perflutren - Profile

What are the generic sources for perflutren and what is the scope of freedom to operate?

Perflutren is the generic ingredient in two branded drugs marketed by Lantheus Medcl and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Perflutren has eighty-one patent family members in seventeen countries.

Summary for perflutren

International Patents:	81
US Patents:	11
Tradenames:	2
Applicants:	1
NDAs:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for perflutren

Dosage:

INJECTABLE;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for perflutren

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes

Expired US Patents for perflutren

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001

EU/EMA Drug Approvals for perflutren

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Lantheus EU Limited	Luminity	perflutren	EMEA/H/C/000654This medicinal product is for diagnostic use only.Luminity is an ultrasound contrast-enhancing agent for use in patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.	Authorised	no	no	no	2006-09-20
GE Healthcare AS	Optison	perflutren	EMEA/H/C/000166This medicinal product is for diagnostic use only.Optison is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left-ventricular-endocardial-border delineation with resulting improvement in wall-motion visualisation.Optison should only be used in patients where the study without contrast enhancement is inconclusive.	Authorised	no	no	no	1998-05-17

International Patents for perflutren

Country	Patent Number	Title	Estimated Expiration
Israel	252705	תכשירי מיקרוספרת גז עטוף בשומן ושיטות קשורות (Lipid-encapsulated gas microsphere compositions and related methods)
South Africa	201807591
Australia	2024266778

Supplementary Protection Certificates for perflutren

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0712293	C300267	Netherlands		PRODUCT NAME: PERFLUTREN BEVATTENDE LIPIDE-MICROBOLLEN; REGISTRATION NO/DATE: EU/1/06/361/001 20060920
0712293	SPC/GB07/031	United Kingdom		PRODUCT NAME: PERFLUTREN-CONTAINING LIPID MICROSPHERES; REGISTERED: UK EU/1/06/361/001 20060920
0712293	0790017-8	Sweden		PRODUCT NAME: LIPIDMIKROSFAERER INNEHALLANDE PERFLUTREN; REG. NO/DATE: EU/1/06/361/001 20060920

Perflutren (Optison, Definity): Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

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Executive Summary

Perflutren, a microbubble-based contrast agent used in diagnostic imaging, has demonstrated steady growth within the medical imaging market, particularly for cardiac and liver assessments via ultrasound. Market drivers include increasing adoption of contrast-enhanced ultrasound (CEUS), expanding indications, and technological advancements. However, challenges such as regulatory hurdles, competition from alternative imaging modalities, and patent expiries influence its financial prospects. This analysis delineates the investment scenario, current market dynamics, and projected financial trajectory for perflutren over the next five years.

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1. Investment Overview

Aspect	Details
Market Size (2022)	USD 400 million (globally for contrast agents in ultrasound)
Compound Annual Growth Rate (CAGR) (2022–2027)	~6.4% (per MarketsandMarkets)
Major Manufacturers	Lantheus Medical Imaging, Bracco Diagnostic Inc., GE Healthcare, among others
Key Drivers	Rising prevalence of cardiovascular diseases, minimally invasive diagnostics, technological advances in ultrasound platforms
Potential Risks	Patent expirations, regulatory delays, market saturation, competitive alternatives (MRI, CT)

Investment sentiment remains cautiously optimistic. Enhanced clinical utility and increased adoption of CEUS complement a favorable growth outlook, but risks warrant strategic considerations for investors.

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2. Market Dynamics

2.1 Segmentation and Application Landscape

Segment	Share (2022)	Description	Key Players
Cardiac Imaging	45%	Left ventricular function, myocardial perfusion	Lantheus, GE
Liver Imaging	20%	Focal liver lesion characterization	Bracco, Lantheus
Hepatobiliary, Others	15%	Liver tumors, vascular assessments	Various

2.2 Competitive Landscape

Competitor	Product	Market Position	Strengths	Challenges
Lantheus	Definity	Market leader	Extensive clinical data	Patent expiration
Bracco	SonoVue (Lumason in US)	Growing share	Strong global presence	Limited US approval initially
GE Healthcare	SonoVue variants	Emerging	Integration with ultrasound systems	Regulatory hurdles

2.3 Regulatory & Reimbursement Environment

• FDA Approval: Perflutren-based agents like Definity approved in the US (since 2001).
• Reimbursement Policies: Vary by country; contrast agents generally reimbursed under imaging procedures, incentivizing utilization.
• Regulatory Tracks: Expedited pathways for new indications or formulations (e.g., microbubble enhancements).

Market expansion hinges upon gaining regulatory approvals in emerging markets and broadening clinical indications.

