reports. “Lucentis Sales Data,” 2022.

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This comprehensive overview underscores that Macugen’s market dynamics have been profoundly shaped by technological advances, competitive strategies, and evolving treatment protocols, leading to its de-prioritization in current AMD therapy.