DEFINITY RT Drug Patent Profile

When do Definity Rt patents expire, and when can generic versions of Definity Rt launch?

Definity Rt is a drug marketed by Lantheus Medcl and is included in one NDA. There are eleven patents protecting this drug.

This drug has eighty-one patent family members in seventeen countries.

The generic ingredient in DEFINITY RT is perflutren. One supplier is listed for this compound. Additional details are available on the perflutren profile page.

DrugPatentWatch^® Generic Entry Outlook for Definity Rt

Definity Rt was eligible for patent challenges on July 31, 2005.

Indicators of Generic Entry

Summary for DEFINITY RT

International Patents:	81
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	69
Drug Prices:	Drug price information for DEFINITY RT
What excipients (inactive ingredients) are in DEFINITY RT?	DEFINITY RT excipients list
DailyMed Link:	DEFINITY RT at DailyMed

See drug prices for DEFINITY RT

Recent Clinical Trials for DEFINITY RT

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

Sponsor	Phase
Thomas Jefferson University	PHASE3
Eigen	PHASE3
GE Healthcare	PHASE3

See all DEFINITY RT clinical trials

Pharmacology for DEFINITY RT

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

US Patents and Regulatory Information for DEFINITY RT

DEFINITY RT is protected by eleven US patents.

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 RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes			Y	Y
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes

EU/EMA Drug Approvals for DEFINITY RT

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 DEFINITY RT

See the table below for patents covering DEFINITY RT around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9428873
Russian Federation	2181998	NOVEL COMPOSITIONS OF LIPIDS AND STABILIZING MATERIALS
China	1180310
Australia	2022201065	LIPID-ENCAPSULATED GAS MICROSPHERE COMPOSITIONS AND RELATED METHODS
Japan	2000510108

Supplementary Protection Certificates for DEFINITY RT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0712293	300267	Netherlands		300267, 20140520, EXPIRES: 20190519
0712293	SPC018/2007	Ireland		SPC018/2007: 20071012, EXPIRES: 20190519
0712293	0790017-8	Sweden		PRODUCT NAME: LIPIDMIKROSFAERER INNEHALLANDE PERFLUTREN; REG. NO/DATE: EU/1/06/361/001 20060920
0712293	CA 2007 00027	Denmark
0712293	C300267	Netherlands		PRODUCT NAME: PERFLUTREN BEVATTENDE LIPIDE-MICROBOLLEN; REGISTRATION NO/DATE: EU/1/06/361/001 20060920

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DEFINITY RT

Last updated: July 27, 2025

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Introduction

DEFINITY RT, a flagship echocardiography contrast agent, plays a pivotal role in enhancing diagnostic capabilities for cardiovascular imaging. Market dynamics underpin the drug’s adoption, revenue streams, regulatory environment, and competitive positioning, all of which shape its financial trajectory. Analyzing these factors offers critical insights for investors, healthcare providers, and pharmaceutical firms contemplating strategic decisions around this specialized product.

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Overview of DEFINITY RT

DEFINITY RT (perflutren lipid microsphere) is a second-generation ultrasound contrast agent approved primarily for enhancing myocardial and intracardiac imaging. It provides superior acoustic signal contrast, improving the detection of cardiac abnormalities, particularly in echocardiography. Its innovative formulation ensures better stability and safety profiles relative to earlier contrast agents, bolstering its clinical utility.

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Market Dynamics

1. Growing Demand for Advanced Cardiac Imaging

The expanding prevalence of cardiovascular diseases (CVD)—the leading cause of mortality globally—drives the uptake of enhanced diagnostic tools like DEFINITY RT. According to the World Health Organization, ischemic heart disease and stroke collectively cause over 17 million deaths annually, creating a persistent need for precise, non-invasive diagnostic modalities. Advanced biochemistry and imaging technology advances, coupled with broader clinical acceptance of contrast-enhanced echocardiography, amplify demand for products such as DEFINITY RT.

2. Regulatory Approvals and Market Expansion

Initially approved by the U.S. FDA in 2011, DEFINITY RT has secured regulatory clearances across several key markets, including Europe and Asia-Pacific. Continued approvals facilitate geographic expansion, notably into emerging economies where rising healthcare infrastructure investments heighten the adoption of state-of-the-art diagnostic agents. Regulatory pathways influence market penetration and revenue potential, with approvals often contingent on demonstrating safety, efficacy, and compatibility with existing imaging modalities.

3. Competitive landscape

The contrast agent market is characterized by a handful of entrenched competitors, notably Lumason and SonoVue, alongside emerging generics and next-generation agents. DEFINITY RT benefits from a robust clinical evidence base, favored safety profile, and longstanding clinician familiarity. However, competition is fierce, with innovators exploring alternatives like microbubble formulations and targeted contrast agents, potentially impacting market share over the long term.

4. Insurance Coverage and Reimbursement Policies

Reimbursement frameworks significantly influence the uptake of contrast agents. Historically, insurance payers in the US and Europe have provided coverage for contrast-enhanced echocardiography, but reimbursement levels and policies vary regionally and can fluctuate with evolving clinical guidelines. Favorable reimbursement models bolster customer adoption, directly affecting sales volume and revenue streams for DEFINITY RT.

