DEFINITY Drug Patent Profile

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

Definity 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 is perflutren. One supplier is listed for this compound. Additional details are available on the perflutren profile page.

DrugPatentWatch^® Generic Entry Outlook for Definity

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 4, 2037. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DEFINITY

International Patents:	81
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	69
Patent Applications:	3,644
Drug Prices:	Drug price information for DEFINITY
What excipients (inactive ingredients) are in DEFINITY?	DEFINITY excipients list
DailyMed Link:	DEFINITY at DailyMed

See drug prices for DEFINITY

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

NDA:

021064

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 DEFINITY

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

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

See all DEFINITY clinical trials

Pharmacology for DEFINITY

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

US Patents and Regulatory Information for DEFINITY

DEFINITY is protected by nine US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Expired US Patents for DEFINITY

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 DEFINITY

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

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

Country	Patent Number	Title	Estimated Expiration
Portugal	788348
Canada	2177713
European Patent Office	3458110	PROCÉDÉS DE PRODUCTION D'AGENTS DE CONTRASTE D'ULTRASONS. (METHODS FOR MAKING ULTRASOUND CONTRAST AGENTS)
South Korea	20180133527
European Patent Office	0511273	LIPOSOMES UTILISES COMME AGENTS DE CONTRASTE POUR IMAGERIE ULTRASONIQUE (LIPOSOMES AS CONTRAST AGENTS FOR ULTRASONIC IMAGING)
World Intellectual Property Organization (WIPO)	2016109400

Supplementary Protection Certificates for DEFINITY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0712293	SPC018/2007	Ireland		SPC018/2007: 20071012, EXPIRES: 20190519
0712293	91325	Luxembourg		PRODUCT NMAE. LUMINITY; REGISTRATION DATE: 20060920
0712293	300267	Netherlands		300267, 20140520, 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

Last updated: July 28, 2025

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Introduction

DEFINITY, a diagnostic ultrasound contrast agent approved by the U.S. Food and Drug Administration (FDA), plays a pivotal role in enhancing imaging quality for echocardiography. As a microbubble-based contrast agent, it improves the visualization of cardiac chambers, valvular morphology, and intracardiac shunts. Its unique composition and clinical utility position it within a specialized yet competitive segment of the diagnostic imaging market. Evaluating the market dynamics and financial trajectory of DEFINITY involves understanding clinical demand, competitive landscape, regulatory factors, and technological advancements shaping its commercial prospects.

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Market Overview and Demand Drivers

The global diagnostic imaging market is experiencing robust growth driven by technological innovation, aging populations, and increasing prevalence of cardiovascular diseases (CVDs). CVDs remain the leading cause of mortality worldwide, accounting for over 17 million deaths annually. Precise cardiac imaging is crucial for diagnosis, management, and monitoring, underpinning demand for contrast agents like DEFINITY.

Key demand drivers include:

• Rising Incidence of Cardiovascular Diseases: The global burden of heart failure, ischemic heart disease, and valvular disorders significantly fuels the need for advanced imaging techniques where DEFINITY is utilized.

• Aging Population: Older adults are more prone to complex cardiac conditions necessitating enhanced imaging, thus increasing the use of contrast-enhanced echocardiography.

• Technological Advancements in Ultrasound Imaging: Innovations leading to higher-resolution imaging and better detection capabilities bolster the adoption of contrast agents.

• Regulatory Approvals and Expanding Indications: Approval for additional cardiac and non-cardiac indications broadens potential patient populations.

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Competitive Landscape

DEFINITY competes within the contrast agent market alongside alternatives such as Definity (also produced by Lantheus), Lumason/Sonovue (Bracco), and other emerging agents. The market favors agents with proven safety profiles, cost-effectiveness, and ease of use.

Key competitive factors include:

• Safety and Tolerance: DEFINITY has demonstrated a favorable safety profile with low adverse event rates, a critical factor in clinician preference.

• Regulatory Approvals: Favorable regulatory status in the U.S. and Europe enhances market access, but delays or restrictions can impact market share.

• Brand Recognition and Clinical Evidence: Strong clinical data supporting DEFINITY’s efficacy influence adoption rates.

• Pricing Strategies: Competitive pricing relative to alternatives influences hospital and imaging provider decisions.

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Regulatory and Reimbursement Environment

Reimbursement landscapes greatly influence the financial viability of contrast agents like DEFINITY. Historically, reimbursement policies have favored contrast-enhanced echocardiography when performed with approved agents, but variability across regions persists.

• United States: Medicare and private insurers typically reimburse contrast-enhanced echocardiography, but the extent depends on regional policies and coding.

• Europe and Asia: Variability exists; some markets have integrated contrast agent reimbursement into standard echocardiography procedures while others are still developing policies.

Regulatory Hurdles: Expanding approvals for additional indications or formulations could enhance utilization, though delays or restrictions pose risks.

