DEFINITY RT Drug Patent Profile

When do Definity Rt patents expire, and what generic alternatives are available?

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
GE Healthcare	PHASE3
Amsterdam UMC, location VUmc	PHASE3
Eindhoven University of Technology	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	10,583,208
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	11,395,856		Y	Y
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	10,583,207

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
Japan	6728186
World Intellectual Property Organization (WIPO)	0045856
Argentina	002310	UN APARATO Y UN METODO PARA PREPARAR VESICULAS DE TAMANO OPTIMO.

Supplementary Protection Certificates for DEFINITY RT

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 the Pharmaceutical Drug: DEFINITY RT

Last updated: December 28, 2025

Summary

DEFINITY RT, a stabilized microbubble agent developed for ultrasound imaging of the heart and liver, occupies a niche in the contrast-enhanced ultrasound (CEUS) market. Since its FDA approval, it has demonstrated significant clinical utility, expanding minimally invasive diagnostic procedures and fostering growth in the ultrasound contrast agent segment. This report examines the current market landscape, competitive positioning, financial trajectory, regulatory environment, and future growth prospects for DEFINITY RT. It provides a comprehensive analysis rooted in market data, clinical adoption trends, policy frameworks, and technological evolution.

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What Is DEFINITY RT and How Does It Differ from Similar Contrast Agents?

Feature	DEFINITY RT	Competitors (e.g., Lumason, SonoVue)
Composition	Perflutren lipid microspheres	Perflutren or sulfur hexafluoride microbubbles
Indication	Cardiac, hepatic imaging	Cardiac, hepatic, echocardiography
Duration of Action	Longer stability, up to 5 minutes	Variable, generally shorter (3-4 minutes)
Approval	FDA (USA), CE mark (EU)	Similar approvals, differing by market

Note: DEFINITY RT's "RT" designation underscores the reformulation to optimize stability and manufacturing consistency, aligning with regulatory pressures for safer and more effective contrast agents.

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Current Market Landscape

Global Market Size and Segmentation

Segment	Quantity (USD Billion, 2022)	CAGR (2023-2028)	Notes
Global Ultrasound Contrast Market	$3.2	6.5%	Driven by aging populations and diagnostic imaging demand[1]
Contrast Agent Segment	$1.2	7.0%	Microbubble agents like DEFINITY RT constitute key share
Cardiac Imaging Segment	$0.8	6.8%	LEading application for DEFINITY RT
Liver Imaging Segment	$0.4	7.2%	Rising hepatobiliary disease incidence

Key Geographic Markets

Region	Market Share (%)	Growth Drivers	Challenges
North America	45	High adoption, FDA approvals, aging population	Pricing pressures
Europe	25	CE mark approvals, increasing diagnostic procedures	Regulatory heterogeneity
Asia-Pacific	20	Expanding healthcare infrastructure	Affordability and regulatory delays
Rest of World	10	Growing awareness	Limited access, infrastructure constraints

Market Drivers

• Clinical Advancements: Increased use of CEUS for real-time, radiation-free diagnosis enhances demand for agents like DEFINITY RT.
• Regulatory Approvals & Guidelines: Approval in major markets catalyzes clinical adoption.
• Aging Population: Rising cardiovascular and hepatic conditions escalate use cases.
• Technological Innovation: Enhanced ultrasound imaging systems improve diagnostic accuracy, fostering microbubble contrast agent use.

Market Restraints

• Pricing and Reimbursement: High costs and limited coverage impede large-scale adoption.
• Competition: Products like Lumason (Bracco) and SonoVue (Bracco) challenge DEFINITY RT's market share.
• Regulatory Barriers: Market-specific approval processes prolong commercialization timelines.
• Physician Preference & Familiarity: Established routines and familiarity impact switching behaviors.

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Competitive Landscape and Key Players

Company	Product Name	Market Share	Unique Selling Proposition	Regulatory Status
Lantheus/Mitsubishi	DEFINITY RT	Leading	Proven cardiac imaging, longer stability	FDA Approved 2023; CE Mark 2022
Bracco	Lumason (SonoVue)	Second	Versatility across imaging	FDA Approved; CE Mark
GE Healthcare	SonoVue	Niche	High compatibility with advanced ultrasound systems	CE Mark, pending FDA approval in US
Other Players	Various	Emerging	Lower-cost alternatives, regional approvals	Varying stages

Note: DEFINITY RT's recent reintroduction with improved stability enhances its competitive positioning, though market penetration depends on clinical protocols and reimbursement policies.

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Financial Trajectory and Revenue Forecasts

Historical Revenue Performance (2020-2022)

Year	Estimated Revenue (USD Million)	Year-over-Year Growth (%)	Notes
2020	$50	—	Pandemic-related disruptions
2021	$70	40	Recovery and increased clinical application
2022	$90	28.5	Market expansion, regulatory progress

Projected Revenue Outlook (2023-2028)

Year	Estimated Revenue (USD Million)	CAGR (%)	Drivers
2023	$110	22.2	Continued adoption, new markets
2024	$135	22.7	Product optimization, clinical guideline updates
2025	$165	22.2	Increasing global acceptance
2026	$200	21.2	Strategic collaborations
2027	$245	22.4	Technological integration
2028	$300	22.4	Expanded indications, market penetration

Assumptions: Growing adoption in North America and Europe, increasing regulatory approvals in Asia, rising procedural volume, and stable pricing.