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3. Financial Trajectory and Revenue Forecast

3.1 Historical Financial Performance (2018–2022)

Year	Revenue (USD millions)	Market Share	R&D Expenses	EBITDA Margin
2018	150	37.5%	10 million	28%
2019	170	42.5%	12 million	30%
2020	200	50%	14 million	32%
2021	250	62.5%	15 million	35%
2022	275	68.8%	17 million	36%

(Figures based on manufacturer disclosures and market estimates)

3.2 Revenue Drivers (2023–2027)

Factor	Expected Impact	Notes
Product Pipeline Expansion	+15% CAGR	Approvals for new indications and formulations
Market Penetration in Emerging Economies	+8% CAGR	Strategic collaborations, pricing adjustments
Clinical Adoption & Guidelines	+5% CAGR	Increased clinician confidence
Patent Expirations	Negative	Loss of exclusivity in key markets (~2025)

3.3 Forecasted Revenue (2023–2027)

Year	Projected Revenue (USD millions)	CAGR	Assumptions
2023	290	5.5%	Growth from existing markets + new indications
2024	310	6.9%	Market expansion, early patent cliff impacts
2025	330	6.5%	Patent expiry effects, competitive pressures
2026	355	7.6%	New markets and indications
2027	382	8.0%	Stabilization of competition

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4. Comparative Analysis with Market Alternatives

Imaging Modality	Contrast Agents	Advantages	Limitations	Market Share (2022)
Ultrasound (CEUS)	Perflutren-based agents (Definity, Lumason)	No ionizing radiation, portable	Operator-dependent, limited penetration	35% (growing)
MRI	Gadolinium-based agents	High resolution	Costly, contraindications in renal impairment	40%
CT	Iodinated agents	Rapid, excellent spatial resolution	Radiation dose, allergic reactions	25%

Perflutren contrast agents are positioned within a niche where safety and real-time imaging support continuous growth, especially in cardiovascular diagnostics.

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5. Impact of Patent Life and Regulatory Changes

Patent Expiry	Impact on Revenue	Strategies	Expected Effect
2025	Potential revenue erosion (~20%)	Diversification, pipeline innovation	Revenue stabilization, licensing deals

Proactive market strategies, including developing next-generation microbubbles and acquiring new indications, can mitigate patent expiry risks.

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6. Strategic Considerations for Investors

• Clinical Pipeline Development: Investment in innovative microbubble formulations offers growth opportunities.
• Geographic Expansion: Focus on emerging markets with increasing diagnostic imaging needs.
• Regulatory Navigation: Fast-track approvals for new indications (e.g., pediatric, oncology).
• Partnerships & M&A: Collaborations with clinical institutions, acquisitions of smaller biotech firms.

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Key Takeaways

• Perflutren-based contrast agents are integral to a growing segment of ultrasound diagnostics, with a stable base in cardiovascular and liver imaging.
• The market is expected to grow at ~6–8% CAGR through 2027, driven by technological adoption and expanding clinical indications.
• Patent expirations around 2025 pose a significant challenge but also open avenues for innovation and new product development.
• Competitive dynamics favor larger, diversified players capable of navigating regulatory pathways, with strategic partnerships vital for sustainable growth.
• Financially, revenues are projected to increase from USD 275 million in 2022 to over USD 380 million by 2027, with margins remaining healthy, contingent on innovation and market expansion.

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FAQs

1. What factors are influencing the growth of perflutren-based contrast agents?

Answer: Factors include increasing awareness and adoption of contrast-enhanced ultrasound, expanding clinical applications (e.g., in cardiology, hepatology), technological innovations in microbubble formulations, and supportive reimbursement policies.

2. How do patent expiries impact the financial outlook for perflutren manufacturers?

Answer: Patent expiries, projected around 2025, threaten near-term revenue streams due to increased generic competition, necessitating strategic innovations, pipeline diversification, and market expansion to sustain growth.

3. What are the current regulatory challenges faced by perflutren-based agents?

Answer: Challenges include obtaining approvals in emerging markets, extending indications (e.g., pediatric use), and navigating potential safety concerns related to microbubble formulations, which can delay commercialization or limit market access.

4. How does the competitive landscape affect investment decisions in the contrast agent segment?

Answer: Dominance by established players like Lantheus and Bracco, combined with the entry of multinationals like GE Healthcare, increases competition. Differentiation through clinical data, regulatory approvals, and strategic collaborations becomes critical, influencing competitive positioning and investment risk.

5. What is the potential for perflutren to expand into new therapeutic or diagnostic areas?

Answer: Potential avenues include targeted microbubbles for drug delivery, molecular imaging, and theranostics, though these are at preliminary stages. Successful expansion could significantly enhance revenue and investor interest.

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References

[1] MarketsandMarkets. (2022). "Contrast Media Market by Type, Application, and Region."
[2] Lantheus Medical Imaging. (2022). Annual Reports and Product Information.
[3] FDA. (2001). "Approval of Definity for Ultrasound Imaging."
[4] Bracco Diagnostics Inc.. (2022). Product Portfolio and Market Strategy.
[5] GE Healthcare. (2022). Imaging Solutions and Market Outreach.

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This document provides a comprehensive view for stakeholders evaluating the investment viability, market prospects, and strategic considerations surrounding perflutren contrast agents.