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

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
GE Healthcare	PHASE3
Amsterdam UMC, location VUmc	PHASE3
Eindhoven University of Technology	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
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 RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		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
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
Japan	2020172507	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)
Taiwan	201815424
Canada	3025580	PROCEDES DE PRODUCTION D'AGENTS DE CONTRASTE D'ULTRASONS (METHODS FOR MAKING ULTRASOUND CONTRAST AGENTS)
Mexico	2022011694
South Africa	201807871
Japan	7316793

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	0790017-8	Sweden		PRODUCT NAME: LIPIDMIKROSFAERER INNEHALLANDE PERFLUTREN; REG. NO/DATE: EU/1/06/361/001 20060920
0712293	C300267	Netherlands		PRODUCT NAME: PERFLUTREN BEVATTENDE LIPIDE-MICROBOLLEN; REGISTRATION NO/DATE: EU/1/06/361/001 20060920

Perflutren: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Overview of Perflutren Market Landscape

Perflutren, a contrast agent primarily utilized in medical imaging, has established a stable market presence. Its efficacy in enhancing ultrasound visualization of blood flow, particularly in cardiac and abdominal applications, underpins its consistent demand. The market is characterized by a limited number of key manufacturers and a mature regulatory environment. Competition exists from alternative contrast agents and imaging modalities, but perflutren's established safety profile and specific application advantages maintain its market share. Future market growth is projected to be moderate, driven by an aging global population, increasing prevalence of cardiovascular diseases, and advancements in ultrasound technology.

Key Applications and Clinical Utility

Perflutren's primary clinical utility centers on its role as an ultrasound contrast agent. It is administered intravenously to improve the visualization of blood flow and tissue perfusion during diagnostic ultrasound procedures.

• Cardiology: Perflutren is frequently used in myocardial contrast echocardiography (MCE) to assess myocardial perfusion. This application helps identify areas of ischemia or infarction in patients with suspected or known coronary artery disease. It aids in the assessment of microvascular function and can guide therapeutic interventions.
• Hepatology and Nephrology: In abdominal imaging, perflutren enhances the detection and characterization of liver lesions, including tumors and cysts. It also improves the visualization of renal vasculature, assisting in the diagnosis of conditions such as renal artery stenosis.
• Other Applications: Perflutren finds use in evaluating blood flow in other organs, such as the spleen and pancreas, and in certain gynecological and urological imaging scenarios.

The agent's ability to provide real-time, dynamic imaging of blood flow is a critical factor in its clinical adoption.

Manufacturing and Supply Chain

The manufacturing of perflutren involves specialized chemical synthesis and formulation processes. Perflutren itself is a perfluorocarbon, requiring stringent quality control measures to ensure purity and safety.

Key manufacturing considerations include:

• Active Pharmaceutical Ingredient (API) Synthesis: The production of perflutren gas involves complex fluorination chemistry. This requires specialized facilities and expertise to handle the reactive chemicals involved.
• Formulation: Perflutren is typically supplied as a liquid suspension or an injectable solution. The formulation process involves stabilizing the perflutren microbubbles within a biocompatible carrier, often an aqueous solution. This requires precise control of particle size and distribution to optimize echogenicity and safety.
• Sterilization and Packaging: As an injectable product, perflutren undergoes rigorous sterilization processes to meet pharmaceutical standards. Packaging is designed to maintain sterility and product integrity during storage and transport.
• Regulatory Compliance: Manufacturing facilities and processes must adhere to Good Manufacturing Practices (GMP) as mandated by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The supply chain for perflutren involves sourcing raw materials, API manufacturing, formulation, packaging, distribution to healthcare providers, and ultimately administration to patients. Disruptions in any part of this chain, particularly in the availability of specialized raw materials or manufacturing capacity, could impact market supply.

Regulatory Landscape and Patent Expirations

The regulatory pathway for perflutren has been established through approvals by major health authorities. Its status as a medical device or drug product depends on its specific formulation and intended use, influencing the regulatory oversight.

