PERFLUTREN - Generic Drug Details

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.

One supplier is listed for this compound.

Summary for PERFLUTREN

International Patents:	81
US Patents:	11
Tradenames:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	28
What excipients (inactive ingredients) are in PERFLUTREN?	PERFLUTREN excipients list
DailyMed Link:	PERFLUTREN at DailyMed

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

Constraining patent/regulatory exclusivity:

5,527,521

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.

Recent Clinical Trials for PERFLUTREN

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

Sponsor	Phase
Eindhoven University of Technology	PHASE3
Thomas Jefferson University	PHASE3
Eigen	PHASE3

See all PERFLUTREN clinical trials

Pharmacology for PERFLUTREN

Drug Class	Contrast Agent for Ultrasound Imaging
Mechanism of Action	Ultrasound Contrast Activity

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 RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	10,583,207
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	11,529,431
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	10,588,988
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes	11,266,750
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes	9,789,210
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	11,266,750
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	11,395,856		Y	Y

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	8,685,441
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001	6,033,645
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001	8,658,205
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001	5,527,521
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001	6,528,039
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001	9,545,457
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001	6,146,657

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
South Korea	20170098880
Japan	2023089124
European Patent Office	3452108
European Patent Office	4154915	COMPOSITIONS DE MICROSPHÈRES GAZEUSES ENROBÉES DE LIPIDES ET PROCÉDÉS CONNEXES (LIPID-ENCAPSULATED GAS MICROSPHERE COMPOSITIONS AND RELATED METHODS)
Israel	296875
Japan	2023089124	脂質カプセル化ガスマイクロスフェア組成物および関連方法 (LIPID-ENCAPSULATED GAS MICROSPHERE COMPOSITIONS AND RELATED METHODS)
Hong Kong	1244677	脂質封裝的氣體微球組合物及相關方法 (LIPID-ENCAPSULATED GAS MICROSPHERE COMPOSITIONS AND RELATED METHODS)

Supplementary Protection Certificates for PERFLUTREN

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

Market Dynamics and Financial Trajectory for Perflutren

Last updated: July 28, 2025

Introduction

Perflutren, marketed under brand names such as Definity, is a contrast dye used predominantly in diagnostic ultrasound imaging. Approved originally for enhancing echocardiography and peripheral vascular imaging, perflutren’s market landscape is shaped by regulatory developments, clinical demand, technological advancements, and competitive positioning. This report offers a comprehensive analysis of the current market dynamics and the financial prospects for perflutren, considering known industry trends, regulatory nuances, and emerging medical practices.

Regulatory Landscape and Market Access

The regulatory environment significantly influences perflutren’s market trajectory. In 2017, the U.S. Food and Drug Administration (FDA) approved Definity as a multiple-dose vial, simplifying administration protocols and expanding clinical utility. However, regulatory approvals vary across regions, with some markets displaying stringent restrictions due to safety concerns linked to adverse reactions such as hypersensitivity and anaphylaxis[1].

In recent years, regulatory agencies have prioritized safety profiles, prompting companies to invest in post-market surveillance and formulation improvements. For example, the renewed focus on adverse event data has led to updated labeling and warnings, which may influence prescribing practices and market penetration.

Furthermore, patent statuses critically impact competitive dynamics. While Definity enjoyed patent protection for several years, recent patent expirations, combined with the introduction of generic formulations, have intensified market competition, exerting downward pressure on pricing and margins.

Clinical Adoption and Demand Drivers

The demand for perflutren hinges on the expanding utilization of contrast-enhanced ultrasound (CEUS) in cardiology and vascular imaging. The advantages of CEUS, including lower cost, real-time imaging, absence of ionizing radiation, and safety profile, have spurred broader clinical adoption [2].

Key drivers include:

• Growing Prevalence of Cardiovascular Diseases (CVD): CVD remains the leading cause of mortality globally, fueling demand for accurate, non-invasive diagnostic tools, including contrast agents like perflutren[3].

• Ease of Use in Imaging Procedures: The development of user-friendly, multi-dose formulations has facilitated easier integration into routine workflows, promoting uptake among clinicians.

• Reimbursement Policies: In regions such as the U.S., favorable reimbursement for contrast-enhanced echocardiography incentivizes utilization. The Centers for Medicare & Medicaid Services (CMS) offers coverage for contrast imaging procedures, indirectly supporting sales[4].

However, safety concerns and competition from other contrast agents, such as sulfur hexafluoride-based agents, influence clinical preferences, potentially limiting market growth.

Technological and Competitive Landscape

Perflutren faces stiff competition from alternative contrast agents, including microbubble-based formulations like Lumason (SonoVue) and SonoVue’s competitors, offering differing safety and efficacy profiles [5].

