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 seventy-five 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:	75
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	65
Patent Applications:	3,529
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

Constraining patent/regulatory exclusivity:

5,527,521

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
Sunnybrook Health Sciences Centre	Phase 2
Terry Fox Research Institute	Phase 2
InSightec	Phase 2

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.

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

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	6,033,645
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001	6,146,657
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001	5,527,521
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001	6,528,039
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001	9,545,457

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/000654 This 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/000166 This 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
Australia	694973
Israel	296876	שיטות והתקנים להכנת גורמי חדות לאולטרסאונד (Methods and devices for preparation of ultrasound contrast agents)
Australia	2115599
Canada	2218541
Israel	252705	תכשירי מיקרוספרת גז עטוף בשומן ושיטות קשורות (Lipid-encapsulated gas microsphere compositions and related methods)

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	CA 2007 00027	Denmark
0712293	300267	Netherlands		300267, 20140520, EXPIRES: 20190519
0712293	C300267	Netherlands		PRODUCT NAME: PERFLUTREN BEVATTENDE LIPIDE-MICROBOLLEN; REGISTRATION 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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DEFINITY

Last updated: July 3, 2025

Introduction

In the fast-evolving pharmaceutical landscape, understanding the market forces and financial paths of key drugs is essential for investors, executives, and analysts. DEFINITY, a leading ultrasound contrast agent developed by Lantheus Medical Imaging, exemplifies how innovation in diagnostic imaging intersects with economic realities. This article dissects the current market dynamics and financial trajectory of DEFINITY, offering actionable insights for business professionals navigating the $50 billion global contrast media market.

Overview of DEFINITY

DEFINITY, known scientifically as perflutren lipid microspheres, serves as an essential tool in echocardiography by enhancing the visibility of the left ventricle and improving endocardial border delineation. First approved by the U.S. Food and Drug Administration (FDA) in 2001, this injectable agent has become a staple in non-invasive cardiac imaging, particularly for patients with suboptimal echocardiograms. Lantheus markets it primarily in the United States and select international regions, where it addresses growing demands for accurate cardiovascular diagnostics amid rising heart disease prevalence.

The drug's unique microbubble technology allows for real-time imaging, differentiating it from traditional contrast agents. In 2023, DEFINITY generated approximately $300 million in annual revenue for Lantheus, underscoring its role in the company's portfolio. As healthcare systems prioritize early detection of cardiac conditions, DEFINITY's adoption continues to climb, especially in hospitals and outpatient clinics equipped for advanced ultrasound procedures.

Market Dynamics Shaping DEFINITY

The market for ultrasound contrast agents like DEFINITY is influenced by several interconnected factors, including regulatory shifts, technological advancements, and competitive pressures. Globally, the contrast media sector is projected to expand at a compound annual growth rate (CAGR) of 5.5% through 2028, driven by an aging population and increasing incidences of chronic diseases such as heart failure and stroke.

Regulatory environments play a pivotal role. The FDA's ongoing evaluations, including post-market surveillance for safety, have bolstered DEFINITY's reputation as a reliable option. For instance, in 2022, the agency reaffirmed its approval status after reviewing real-world data, which highlighted a low incidence of adverse events. This stability attracts healthcare providers in regulated markets like the EU and Japan, where similar bodies enforce stringent standards.

Competition intensifies the dynamics. DEFINITY faces rivals such as Bracco's SonoVue and GE Healthcare's Optison, but it maintains an edge through superior imaging quality and a broader reimbursement landscape. In the U.S., Medicare and private insurers often cover DEFINITY for qualifying procedures, boosting its market penetration. However, emerging biosimilars and generic alternatives threaten to erode its share, particularly as patents on similar agents expire.

Economic factors, including supply chain disruptions, have also impacted availability. The COVID-19 pandemic exposed vulnerabilities, with DEFINITY's production delays in 2021 leading to temporary shortages and price fluctuations. Despite this, global demand rebounded strongly, with sales volumes increasing by 15% in 2023 compared to the previous year, according to industry reports.

Geographically, North America dominates DEFINITY's market, accounting for over 60% of sales, fueled by high healthcare spending and advanced imaging infrastructure. Emerging markets in Asia-Pacific, however, present growth opportunities as countries like China and India invest in cardiac care facilities. Lantheus is capitalizing on this by expanding distribution partnerships, potentially adding $50 million in annual revenue from these regions by 2025.

Financial Trajectory of DEFINITY

Lantheus's financial performance reflects DEFINITY's steady contributions amid broader pharmaceutical trends. From 2019 to 2023, the drug's revenue grew from $250 million to $300 million, achieving a CAGR of 4.7%. This growth stems from strategic pricing adjustments and volume increases, with the company reporting gross margins above 70% on DEFINITY sales.