• FDA Approval: Products containing perflutren have undergone rigorous review by the FDA, including preclinical and clinical trials to demonstrate safety and efficacy for specific indications. For example, Lumason® (a perflutren lipid microsphere ultrasound contrast agent) received FDA approval for certain cardiac and abdominal imaging applications [1].
• EMA Approval: Similar approval processes exist within the European Union through the EMA, leading to market authorization in member states.
• Patent Status: Patents protecting perflutren formulations and their manufacturing processes are critical to the financial trajectory of the originating companies. Key patents related to perflutren technology have expired or are nearing expiration in major markets. For instance, patents covering earlier generations of perflutren-based contrast agents have expired, opening avenues for generic competition. The expiry of a patent typically leads to the introduction of biosimilar or generic versions, increasing competition and potentially reducing market prices.

The interplay between regulatory hurdles for new entrants and the expiration of existing patents defines the competitive landscape and influences pricing dynamics.

Market Size and Revenue Projections

The global market for ultrasound contrast agents, including perflutren, is a segment within the broader medical imaging market. Accurate market size figures for perflutren specifically can be challenging to isolate due to proprietary reporting and the classification of some agents. However, industry analysis provides insights into the broader market.

The global ultrasound contrast agents market was valued at approximately USD 500 million to USD 700 million in recent years. Projections indicate a compound annual growth rate (CAGR) of 4% to 7% for this market over the next five to seven years, driven by factors such as:

• Increasing Diagnostic Imaging Volume: A rising number of diagnostic ultrasound procedures globally.
• Cardiovascular Disease Prevalence: The growing burden of heart disease necessitates advanced diagnostic tools.
• Technological Advancements: Improved ultrasound equipment and new applications for contrast agents.
• Emerging Markets: Increased adoption of advanced medical technologies in developing economies.

Within this market, perflutren-based products contribute a significant portion, particularly in specialized cardiac and abdominal applications where their performance characteristics are well-established. The financial trajectory for perflutren will be influenced by the success of branded products and the eventual market entry of generic alternatives.

Competitive Landscape and Key Players

The market for perflutren-based contrast agents is characterized by a concentrated group of manufacturers, alongside a growing presence of generic competitors as patents expire.

Key players include:

• Branded Manufacturers:
  • GE HealthCare: Offers perflutren-based contrast agents, such as Lumason® (formerly Sonovue®) [1].
  • Other Pharmaceutical Companies: Various companies hold patents and market rights for perflutren formulations or related technologies. Specific market share data can fluctuate based on regional approvals and marketing strategies.
• Generic Manufacturers: With patent expirations, companies specializing in generic pharmaceuticals are entering or preparing to enter the market. This introduces price competition and increases the accessibility of perflutren-based agents.
• Competitors in Contrast Agents:
  • Sonazoid® (perflubutane): Another ultrasound contrast agent used primarily for liver lesion characterization.
  • Definity® (perflutren lipid microspheres): A well-established perflutren-based contrast agent.
  • Other Ultrasound Contrast Agents: Various other formulations and technologies exist, offering different pharmacokinetic profiles and clinical indications.
• Alternative Imaging Modalities: While not direct competitors in all applications, MRI and CT scans with their respective contrast agents represent alternative diagnostic pathways that may be considered depending on the clinical scenario.

The competitive intensity is expected to increase as more perflutren formulations come off patent, forcing branded manufacturers to focus on differentiation through services, ongoing clinical research, and life-cycle management.

Pricing and Reimbursement Dynamics

Pricing for perflutren-based contrast agents is influenced by several factors, including manufacturing costs, research and development investments, regulatory approval expenses, market exclusivity periods, and competitive pressures.

• Branded Product Pricing: Initially, branded perflutren products command premium pricing due to patent protection and the substantial investments made in clinical trials and regulatory submissions. Prices can range from hundreds to over a thousand dollars per dose, depending on the product and geographic market.
• Generic Erosion: Upon patent expiration, the introduction of generic alternatives typically leads to a significant decrease in pricing, often by 50% or more. This erosion is a standard market dynamic in the pharmaceutical industry.
• Reimbursement Policies: Healthcare systems and private insurers play a crucial role in reimbursement. The availability and level of reimbursement for perflutren contrast agents influence their uptake by healthcare providers. Coding and billing procedures, as well as payer coverage policies, directly impact the net revenue received by manufacturers and providers.
• Health Technology Assessments (HTAs): In some regions, HTAs are used to evaluate the cost-effectiveness of medical technologies, which can influence pricing and reimbursement decisions.

The financial trajectory of perflutren products will see an initial period of high revenue generation followed by a decline as generic competition intensifies.

Financial Performance and Investment Outlook

The financial performance of companies involved with perflutren is tied to the product lifecycle of its various formulations.

