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
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
European Patent Office	1564290	Procédé d'identification de ligands à acide nucléique pour des cibles tissulaires (Method for identifying nucleic acid ligands of tissue targets)
Japan	2002503455
Australia	7373096
Austria	160821
European Patent Office	1683871	Ligands d'acides nucléiques et procédé de leur production (Nucleic acid ligands and methods for producing the same)

Supplementary Protection Certificates for MACUGEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0957929	PA2006004,C0957929	Lithuania		PRODUCT NAME: PEGAPTANIBUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131
0957929	300234	Netherlands		300234, 20171017, EXPIRES: 20210130
0957929	SZ 20/2006	Austria		PRODUCT NAME: PEGAPTANIB UND SALZE DAVON
0957929	PA2006004	Lithuania		PRODUCT NAME: PEGAPTANIBUM; REG. NO/DATE: EU/1/05/325/001 20060131
0957929	132006901428637	Italy		PRODUCT NAME: PEGAPTANIB SODICO(MACUGEN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/05/325/001, 20060131

Market Dynamics and Financial Trajectory for MACUGEN

Last updated: July 30, 2025

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Introduction

MACUGEN (Pegaptanib sodium) is an injectable anti-vascular endothelial growth factor (VEGF) agent developed by Eyetech Pharmaceuticals, subsequently acquired by Pfizer. Approved by the US Food and Drug Administration (FDA) in 2004, MACUGEN addresses neovascular (wet) age-related macular degeneration (AMD), one of the leading causes of vision loss among the elderly. Despite its initial market entry, the drug's positioning, competitive landscape, and evolving treatment paradigms continue to shape its market dynamics and financial trajectory.

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Market Overview: Therapeutic Landscape and Demand Drivers

1. Overview of AMD and Market Need

Neovascular AMD affects approximately 10 million individuals globally, with incidence rising due to aging populations—particularly in North America, Europe, and parts of Asia. The disease’s progression results in rapid and irreversible central vision loss, prompting demand for effective intravitreal therapies that inhibit abnormal blood vessel growth.

2. Competitive Landscape

Initially, Macugen faced competition primarily from Lucentis (ranibizumab), approved in 2006, and later from Eylea (aflibercept), both of which demonstrated superior efficacy and broader indications. These agents quickly gained market share, relegating MACUGEN to a niche position for specific patient subsets, especially those intolerant or unresponsive to alternative treatments.

3. Market Penetration and Adoption Patterns

Despite being the first anti-VEGF therapy for AMD, Macugen’s adoption remained modest compared to subsequent agents. Its stability in the market was limited by relatively modest efficacy and less favorable dosing convenience (weekly injections initially, then monthly). Physicians shifted preference to agents with higher visual acuity gains and more flexible dosing schedules, such as ranibizumab and aflibercept.

4. Demographic and Societal Drivers

The global aging population continues to elevate AMD prevalence, sustaining underlying demand. However, treatment patterns now favor quick-onset, high-efficacy drugs, limiting Macugen’s growth potential. Additionally, increased awareness and earlier diagnosis amplify the demand for more effective therapies, further constraining Macugen’s market share.

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Market Dynamics

1. Competitive Responses and Market Shifts

The aggressive entry of newer anti-VEGF therapies altered the treatment landscape. Phase III trials established superior visual outcomes with ranibizumab and aflibercept, leading to their preferential use. Macugen's market share decline accelerated as clinicians prioritized agents with proven higher efficacy and more convenient administration protocols.

2. Regulatory and Labeling Developments

Though initially approved for AMD, labeling restrictions, limited new indications, and the absence of approvals for broader age-related ocular conditions reduced therapeutic versatility, impacting sales longevity.

3. Pricing and Reimbursement Trends

While hardware and manufacturing processes sustained Macugen’s pricing, shift towards more efficacious agents resulted in reimbursement cuts and competitive pricing pressures, suppressing profit margins and revenue potential.

4. Patent and Market Exclusivity

Macugen’s patent exclusivity ended in the early 2010s, opening pathways for biosimilar or generic competition that further eroded its market share and financial prospects.

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Financial Trajectory

1. Revenue Trends

Pfizer’s financial filings indicated that Macugen’s revenues peaked shortly after its launch, with a gradual decline evident from 2008 onward. The shift in treatment paradigms and clinical competition reduced prescription volume substantially.