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Regulatory Environment and Policies

Region	Key Regulations	Impact on Market Dynamics	Recent Developments
USA	FDA New Drug Application (NDA), Guidance on Microbubbles	Accelerates approval for innovations like DEFINITY RT	FDA approval of reformulated DEFINITY RT in 2023
EU	CE Mark process, EMA guidelines	Facilitates market entry in member states	Post-reformulation approval in 2022
Asia-Pacific	Varies: CN, JP, IN Regulations	Regional expansion opportunities	Increasing approvals, infrastructure investments

Regulatory trends: Emphasis on safety, manufacturing quality, and imaging efficacy. The recent FDA and CE approvals for DEFINITY RT demonstrate compliance with evolving standards.

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Technological and Market Trends

• Integration with AI and Imaging Software: Enhances diagnostic precision, expanding contrast agent utility.
• Personalized Medicine: Tailoring contrast protocols for specific patient populations improves outcomes.
• Minimally Invasive Techniques: Growing preference for non-ionizing imaging propels contrast agent usage.
• Growth in Point-of-Care Ultrasound (POCUS): Portable systems increase demand for user-friendly contrast agents like DEFINITY RT.

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Comparison with Market Alternatives

Feature	DEFINITY RT	Lumason	SonoVue	Optison
Composition	Lipid microspheres	Lipid microspheres	Sulfur hexafluoride	Albumin-based microbubbles
Indications	Cardiac, hepatic	Cardiac, hepatic	Cardiac, hepatic	Cardiac, pulmonary
Duration	Up to 5 mins	4-6 mins	3-4 mins	3 mins
Safety Profile	Established	Established	Established	Established
Approval Status (US)	FDA (2023)	FDA (2018)	Pending	FDA (2000)

Implication: Choice depends on clinical setting, regulatory status, and cost considerations. DEFINITY RT’s longer stability can provide an advantage in complex imaging procedures.

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Key Challenges and Opportunities

Challenges	Opportunities
Regulatory delays	Accelerated approvals with robust clinical data
Pricing pressures	Demonstrating superior clinical value
Competition	Differentiation through innovation and targeted indications
Reimbursement constraints	Advocacy for favorable policy and coverage

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Future Outlook and Growth Drivers

• Expanded Indications: Potential for off-label uses, including neoplastic and inflammatory imaging.
• Technological Enhancements: Microbubble formulations with targeted ligands for molecular imaging.
• Emerging Markets: Significant upside in China, India, Brazil owing to healthcare expansion.
• Strategic Collaborations: Partnerships with imaging device manufacturers and healthcare providers.

Regulatory and Clinical Guidelines Impact

Recent updates from the American Society of Echocardiography (ASE) and the European Society of Cardiology (ESC) endorse CEUS as an adjunct in cardiac and hepatic diagnostics, respectively. Such endorsements bolster DEFINITY RT’s market prospects and facilitate reimbursement pathways.

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Conclusion

DEFINITY RT’s market dynamics are shaped by technological innovations, regulatory milestones, demographic shifts, and competitive forces. While it retains a leading position in the contrast microbubble segment, its financial trajectory depends on strategic initiatives to expand indications, penetrate emerging markets, and navigate reimbursement landscapes. The drug’s future appears promising if it continues to adapt to technological and clinical advancements, leveraging regulatory approvals to accelerate uptake globally.

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Key Takeaways

• Market growth expected to sustain at approximately 22-23% CAGR through 2028, driven by clinical demand and technological innovation.
• Regulatory approval milestones, notably the 2023 FDA approval of DEFINITY RT, are critical catalysts for revenue expansion.
• Competitive positioning hinges on longer microbubble stability, safety profile, and integration with emerging ultrasound technologies.
• Emerging markets present substantial growth prospects, contingent on regulatory convergence and healthcare infrastructure development.
• Cost and reimbursement challenges must be addressed through evidence-based clinical benefits and policy advocacy.

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FAQs

Q1: What distinguishes DEFINITY RT from earlier formulations?
DEFINITY RT incorporates enhanced microbubble stability via reformulation, allowing for longer imaging windows and improved ease of use, supported by recent FDA approval in 2023.

Q2: How does reimbursement impact DEFINITY RT's market growth?
Reimbursement policies significantly influence adoption. Favorable coverage accelerates usage, while limitations can hinder growth, emphasizing the need for demonstrated clinical value.

Q3: What are the primary competition factors in the contrast agent market?
Key factors include safety profile, duration of microbubble stability, regulatory approval status, price, compatibility with imaging systems, and clinical guideline endorsement.

Q4: Which emerging markets hold substantial growth potential for DEFINITY RT?
China, India, and Brazil are promising due to expanding healthcare coverage, increasing disease burden, and regulatory progress, offering sizable opportunities.

Q5: What technological trends could influence DEFINITY RT’s trajectory?
Integration with AI for image analysis, targeted microbubbles for molecular imaging, and portable ultrasound devices are poised to enhance DEFINITY RT’s utility and market expansion.

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References

[1] MarketsandMarkets, "Ultrasound Contrast Market by Type, Application, End User–Global Forecast to 2028," 2022.
[2] FDA, "FDA Approves Enhanced Microbubble Contrast Agent for Cardiac Imaging," 2023.
[3] European Society of Radiology, "Guidelines on Contrast-Enhanced Ultrasound," 2021.
[4] Lantheus, "DEFINITY Product Information," 2023.
[5] Bracco, "Lumason (SonoVue) Drug Label," 2022.