• Revenue Streams: Revenue is generated through direct sales of perflutren-based contrast agents to hospitals, clinics, and imaging centers. Licensing agreements for patent usage or technology transfer can also represent revenue streams.
• Profit Margins: Branded perflutren products typically enjoy higher profit margins during their exclusivity periods. Post-patent expiry, margins for both branded and generic products are expected to compress due to price competition.
• R&D Investment: Ongoing investment in R&D is necessary to develop next-generation contrast agents, explore new clinical applications, and defend market position through product line extensions or improved formulations.
• Investment Considerations: Investors evaluate companies based on their patent portfolios, market share in key indications, the strength of their R&D pipeline, and their ability to navigate the evolving regulatory and competitive landscape. Companies with diversified portfolios that include perflutren alongside other innovative products may offer more stable investment profiles. The decline in revenue from mature perflutren products due to patent expiry needs to be offset by growth in other areas.

The financial outlook for perflutren is one of mature market performance with declining revenue potential in established markets as exclusivity wanes, balanced by continued demand in specific clinical niches and potential growth in emerging markets.

Future Trends and Innovations

The future of perflutren and ultrasound contrast agents is shaped by ongoing research and technological advancements.

• New Formulations and Delivery Systems: Research continues into developing perflutren formulations with improved stability, longer circulation times, or enhanced targeting capabilities. This could involve novel lipid shell compositions or unique microbubble designs.
• Expanded Clinical Indications: Efforts are underway to expand the approved clinical uses of perflutren-based agents. This may include applications in areas beyond cardiology and abdominal imaging, such as interventional procedures or novel diagnostic paradigms.
• Personalized Medicine: As imaging techniques become more sophisticated, there is a push towards personalized medicine. This could involve tailoring contrast agent administration based on patient characteristics or specific disease biomarkers.
• Combination Therapies: The integration of ultrasound contrast agents with other therapeutic modalities, such as microbubble-mediated drug delivery or sonothrombolysis, represents a significant area of future innovation.
• Artificial Intelligence (AI) in Imaging: AI algorithms are increasingly being used to enhance image interpretation and automate analysis. This could lead to more efficient and accurate use of perflutren in diagnostic workflows.
• Sustainability in Manufacturing: As with all pharmaceuticals, there is growing attention to sustainable manufacturing practices, including reducing waste and energy consumption in the production of perflutren.

These trends suggest a market that, while mature for existing perflutren products, will continue to evolve through innovation in its application and formulation.

Key Takeaways

• Perflutren-based ultrasound contrast agents have a well-established clinical role, particularly in cardiology and abdominal imaging.
• The market is characterized by moderate growth, driven by aging populations and increasing disease prevalence.
• Patent expirations are leading to increased generic competition and pricing pressure.
• Key players include branded manufacturers like GE HealthCare and a growing number of generic competitors.
• Future innovation will focus on new formulations, expanded clinical indications, and integration with advanced technologies like AI.

FAQs

1. What is the primary mechanism of action for perflutren as an ultrasound contrast agent? Perflutren is administered intravenously as microbubbles that reflect ultrasound waves more strongly than blood, thereby enhancing the visualization of blood flow and tissue perfusion in ultrasound imaging.
2. Which medical specialties most commonly utilize perflutren? Cardiology and hepatology/nephrology are the primary medical specialties that utilize perflutren for diagnostic imaging of myocardial perfusion and abdominal organ vascularity, respectively.
3. How do patent expirations impact the market for perflutren? Patent expirations allow for the introduction of generic versions of perflutren-based contrast agents, which typically leads to significant price reductions and increased market competition.
4. What are the major challenges facing the perflutren market? Key challenges include the commoditization of older perflutren formulations due to patent expiry, competition from alternative contrast agents and imaging modalities, and the ongoing need for regulatory compliance and clinical validation of new applications.
5. Are there ongoing research efforts to develop new perflutren-based products? Yes, research is actively exploring novel perflutren formulations with improved stability and enhanced targeting capabilities, as well as investigating new clinical applications beyond current standard uses.

Citations

[1] U.S. Food & Drug Administration. (2023). Drug Shortages. Retrieved from https://www.fda.gov/drugs/drug-shortages (Note: While a general link, FDA's Drug Shortages database is a primary source for product-specific information when available, and specific product recalls or approvals are listed on their respective pages. Lumason® approval is publicly available through FDA's Orange Book and press releases.)