DEFINITY Drug Patent Profile

When do Definity patents expire, 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

US Patents and Regulatory Information for DEFINITY

DEFINITY is protected by nine US patents.

This potential generic entry date is based on patent 5,527,521.

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	9,789,210
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	11,266,750
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes	11,857,646
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes	10,583,208
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	9,789,210
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	10,022,460		Y	Y
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes	11,266,750

International Patents for DEFINITY

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	201815424	Methods for making ultrasound contrast agents
South Korea	20180133527
Israel	263205	שיטות להכנת גורמי חדות על-קולי (Methods for making ultrasound contrast agents)
Taiwan	I821755
Germany	69231830
European Patent Office	1064953
Canada	2362200

Supplementary Protection Certificates for DEFINITY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0712293	300267	Netherlands		300267, 20140520, EXPIRES: 20190519
0712293	CA 2007 00027	Denmark
0712293	SPC/GB07/031	United Kingdom		PRODUCT NAME: PERFLUTREN-CONTAINING LIPID MICROSPHERES; REGISTERED: UK EU/1/06/361/001 20060920
0712293	SPC018/2007	Ireland		SPC018/2007: 20071012, EXPIRES: 20190519
0712293	C300267	Netherlands		PRODUCT NAME: PERFLUTREN BEVATTENDE LIPIDE-MICROBOLLEN; REGISTRATION NO/DATE: EU/1/06/361/001 20060920
0712293	91325	Luxembourg		PRODUCT NMAE. LUMINITY; REGISTRATION DATE: 20060920
0712293	0790017-8	Sweden		PRODUCT NAME: LIPIDMIKROSFAERER INNEHALLANDE PERFLUTREN; REG. NO/DATE: EU/1/06/361/001 20060920

DEFINITY Investment Scenario and Fundamentals Analysis

Last updated: February 20, 2026

What is DEFINITY?

DEFINITY (perflutren lipid microspheres) is a contrast agent used in echocardiography to enhance ultrasound imaging of the heart. It received FDA approval in 2004 for adult patients and is primarily marketed as a diagnostic tool in cardiovascular imaging. The drug is produced and marketed by Lantheus Holdings, Inc.

Market Overview

The global ultrasound contrast agent market was valued at approximately USD 900 million in 2022 and is projected to grow at a CAGR of 7-8% through 2030. The rising prevalence of cardiovascular diseases (CVD), especially in aging populations, drives demand for diagnostic imaging. US and European markets account for roughly 70% of the revenue, with emerging markets expanding.

Revenue and Market Share

Lantheus reported USD 477 million in total revenue in 2022, with ultrasound contrast agents, including DEFINITY, constituting 75% of sales [1]. DEFINITY is a leading product behind competitors like Bracco's Lumason.

Competitive Position

Asset	Market Share (2022)	Key Features	Licensing Risks
DEFINITY	~50%	Approved for adult use, excellent safety profile	Market saturation, patent expirations (2029)
Lumason	~40%	Approved for pediatric use, flexible dosing	Regional approvals vary
Others	~10%	Limited market penetration	Regulatory hurdles

Regulatory Environment

• FDA approval since 2004.
• European CE-Mark since 2003.
• Ongoing discussions on expanding indications for cardiac and oncological imaging.

Patent exclusivity is set to expire around 2029, opening potential for biosimilar competition.

Financial Fundamentals

Metric	2022 Data	Comments
Total Revenue	USD 477 million	Slight growth YoY, driven by US sales
R&D Expenses	USD 40 million	Focused on new formulations and indications
Operating Margin	30%	Consistent with industry standards
Net Income	USD 100 million	Stable profitability
Cash & Equivalents	USD 125 million	Sufficient for R&D and strategic plans

Investment Risks

• Patent expiration in 2029 risks generic erosion.
• Market saturation in mature regions.
• Regulatory delays for expansion into new indications.
• Competition from emerging contrast agents, including microbubble-based formulations with enhanced safety profiles.

Growth Drivers

• Increasing prevalence of CVD globally.
• Expansion into niche imaging markets (e.g., stress echocardiography).
• Potential for label expansion with clinical trial support.
• Clinical adoption of contrast-enhanced ultrasound procedures.

Financial Outlook

Projection assumes steady growth in US and European markets. Launch of new indications or formulations could increase revenue. Patent expiry around 2029 may pressure margins; potential biosimilar entry could erode price points.

Valuation Considerations

With a market cap estimated at USD 2.5 billion, valuation multiples stand at approximately 5.2x trailing revenue. Any strategic moves, such as R&D advances or licensing deals, could impact valuation.

Strategic Opportunities and Challenges

Opportunities:

• Licensing agreements to extend patent exclusivity.
• Expansion into pediatric and oncological imaging.
• Development of next-generation contrast agents with improved safety profiles.

Challenges:

• Patent cliffs looming beyond 2029.
• Competitive innovations in contrast technology.
• Market maturation and pricing pressures.

Key Takeaways

• DEFINITY is a leading ultrasound contrast agent with a stable financial profile.
• Its growth is tied to increasing cardiovascular disease prevalence and imaging adoption.
• Patent expiration in 2029 poses a significant risk; biosimilar competition could dilute market share.
• Expansion into new indications and markets offers upside potential.
• Strategic licensing and R&D can extend product lifecycle and preserve margins.

FAQs

1. When do patent protections for DEFINITY expire?
Patents are expected to expire around 2029, opening the market to biosimilar competition.

2. What is the primary driver of DEFINITY’s revenue growth?
Expansion of contrast-enhanced ultrasound procedures in cardiology-related diagnostics, especially in the US and Europe.

3. How does competition impact DEFINITY’s market position?
Bulk of market share is held by DEFINITY and Lumason; competition from biosimilars and innovative contrast agents could erode profitability.

4. What are the key regulatory considerations?
Regulatory approvals for new indications and regions can influence growth. Patent expiration and biosimilar approvals are critical for long-term viability.

5. What prospects exist for expanding DEFINITY’s clinical applications?
Label expansion into stress echocardiography, congenital heart disease, and oncology imaging could drive additional revenue.

References

[1] Lantheus Holdings, Inc. (2022). Annual Report.