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	6,113,906
Bausch And Lomb Inc	MACUGEN	pegaptanib sodium	INJECTABLE;INTRAVITREAL	021756-001	Dec 17, 2004	5,919,455
Bausch And Lomb Inc	MACUGEN	pegaptanib sodium	INJECTABLE;INTRAVITREAL	021756-001	Dec 17, 2004	6,426,335
Bausch And Lomb Inc	MACUGEN	pegaptanib sodium	INJECTABLE;INTRAVITREAL	021756-001	Dec 17, 2004	6,147,204
Bausch And Lomb Inc	MACUGEN	pegaptanib sodium	INJECTABLE;INTRAVITREAL	021756-001	Dec 17, 2004	6,051,698

International Patents for MACUGEN

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

Country	Patent Number	Title	Estimated Expiration
Czech Republic	2002365
Japan	2002534985
Germany	60042021
New Zealand	334859	Vascular endothelial growth factor (VEGF) nucleic acid ligand complexes
Australia	725590

Supplementary Protection Certificates for MACUGEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0957929	CA 2006 00021	Denmark		PRODUCT NAME: PEGAPTANIB, NATRIUM
0957929	132006901428637	Italy		PRODUCT NAME: PEGAPTANIB SODICO(MACUGEN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/05/325/001, 20060131
0957929	SPC024/2006	Ireland		SPC024/2006:, EXPIRES: 20210130
0957929	91252	Luxembourg		91252, EXPIRES: 20210131
0957929	06C0021	France		PRODUCT NAME: PEGAPTANIB SODIUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131

MACUGEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MACUGEN

Introduction

MACUGEN (pegaptanib sodium) is a significant player in the ophthalmological drug market, particularly for the treatment of neovascular age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Here, we delve into the market dynamics and financial trajectory of MACUGEN, highlighting its clinical efficacy, market performance, and financial implications.

Clinical Efficacy and Indications

MACUGEN is a pegylated anti-VEGF aptamer that binds to vascular endothelial growth factor (VEGF), a protein involved in angiogenesis and increased permeability, which are key factors in vision loss associated with AMD and DME[1].

• Wet AMD: MACUGEN is approved in the United States and Europe for the treatment of neovascular age-related macular degeneration. Clinical trials have shown that MACUGEN significantly improves vision in patients with wet AMD, maintaining and expanding vision gains over two years[1].
• Diabetic Macular Edema (DME): Phase 3 studies demonstrated that MACUGEN improved vision in patients with DME, a complication of diabetes that is a leading cause of blindness. The study showed that 37% of patients treated with MACUGEN gained two lines or 10 letters of vision on the ETDRS eye chart at 54 weeks, compared to 20% of those receiving a sham procedure[1].

Market Dynamics

The market for AMD drugs is robust and growing, driven by several key factors:

Increasing Prevalence of AMD

The global age-related macular degeneration drugs market is expected to grow from USD 10.46 billion in 2024 to USD 17.37 billion by 2029, with a CAGR of 10.7%. This growth is fueled by the increasing prevalence of AMD due to aging populations and unhealthy lifestyles[3].

Regional Growth

The North American region is anticipated to register the fastest growth in the AMD drugs market, driven by a large and aging population and frequent approvals of new AMD treatments. Approximately 200,000 new cases of AMD are reported annually in the US[3].

Competitive Landscape

MACUGEN competes with other anti-VEGF drugs such as Eylea, Lucentis, and Vabysmo, which dominate the market. However, MACUGEN's unique mechanism as a pegylated anti-VEGF aptamer positions it as a viable alternative in the treatment of wet AMD and DME[3].

Financial Performance

The financial trajectory of MACUGEN is closely tied to its market performance and the overall dynamics of the AMD drugs market.

Revenue Projections

In 2005, the net product revenue for MACUGEN was projected to be between $175 million and $190 million, with actual revenues reported to be around $183 million to $185 million[2].

Market Share and Competition

Despite the dominance of other anti-VEGF drugs, MACUGEN has maintained a significant market presence. However, the off-label use of cheaper alternatives like Avastin has impacted the market share of more expensive drugs, including MACUGEN. Avastin captures about 50% of the treatment volume for wet AMD, affecting the revenue of more expensive treatments[3].

Pricing and Regulatory Considerations

The introductory price of MACUGEN in Canada was found to be within the guidelines set by the Patented Medicine Prices Review Board (PMPRB), as it did not exceed the median of international prices. This pricing strategy helps in maintaining market competitiveness while ensuring regulatory compliance[4].

Challenges and Opportunities

The market for MACUGEN faces several challenges and opportunities:

Challenges

• High Treatment Burden: Frequent intravitreal injections are a significant challenge, leading to patient non-adherence and reducing treatment efficacy[3].
• Off-Label Use: The use of Avastin as an off-label treatment for wet AMD reduces the market share for more expensive drugs like MACUGEN[3].

Opportunities

• Novel Drug Modalities: The development of novel drug modalities such as gene therapies and oral inhibitors offers opportunities to reduce treatment costs and improve patient adherence[3].
• Expanding Indications: The potential approval for additional indications, such as DME, expands the market for MACUGEN and addresses unmet medical needs[1].

Financial Guidance and Company Performance

Pfizer, which markets MACUGEN outside the US, has reported significant financial performance in the pharmaceutical sector. However, the specific financial guidance for MACUGEN is often integrated into broader company reports.

• Pfizer's Financial Performance: In 2008, Pfizer reported total pharmaceutical revenues of $44.174 billion, with a focus on cost-reduction initiatives that positively impacted their financial performance[5].

Key Takeaways

• Clinical Efficacy: MACUGEN has demonstrated significant improvement in vision for patients with wet AMD and DME.
• Market Growth: The AMD drugs market is growing rapidly, driven by increasing prevalence and advancements in treatments.
• Financial Performance: MACUGEN's revenue is influenced by market competition, off-label drug use, and regulatory pricing.
• Challenges and Opportunities: High treatment burden and off-label use are challenges, while novel drug modalities and expanding indications offer opportunities.

FAQs

1. What is MACUGEN used for? MACUGEN is used for the treatment of neovascular age-related macular degeneration (wet AMD) and has shown potential in treating diabetic macular edema (DME).

2. How does MACUGEN work? MACUGEN is a pegylated anti-VEGF aptamer that binds to vascular endothelial growth factor (VEGF), preventing the formation of new blood vessels and reducing permeability, which are key factors in vision loss.

3. What are the key drivers of the AMD drugs market? The key drivers include the increasing prevalence of AMD, advancements in research and development, and improvements in reimbursement policies.

4. How does the off-label use of Avastin impact MACUGEN? The off-label use of Avastin significantly reduces the market share for more expensive drugs like MACUGEN, capturing about 50% of the treatment volume for wet AMD.

5. What are the future opportunities for MACUGEN? Future opportunities include the development of novel drug modalities, potential approvals for additional indications, and addressing unmet medical needs in the treatment of retinal diseases.

Sources

1. Pfizer: Phase 3 Study Showed MACUGEN® Improved Vision Over Standard Of Care In Patients With Diabetic Macular Edema[1].
2. Astellas Pharma US, Inc.: News Room - News Releases - Astellas Pharma US, Inc.[2].
3. MarketsandMarkets: Age-related Macular Degeneration (AMD) Drugs Market[3].
4. Patented Medicine Prices Review Board: Report on New Patented Drugs - Macugen[4].
5. Pfizer: Pfizer Reports Fourth-Quarter and Full-Year 2008 Results and 2009 Financial Guidance[5].