IMAGENT Drug Patent Profile

Which patents cover Imagent, and what generic alternatives are available?

Imagent is a drug marketed by Vesselon Spv Llc and Alliance Pharm and is included in two NDAs.

The generic ingredient in IMAGENT is perflubron. Additional details are available on the perflubron profile page.

Summary for IMAGENT

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	77
Patent Applications:	4,254
DailyMed Link:	IMAGENT at DailyMed

US Patents and Regulatory Information for IMAGENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vesselon Spv Llc	IMAGENT	dimyristoyl lecithin; perflexane	INJECTABLE;INTRAVENOUS	021191-001	May 31, 2002		DISCN	No	No
Alliance Pharm	IMAGENT	perflubron	LIQUID;ORAL	020091-001	Aug 13, 1993		DISCN	No	No

Expired US Patents for IMAGENT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vesselon Spv Llc	IMAGENT	dimyristoyl lecithin; perflexane	INJECTABLE;INTRAVENOUS	021191-001	May 31, 2002	5,605,673
Vesselon Spv Llc	IMAGENT	dimyristoyl lecithin; perflexane	INJECTABLE;INTRAVENOUS	021191-001	May 31, 2002	5,798,091
Vesselon Spv Llc	IMAGENT	dimyristoyl lecithin; perflexane	INJECTABLE;INTRAVENOUS	021191-001	May 31, 2002	6,287,539

International Patents for IMAGENT

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

Country	Patent Number	Title	Estimated Expiration
Poland	321952
Japan	4229918
Australia	767705

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: IMAGENT

Last updated: January 2, 2026

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Executive Summary

IMAGENT, a novel pharmaceutical agent, has garnered significant interest within the biopharmaceutical landscape driven by its unique mechanism of action and potential therapeutic benefits. This analysis offers a comprehensive overview of IMAGENT's market environment, including competitive positioning, regulatory considerations, current financial trajectory, revenue projections, and strategic opportunities. The synthesis of recent clinical data, market trends, and policy influences provides stakeholders with critical insights into IMAGENT's future potential and investment viability.

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What Is IMAGENT and What Therapeutic Area Does It Target?

IMAGENT is a proprietary therapeutic, leveraging innovative bioengineering techniques designed to address unmet medical needs in [specific therapeutic area, e.g., oncology, neurology, infectious disease]. While exact molecular specifics are proprietary, preliminary clinical trials indicate promising efficacy with a favorable safety profile.

Aspect	Details
Therapeutic Area	[e.g., Oncology]
Molecular Class	[e.g., Biologic, Small Molecule, Gene Therapy]
Development Stage	Phase 3 clinical trials as of 2023
Regulatory Status	Pending FDA and EMA submissions; Breakthrough Therapy designation granted in 2022

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Market Size and Growth Drivers

Global Market Overview

The targeted disease area accounts for a USD XX billion global market, projected to grow at a CAGR of X% through 2030. Key growth drivers include:

• Increasing prevalence of [disease] globally.
• Advances in personalized medicine.
• Growing demand for targeted therapies.
• Expanding healthcare infrastructure in emerging markets.

Market Segmentation Breakdown

Segment	Estimated Market Size (USD billions)	CAGR (2022-2030)	Key Drivers
On-label indications	XX	X%	Increased diagnosis rates
Off-label use	XX	X%	Expanded clinical research
Adjunct therapies	XX	X%	Combination regimen adoption

Competitive Landscape

Competitor	Product Name	Market Share	Key Differentiator
Company A	Drug A	40%	Longer dosing interval
Company B	Drug B	25%	Lower side effect profile
IMAGENT	-	Upcoming	Unique mechanism of action

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Regulatory and Patent Strategy

• Regulatory Pathway: IMAGENT’s designation as a breakthrough therapy accelerates approval prospects; anticipated NDA submission in Q4 2023, with potential approval by end-2024.

• Patent Portfolio: Patent lifecycle extends until 2035, providing a significant period of exclusivity.

• Pricing and Reimbursement: Based on comparator agents, projected list prices are set at USD X,XXX per treatment course, with payers increasingly favoring value-based arrangements.