5. Clinical Guidelines and Adoption Trends

The integration of DEFINITY RT into standard cardiology practice hinges on endorsement by professional bodies such as the American Society of Echocardiography (ASE). Recent guideline updates endorse contrast-enhanced echocardiography for specific indications, fostering increased clinician confidence and utilization. Education initiatives and clinical trial data further bolster adoption, directly influencing product sales.

6. Technological Integration and Market Consolidation

Integration with advanced ultrasound systems and interoperability with electronic health records (EHR) streamline clinical workflows, making contrast agents more attractive for routine use. Market consolidation, through mergers and acquisitions among diagnostic imaging companies and contrast manufacturers, could influence supply chains, pricing strategies, and innovation pace.

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Financial Trajectory Predictions

1. Revenue Growth Trends

The growth trajectory of DEFINITY RT hinges on several factors: rising global CVD prevalence, expanding indications, and market acceptance. Analysts project a compound annual growth rate (CAGR) of approximately 4-6% over the next five years within the contrast agent segment, driven by increased procedural volume and diagnostic refinement.

2. Impact of Market Penetration

In mature markets like the US and Europe, sales growth may plateau as penetration approaches saturation. Conversely, developing regions represent significant upside potential due to burgeoning healthcare infrastructure and rising awareness. Targeted marketing efforts and strategic partnerships with regional healthcare providers can accelerate revenue expansion in these markets.

3. Pricing Strategies

Pricing models impact the financial trajectory, balancing profitability and market accessibility. Premium positioning leverages DEFINITY RT's clinical efficacy, but pricing pressures from competitors and payers necessitate value-based strategies. Bundling contrast agent sales with ultrasound systems or service contracts can enhance margins.

4. R&D and Pipeline Developments

Investment in research to broaden indications—such as for microvascular or molecular imaging—could create new revenue streams. Early-stage pipeline products or next-generation contrast formulations might command premium pricing if they demonstrate enhanced safety, efficacy, or ease of use.

5. Regulatory Landscape as a Financial Catalyst or Barrier

Timely approvals and favorable regulatory decisions underpin confidence and immediate revenue forecasts. Conversely, delays or adverse rulings could freeze or diminish sales prospects, emphasizing the importance of proactive regulatory engagement.

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Long-Term Market Outlook

The healthcare industry’s focus on precision diagnostics, minimally invasive procedures, and personalized medicine supports sustained demand for agents like DEFINITY RT. Market forecasts indicate modest, steady growth, influenced by technological innovation, healthcare policy shifts, and demographic trends. However, emerging competitors and evolving clinical practices pose moderate risks to the established financial trajectory.

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Key Factors Influencing Future Financial Performance

• Global epidemiological trends: Rising CVD cases globally drive demand.
• Regulatory environment: Approval timelines and policy shifts directly impact market access.
• Technological advancements: Improved ultrasound systems facilitate contrast agent utilization.
• Competitive pressures: Market share depends on differentiation, safety profile, and clinical endorsement.
• Reimbursement policies: Sustainability hinges on payer acceptance and coverage stability.

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Key Takeaways

• Market expansion prospects are robust, especially in emerging economies where increasing healthcare infrastructure and awareness are vital factors.
• Regulatory approvals remain critical; proactive engagement and compliance reduce delays, securing revenue streams.
• Competitive positioning requires ongoing clinical evidence, technological integration, and strategic pricing to maintain and grow market share.
• Reimbursement frameworks heavily influence adoption; advocacy and economic evaluations are essential for securing favorable policies.
• Innovation pipeline investments can unlock new revenue opportunities, offset market saturation in mature regions.

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FAQs

Q1: What clinical advantages does DEFINITY RT offer over traditional echocardiography?
DEFINITY RT significantly improves image clarity, enhancing the detection of cardiac abnormalities, which leads to more accurate diagnoses and optimal patient management.

Q2: How does the regulatory environment impact DEFINITY RT's market potential?
Regulatory approvals in key markets are essential for market entry and revenue generation. Delays or restrictions can hinder growth, while approvals expand customer access and clinical adoption.

Q3: What competitive threats could affect DEFINITY RT’s market share?
Emerging contrast agents with improved safety, efficacy, or cost advantages, along with aggressive marketing by competitors, pose risks to DEFINITY RT’s dominance.

Q4: How do reimbursement policies influence the financial trajectory of DEFINITY RT?
Reimbursement coverage determines clinical uptake; favorable policies facilitate higher utilization, while reimbursement challenges can constrain sales.

Q5: What strategies can maximize DEFINITY RT’s market potential in the coming years?
Focus on expanding clinical evidence, forging regional partnerships, integrating with advanced ultrasound systems, and advocating for favorable reimbursement policies will enhance growth.

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Sources:
[1] World Health Organization. Cardiovascular Diseases Fact Sheet. 2021.
[2] U.S. Food and Drug Administration. DEFINITY (perflutren lipid microsphere) approval documents. 2011.
[3] Market research reports on contrast agents and cardiovascular imaging trends, 2022.
[4] American Society of Echocardiography Clinical Guidelines, 2020.
[5] Industry publications on healthcare infrastructure and diagnostic imaging adoption.