Investors track key metrics like earnings before interest, taxes, depreciation, and amortization (EBITDA), which for Lantheus hit $150 million in 2023, partly driven by DEFINITY. The drug's profitability supports R&D investments, including enhancements to its microbubble formulation for broader applications, such as liver imaging. These innovations could extend DEFINITY's lifecycle, projecting an additional $100 million in revenue by 2026.

Cash flow analysis reveals resilience. Lantheus generated $200 million in operating cash flow in 2023, with DEFINITY accounting for a significant portion. This financial health enables dividend payments and stock buybacks, appealing to shareholders. However, external pressures, such as inflation-driven cost increases for raw materials, have squeezed margins, prompting price hikes of 5-7% in 2023.

Looking ahead, DEFINITY's trajectory aligns with industry consolidation. Lantheus's acquisition of Progenics Pharmaceuticals in 2020 indirectly strengthened its position by diversifying revenue streams, reducing reliance on DEFINITY to about 40% of total sales. Analysts forecast sustained growth, with revenue potentially reaching $350 million by 2025, assuming no major regulatory setbacks.

Valuation models, such as discounted cash flow (DCF) analyses, value DEFINITY's future contributions at over $1 billion in net present value for Lantheus. This optimism hinges on market expansion and patent protections, which extend through 2028 in key territories, shielding it from immediate generic threats.

Challenges and Opportunities

Despite its strong position, DEFINITY confronts challenges that could alter its market dynamics. Safety concerns, though rare, include potential allergic reactions, leading to FDA-mandated labeling updates in 2022. These issues demand vigilant pharmacovigilance, potentially increasing compliance costs by 10-15%.

On the opportunity side, the rise of personalized medicine opens doors. Integrating DEFINITY with AI-driven ultrasound systems could enhance diagnostic accuracy, creating new revenue channels. Lantheus is exploring these synergies, with pilot programs in U.S. hospitals showing a 20% improvement in imaging outcomes.

Global expansion represents another avenue. As healthcare infrastructure in Latin America and the Middle East improves, DEFINITY could capture an additional 10% market share. Strategic alliances, like Lantheus's partnership with a major Asian distributor in 2023, position the company to exploit these trends.

Future Outlook

As the pharmaceutical sector evolves, DEFINITY's future hinges on adaptability. With the contrast agents market expected to hit $7 billion by 2030, DEFINITY could outpace averages through innovation and market penetration. Lantheus plans to invest $50 million in R&D by 2025, focusing on next-generation formulations that reduce administration times and expand indications.

Stakeholders should monitor macroeconomic factors, such as interest rate changes, which could affect healthcare budgets and drug pricing. If current trends persist, DEFINITY will likely maintain its leadership, delivering robust returns for investors.

Key Takeaways

• DEFINITY's revenue growth of 4.7% CAGR from 2019-2023 highlights its stability in the expanding contrast media market.
• Regulatory approvals and high reimbursement rates in North America sustain its competitive edge against rivals.
• Financial metrics, including strong EBITDA and cash flow, underscore Lantheus's ability to fund future innovations.
• Emerging markets and technological integrations offer growth potential, though safety and supply chain risks persist.
• Business professionals should prioritize DEFINITY for portfolios focused on diagnostic imaging, given its projected revenue increases.

FAQs

1. What factors primarily drive DEFINITY's market growth?
DEFINITY's growth stems from increasing demand for advanced cardiac imaging, favorable FDA regulations, and expanding reimbursement policies, particularly in North America.

2. How does DEFINITY compare financially to competing drugs?
DEFINITY outperforms competitors like SonoVue in revenue generation, with higher gross margins due to its established market presence and premium pricing.

3. What risks could impact DEFINITY's financial trajectory?
Key risks include potential generic entrants post-patent expiration in 2028 and supply chain disruptions, which could reduce sales volumes and margins.

4. How is Lantheus positioning DEFINITY for future expansion?
Lantheus is investing in R&D for new formulations and forming international partnerships to penetrate emerging markets, aiming to boost revenue by 2025.

5. Why should business professionals track DEFINITY's performance?
Monitoring DEFINITY provides insights into the broader diagnostic imaging sector, helping professionals anticipate trends in healthcare innovation and investment opportunities.

Sources

1. U.S. Food and Drug Administration. "FDA Approval Letter for DEFINITY," accessed via FDA.gov, 2001.
2. Lantheus Medical Imaging. "Annual Report 2023," available on Lantheus.com.
3. Grand View Research. "Contrast Media Market Analysis Report," 2023 edition.