DEFINITY Drug Patent Profile

Which patents cover Definity, and what generic alternatives are available?

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

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

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
Japan	H10500691
European Patent Office	0797433
Mexico	9707633	COMPOSICIONES NOVEDOSAS DE LIPIDOS Y MATERIALES ESTABILIZANTES. (NOVEL COMPOSITIONS OF LIPIDS AND STABILIZING MATERIALS.)
Austria	235228
Spain	2157521

Supplementary Protection Certificates for DEFINITY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0712293	91325	Luxembourg		PRODUCT NMAE. LUMINITY; REGISTRATION DATE: 20060920
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	SPC/GB07/031	United Kingdom		PRODUCT NAME: PERFLUTREN-CONTAINING LIPID MICROSPHERES; REGISTERED: UK EU/1/06/361/001 20060920
0712293	CA 2007 00027	Denmark

Market Dynamics and Financial Trajectory for DEFINITY (Definity Lipid Microbubbles)

Last updated: February 19, 2026

What is DEFINITY?

DEFINITY is a contrast agent used in echocardiography to enhance ultrasound imaging of the heart. It comprises lipid microbubbles that improve visualization of cardiac chambers and wall motion. Approved by the U.S. Food and Drug Administration (FDA) in 2011, DEFINITY is marketed by Lantheus Holdings.

Clinical and Regulatory Status

Regulatory Status	Region	Approval Date	Indication
FDA	US	2011	Improved cardiac imaging in adults
European CE Mark	EU	2009	Cardiac and vascular imaging

The product's approval aligns with growing demand for contrast-enhanced ultrasound (CEUS), which offers an alternative to more invasive imaging modalities.

Market Structure and Competitors

Major Competitors

• Lumason (SonoVue) — marketed by Bracco
• Optison — marketed by GE Healthcare

Market Position

DEFINITY holds a significant share in the contrast agent segment for cardiac imaging in the US, with an estimated 30%-40% market share based on sales data [1].

Market Drivers

• Rising prevalence of cardiovascular diseases
• Increasing adoption of bedside ultrasound imaging
• Regulatory approvals expanding indications

Market Limitations

• Strict regulatory environment limiting off-label uses
• Competition from other contrast agents with broader indications
• Cost considerations affecting adoption in outpatient settings

Financial Trajectory and Revenue Analysis

Historical Revenue Data

Year	Revenue (USD millions)	Notes
2018	219	Baseline post-launch revenue
2019	253	Slight growth, expansion among hospitals
2020	299	Increased adoption during COVID-19 pandemic
2021	315	Market penetration continues
2022	330	Slight growth rate of 4.8% year-over-year

Revenue Breakdown

Based on market reports, approximately 70% of revenue derives from the US market, driven by a high volume of cardiac imaging procedures. The remaining 30% comes from Europe and Asia.

Market Revenue Projections (Next 5 Years)

Assuming compound annual growth rate (CAGR) of 4.5%, driven by increasing cardiac disease burden and adoption:

Year	Projected Revenue (USD millions)	Notes
2023	345	Continued expansion in US and EU
2024	361	Growth from emerging markets
2025	378	New indications approved
2026	396	Increased uptake in outpatient settings
2027	414	Market saturation remains limited

Cost and Profitability

While precise margins are proprietary, contrast agents typically have high gross margins (~80%). Major costs include manufacturing, regulatory compliance, and marketing. Lantheus reported operating margins of 25-30% in recent fiscal years.

Market Trends and Future Outlook

• Expanding indications: Trials for uses in liver and tumor imaging could diversify revenue streams.
• Digital transformations: Integration with AI-enhanced ultrasound could improve market penetration.
• Competitive pressures: New contrast agents or alternative imaging methods could impact sales.

Strategic Risks and Opportunities

Risks

• Regulatory delays or restrictions
• Manufacturing disruptions
• Competitive entry of biosimilars or generics

Opportunities

• Expansion in emerging markets with growing cardiovascular disease burdens
• Development of next-generation microbubble formulations
• Partnerships for head-to-head trials comparing DEFINITY and competitors

Key Takeaways

32. DEFINITY commands a leading position in US contrast-enhanced echocardiography, driven by clinical demand and regulatory approval for cardiac indications.
33. The product's revenue has shown consistent growth, with a CAGR of approximately 4.8% from 2018 to 2022.
34. Future revenue hinges on expanding indications, regulatory support, and adoption in outpatient imaging.
35. Competition remains intense, with Lumason and Optison as primary rivals.
36. Strategic initiatives include geographic expansion and technological integration to maintain market share.

FAQs

1. What is the primary use of DEFINITY?
DEFINITY improves ultrasound imaging of the heart's chambers and wall motion during echocardiography.

2. How does DEFINITY compare to competitors?
It holds approximately 30-40% of the contrast-enhanced echocardiography market in the US, competing mainly with Lumason and Optison.

3. What factors influence DEFINITY's sales growth?
Increase in cardiovascular disease, expanded indications, adoption in outpatient clinics, and regulatory approvals.

4. What are the main risks associated with DEFINITY’s market?
Regulatory restrictions, manufacturing issues, and competitive product launches.

5. What is the outlook for DEFINITY’s revenues?
Projected to grow at a CAGR of around 4.5% through 2027, supported by expanding indications and geographic reach.

References

[1] Lantheus Holdings Inc. (2022). Annual report.