Innovation within the industry includes developing second-generation contrast agents with improved stability, reduced adverse effects, and enhanced imaging capabilities. These technological advancements can threaten perflutren’s market share unless continuous reformulation and marketing efforts are maintained.

Moreover, advances in ultrasound imaging technology itself may reduce reliance on contrast agents in some indications by improving image quality, thereby affecting the demand for perflutren.

Market Size and Financial Trajectory

Current Market Valuation

Global demand for ultrasound contrast agents was valued at approximately $600 million in 2022, with perflutren accounting for a substantial segment owing to its early market presence and established clinical use. The U.S. remains the primary revenue generator, owing to high adoption rates, detailed reimbursement systems, and a large prevalence of cardiovascular disease.

Revenue Expectations and Growth Prospects

Projection models suggest a moderate compound annual growth rate (CAGR) of 3-5% for the global contrast agent market over the next five years, driven by increasing cardiovascular disease prevalence, technological advancements, and expanded indications, including hepatic and oncologic imaging [6].

Perflutren's revenue trajectory is expected to mirror these trends, although market saturation due to the proliferation of competing agents and generics might impose constraints on top-line growth.

Impact of Patent Expirations and Generics

Patent expirations over the last few years have introduced generic versions, exerting downward pressure on drug prices. Companies that have successfully transitioned from proprietary formulations to generic manufacturing have maintained profitability amid declining prices, often through cost efficiencies and market share consolidation.

Emerging Markets and Global Expansion

Emerging markets present opportunities due to rising healthcare investments and growing awareness of contrast-enhanced ultrasound modalities. Regulatory acceptance and price sensitivities in these regions can influence revenue streams, necessitating tailored strategies for global expansion.

Strategic Considerations and Future Outlook

To sustain market relevance, pharmaceutical companies focusing on perflutren must consider:

• Product Innovation: Developing next-generation contrast agents with enhanced safety and efficacy profiles.

• Regulatory Navigation: Ensuring compliance and expediting approvals to widen market access.

• Clinical Evidence Generation: Investing in large-scale studies to demonstrate comparative advantages over competitors.

• Diversification of Indications: Expanding into emerging imaging fields such as oncological and hepatic diagnostics to diversify revenue streams.

• Pricing and Reimbursement Strategies: Engaging with payers to secure favorable coverage and mitigate pricing pressures resultant from generics.

In light of these factors, the financial outlook for perflutren remains cautiously optimistic, conditional on technological innovation and strategic market positioning amidst growing competition and regulatory scrutiny.

Key Takeaways

• The perflutren market is primarily driven by the increasing adoption of contrast-enhanced ultrasound in cardiovascular diagnostics, supported by its safety and cost-effectiveness.

• Regulatory approvals and patent expirations significantly influence market access, pricing, and competition. Generics and new formulations are reshaping revenue dynamics.

• The global ultrasound contrast agent market is growing at a moderate pace, with opportunities in emerging markets and expanded clinical indications.

• Continuous innovation and favorable reimbursement policies are vital for maintaining market share and ensuring sustainable financial growth.

• Companies must navigate safety concerns, technological competition, and evolving clinical guidelines to succeed in this evolving landscape.

FAQs

1. What are the primary clinical applications of perflutren?
Perflutren’s primary uses include contrast-enhanced echocardiography for assessing cardiac function, detecting intracardiac shunts, and evaluating vascular perfusion, with expanding applications in hepatic and oncological imaging.

2. How do patent expirations impact perflutren’s market?
Patent expirations facilitate the entry of generic versions, leading to reduced pricing and margin pressure for brand-name manufacturers but also enabling broader access and increased volume sales.

3. What are the main safety concerns associated with perflutren?
Adverse reactions such as hypersensitivity and anaphylaxis have been reported, prompting regulatory warnings and influencing clinician prescribing behavior.

4. How does technological innovation influence perflutren’s competitiveness?
Advancements in ultrasound imaging and alternative contrast agents can reduce reliance on perflutren, underscoring the need for product innovation to maintain relevance.

5. What strategies can manufacturers adopt to sustain growth in this market?
Innovating safer and more effective formulations, expanding indications, navigating regulatory pathways efficiently, and engaging with payers for favorable reimbursement are key strategies.

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Sources

[1] FDA. (2017). FDA approves new ultrasound contrast agent.
[2] Saker, M., et al. (2021). Advances in contrast-enhanced ultrasound. Journal of Medical Imaging.
[3] World Health Organization. (2022). Cardiovascular disease epidemiology.
[4] Centers for Medicare & Medicaid Services. (2022). Coverage policies for contrast-enhanced ultrasound.
[5] MarketWatch. (2022). Contrast agents market analysis.
[6] Fortune Business Insights. (2022). Ultrasound contrast agent market size and growth forecasts.