2. R&D and Lifecycle Considerations

Limited pipeline development and lack of significant modifications constrained long-term growth. Pfizer's strategic focus shifted away from Macugen toward higher-growth assets, reducing investment and promotional efforts.

3. Market Valuation

As of 2023, Macugen's contribution to Pfizer's top-line remains marginal, with revenues declining to low single-digit million-dollar figures annually. Its role has transitioned primarily to a niche or legacy product, lacking substantial growth prospects.

4. Impact of Biosimilars and Generics

Although biosimilars for Macugen are not yet available, ongoing patent expirations for anti-VEGF agents cast uncertainty over the entire intravitreal injection class, indirectly influencing Macugen’s future market viability.

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Future Outlook and Strategic Considerations

Given the current landscape, Macugen faces limited growth opportunities. Nonetheless, niche positioning may persist in cases where patients exhibit specific resistance or intolerance to other anti-VEGF therapies. Pfizer might explore combination therapies, formulation enhancements, or adjunctive indications to extend its financial relevance.

Emerging therapies—such as gene editing, sustained-release devices, and novel anti-angiogenic agents—add competitive pressure, potentially diminishing the role of older drugs like Macugen further. Therefore, its financial trajectory may continue downward unless strategic repositioning occurs.

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Key Market Factors Impacting Macugen’s Future

• Patient Demographics: Aging populations sustain disease prevalence but favor more efficacious treatments.
• Therapeutic Efficacy: Superior visual acuity improvements with newer agents overshadow Macugen’s benefits.
• Pricing Strategies: Competitive pricing may prolong niche utility but unlikely to reverse declining revenues.
• Regulatory Environment: Limited new indications restrict growth pathways.
• Technological Innovation: Novel delivery systems or combination therapies could create supplemental revenue streams.

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Conclusion

The market dynamics for MACUGEN are characterized by declining demand driven by superior competition, shifting treatment standards toward more effective and convenient therapies, and patent expirations eroding its market exclusivity. Pfizer’s financial trajectory for Macugen reflects this reality, with declining revenues and limited prospects for substantial growth. Strategically, the drug is now best considered a legacy asset, with its future constrained unless innovation or repurposing unlocks new value.

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Key Takeaways

• MACUGEN’s initial success was undermined by high-efficacy competitors like ranibizumab and aflibercept.
• The drug’s market share has steadily declined, constrained by limited efficacy, dosing frequency, and evolving standards of care.
• Patent expiration and biosimilar threats further diminish its commercial relevance.
• Future growth potential remains limited; repositioning or indications for niche populations are necessary for sustained revenue.
• Companies should monitor emerging therapies and technological innovations poised to reshape the AMD treatment landscape.

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FAQs

1. What are the primary reasons for MACUGEN’s decline in market share?
MACUGEN’s decline stems from its comparatively modest efficacy, less convenient dosing schedule, and the advent of more effective anti-VEGF agents with broader indications and better visual outcomes, such as ranibizumab and aflibercept.

2. Is MACUGEN still a commercially viable drug?
Currently, MACUGEN's revenue contribution is minimal, positioning it as a legacy product. Its viability depends on niche use cases or new clinical insights; however, market trends favor newer therapies.

3. Can MACUGEN be repositioned for other ocular conditions?
While theoretically possible, existing data and regulatory approvals limit its indications predominantly to AMD. Expanding into other indications would require significant clinical development and regulatory approvals, which may not be commercially justified.

4. How does patent expiration impact MACUGEN’s financial outlook?
Patent expiration removes exclusivity, opening the door for biosimilar competition, which could further reduce sales and profit margins, accelerating revenue decline.

5. What emerging therapies could further diminish MACUGEN’s market relevance?
Gene therapies, sustained-release ocular implants, and innovative anti-angiogenic agents are poised to redefine AMD treatment, likely overshadowing older agents like MACUGEN.

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References

[1] U.S. Food and Drug Administration. MACUGEN (Pegaptanib sodium) prescribing information. 2004.
[2] MarketWatch. "Anti-VEGF Therapies in AMD: Market Trends and Future Outlook." 2022.
[3] Pfizer Inc. Annual Reports and Financial Statements. 2004–2022.
[4] National Eye Institute. Age-Related Macular Degeneration Statistics. 2021.
[5] EvaluatePharma. “AMD therapeutic market analysis.” 2022.