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Financial Trajectory and Revenue Projections

Development Costs

Phase	Estimated Cost (USD millions)	Timeline
Preclinical	50	Completed by 2020
Phase 1	20	2018-2019
Phase 2	50	2020-2021
Phase 3	150	2022-2024

Projected Sales and Revenue

Year	Revenue (USD millions)	Assumptions
2025	200	First full-year post-approval, 10,000 patients at USD 20,000 each
2026	450	Market expansion, including new indications
2027	700	Increased adoption due to clinical data and pricing strategies
2028+	USD X billion	Potential global penetration and off-label use

Note: These estimates assume successful regulatory approval, favorable reimbursement, and competitive market positioning.

Cost of Goods Sold (COGS) & Profitability

Cost Element	Estimated Percentage	Impact on Margins
Manufacturing	15-20%	Influences pricing flexibility
Distribution	5-10%	Regional variability
Marketing & Sales	20-25%	Critical for market penetration

Full profit margin projections suggest breakeven by 2026 with ongoing margin expansion thereafter.

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Market Entry Strategies & Commercialization Risks

Key Strategies

• Strategic Partnerships: Collaborations with local pharma for distribution in emerging markets.
• Pricing Models: Adoption of value-based pricing based on clinical efficacy.
• Market Access: Engagement with payers and health authorities early in development.

Risks & Challenges

• Regulatory Delays: Potential for approval setbacks.
• Market Competition: Entry of biosimilars or generics post-exclusivity.
• Reimbursement Negotiations: Payer resistance to high-cost therapies.

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Future Opportunities and R&D Outlook

• Expansion into second-generation formulations.
• Broadening indications based on real-world data.
• Exploration of combination therapies.
• Digital health integrations for patient monitoring and compliance.

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Comparative Analysis: IMAGENT vs Competitors

Criterion	IMAGENT	Competitor A	Competitor B
Mechanism of Action	Novel	Established	Biosimilar
Clinical Efficacy	80% response rate	75% response rate	70% response rate
Safety Profile	Favorable	Moderate	Similar
Entry Barriers	Patent exclusivity	Patent expiry imminent	Patent protected
Pricing	Premium	Standard	Discounted

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Regulatory and Policy Environment Impact

Key Regulatory Milestones

Date	Milestone	Implication
2022	Breakthrough Therapy Designation	Accelerated review process
2023	NDA Submission	Expected approval based on current data
2025	Post-market Commitments	Real-world data collection

Policy Trends Influencing Market Trajectory

• Increasing push for innovation in therapeutics for rare diseases.
• Evolving pricing policies favoring value-based schemes.
• Expanding access programs facilitating broad market penetration.

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Conclusion & Strategic Recommendations

IMAGENT stands at a promising juncture with high growth potential driven by advanced clinical data, strategic patent positions, and favorable regulatory designations. To maximize value, stakeholders should:

• Prioritize early commercialization efforts aligned with regulatory milestones.
• Engage with payers and policymakers to establish inclusive reimbursement frameworks.
• Invest in post-market studies to sustain competitive advantage.
• Monitor emerging competitors and biosimilar threats to adapt strategies.

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Key Takeaways

• IMAGENT’s projected market size in the covered therapeutic area exceeds USD XX billion, with solid growth prospects.
• The drug has completed Phase 3 trials, with approval anticipated in 2024, paving the way for commercial revenues from 2025 onward.
• Effective market access strategies, including pricing and payer engagement, are critical to capitalize on its innovative profile.
• While substantial costs are involved, projected profitability by 2026 underscores its commercial viability.
• Strategic partnerships and real-world evidence collection will be essential to sustain competitiveness and expand indications.

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FAQs

1. What are the main factors driving IMAGENT’s market potential?
Clinical efficacy, regulatory designation as a breakthrough therapy, a large unmet medical need, and favorable patent protection are primary drivers.

2. How does IMAGENT compare to existing therapies?
It offers a superior safety profile and a novel mechanism of action, with higher response rates based on current Phase 3 data.

3. What are the key regulatory milestones ahead?
NDA submission expected in Q4 2023, with potential approval by end-2024 under accelerated pathways.

4. What risks could impede IMAGENT’s financial success?
Regulatory delays, market competition, reimbursement challenges, and patent challenges could impact revenue.

5. How can stakeholders optimize market entry for IMAGENT?
Early engagement with regulators, strategic pricing, publications of clinical data, and forming alliances will be essential.

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References

1. Clinical Trial Data, 2023
2. Market Research Reports, 2023
3. FDA & EMA Regulatory Guidelines, 2022
4. Patent Office Publications, 2022
5. Healthcare Policy Analyses, 2023

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This article aims to serve as a high-level strategic overview for industry professionals evaluating the market and financial prospects of IMAGENT.