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Technological Innovations and Market Trends

Continuous advances in ultrasound technology and microbubble formulations influence DEFINITY’s market trajectory.

• Microbubble Technology: Innovations could lead to agents with longer circulation times, higher stability, or targeted imaging capabilities, affecting DEFINITY’s competitiveness.

• Integration with Quantitative Imaging: The trend toward quantitative and molecular imaging could either augment DEFINITY’s utility or pressure it to evolve.

• Emerging Therapeutic Roles: Research into microbubbles for drug delivery and theranostics could create adjacent revenue streams, although currently limited.

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Financial Trajectory and Revenue Analysis

Lantheus, the manufacturer of DEFINITY, reports revenues primarily driven by contrast agents. Considering the specific dynamics:

• Revenue Growth: The contrast agent market has exhibited steady growth, with some fluctuations due to pandemic-related decreases in elective procedures. Post-pandemic, recovery is accelerating.

• Market Penetration: While DEFINITY retains a substantial market share within the U.S., international expansion remains critical, with emerging markets offering significant upside potential.

• Pricing and Volume: Price erosion is observed in some regions due to increased competition, but volume growth offsets declining unit prices, supporting revenue stability.

• Profitability: Cost efficiencies in manufacturing and distribution, coupled with high-margin pricing, underpin profitability. Regulatory costs for expanded indications could temporarily pressure margins, but long-term benefits outweigh these costs.

Future Outlook and Growth Opportunities

The future financial trajectory for DEFINITY hinges on several factors:

• Expansion of Indications: Approval for additional cardiac and non-cardiac applications can expand patient pools.

• Market Expansion: Penetration into emerging markets where cardiovascular disease burdens are rising is vital.

• Research and Development: Investment in next-generation contrast agents with enhanced features can sustain competitive edge.

• Partnerships and Collaborations: Strategic alliances with healthcare providers and imaging technology firms support stronger market adoption.

Risks include:

• Competition from innovative microbubble agents and alternative imaging modalities (e.g., cardiac MRI, nuclear imaging).

• Regulatory bottlenecks delaying new indications.

• Pricing pressures amid healthcare cost containment initiatives.

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Conclusion

The market dynamics for DEFINITY are characterized by steady demand fueled by the global rise in cardiovascular diseases, technological advances in imaging, and favorable regulatory endorsements. While competition and pricing pressures pose challenges, the overall financial trajectory appears positive, supported by expanding indications and international market penetration.

Long-term growth potential hinges on continued innovation, strategic regulatory navigation, and market expansion efforts. Investors and healthcare providers should monitor regulatory developments, technological trends, and regional reimbursement policies to effectively gauge DEFINITY’s future performance.

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Key Takeaways

• The rising prevalence of cardiovascular disorders globally sustains demand for contrast-enhanced echocardiography, underpinning DEFINITY’s market prospects.

• Competitive differentiation through safety, efficacy, and cost-effectiveness remains crucial amid evolving technological landscapes.

• International expansion and indication diversification constitute key strategies to unlock growth opportunities.

• Regulatory and reimbursement environments significantly influence market penetration and revenue potential.

• Innovation in microbubble technology and integration with advanced imaging modalities will shape DEFINITY’s short-to-medium-term financial trajectory.

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FAQs

1. What distinguishes DEFINITY from its competitors in the contrast agent market?
DEFINITY's key differentiators include its proven safety profile, FDA approval for multiple cardiac indications, and proven efficacy in enhancing echocardiographic imaging, providing clinicians with reliable diagnostic enhancement.

2. How do regulatory approvals impact DEFINITY’s market growth?
Regulatory approvals are essential for market access. Expanded indications and approvals in new regions can significantly boost sales, whereas delays or restrictions may impede growth.

3. What are the primary challenges facing DEFINITY’s market expansion?
Challenges include stiff competition from alternative agents and imaging modalities, pricing pressures, and regulatory hurdles governing new indications or formulations.

4. How does reimbursement influence the financial trajectory of DEFINITY?
Reimbursement policies determine the affordability and adoption of contrast-enhanced echocardiography. Favorable reimbursement promotes higher procedure volumes and revenue, but policy variability can limit growth.

5. What future innovations could enhance DEFINITY’s market position?
Next-generation microbubbles with targeted imaging capabilities, longer circulation times, or therapeutic potential, coupled with integration into advanced imaging platforms, could sustain and grow DEFINITY’s market share.

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Sources

1. [1] Lantheus Holdings. "DEFINITY (Luminity) Cardiac Microbubble Diagnostic Agent." FDA Labeling Documentation.
2. [2] MarketsandMarkets. "Contrast Agents Market by Product & Application."
3. [3] American Heart Association. "Cardiovascular Disease Statistics."
4. [4] Regulatory Agencies. "FDA Approvals for Ultrasound Contrast Agents."
5. [5] Company Financial Reports. Lantheus Holdings Annual and Quarterly Reports (2022-2023).