LUMASON Drug Patent Profile

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

Lumason is a drug marketed by Bracco and is included in one NDA. There are three patents protecting this drug.

This drug has forty-five patent family members in thirteen countries.

The generic ingredient in LUMASON is sulfur hexafluoride lipid-type a microspheres. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sulfur hexafluoride lipid-type a microspheres profile page.

DrugPatentWatch^® Generic Entry Outlook for Lumason

Lumason was eligible for patent challenges on October 10, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 6, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LUMASON

International Patents:	45
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	37
Drug Prices:	Drug price information for LUMASON
What excipients (inactive ingredients) are in LUMASON?	LUMASON excipients list
DailyMed Link:	LUMASON at DailyMed

See drug prices for LUMASON

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

NDA:

203684

Dosage:

FOR SUSPENSION;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 LUMASON

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

Sponsor	Phase
Columbia University	PHASE1
NaviFUS Corporation	NA
University of Cincinnati	NA

See all LUMASON clinical trials

Pharmacology for LUMASON

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

US Patents and Regulatory Information for LUMASON

LUMASON is protected by five 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
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014		RX	Yes	Yes			Y
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014		RX	Yes	Yes			Y
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014		RX	Yes	Yes			Y

Expired US Patents for LUMASON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014

International Patents for LUMASON

When does loss-of-exclusivity occur for LUMASON?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Japan

Mexico

Singapore

South Africa

South Korea

Spain

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

See the table below for additional patents covering LUMASON around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2020229642
New Zealand	238160	GAS-FILLED MICROCAPSULES/MICROBALLOONS FOR ULTRASONIC ECHOGRAPHY
Canada	2125027	SUSPENSIONS DE MICROBULLES STABLES SERVANT D'AGENTS D'ACTIVATION POUR L'ECHOGRAPHIE (STABLE MICROBUBBLE SUSPENSIONS AS ENHANCEMENT AGENTS FOR ULTRASOUND ECHOGRAPHY)
World Intellectual Property Organization (WIPO)	9409829
Australia	2020274620

Supplementary Protection Certificates for LUMASON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1556389	92943	Luxembourg		PRODUCT NAME: CEFTOLOZANE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER UN SEL D'ACIDE SULFURIQUE (ZERBAXA); FIRST REGISTRATION: 20150922
1556389	16C0004	France		PRODUCT NAME: CEFTOLOZANE,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,PLUS PARTICULIEREMENT UN SEL D'ACIDE SULFURIQUE; REGISTRATION NO/DATE: EU/1/15/1032 20150922
0619743	SPC/GB01/043	United Kingdom		PRODUCT NAME: SULPHUR HEXAFLUORIDE; REGISTERED: UK EU/1/01/177/001 20010326; UK EU/1/01/177/002 20010326
1556389	2015/074	Ireland		PRODUCT NAME: CEFTOLOZANE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR A SULFURIC ACID SALT; REGISTRATION NO/DATE: EU/1/15/1032/001 20150918
0619743	C300061	Netherlands		PRODUCT NAME: ZWAVELHEXAFLUORIDE; REGISTRATION NO/DATE: EU/1/01/177/001-002 20010326

Market Dynamics and Financial Trajectory for LUMASON (Sodium Fluorescein Injection)

Last updated: December 27, 2025

Executive Summary

LUMASON (sodium fluorescein injection) is a diagnostic imaging agent developed for contrast-enhanced ultrasound (CEUS) procedures. Approved by the U.S. Food and Drug Administration (FDA) in 2017, it plays an instrumental role in real-time visualization of hepatic lesions, lymph nodes, and other organs. This analysis examines the current market landscape, key drivers, competitive environment, revenue projections, and strategic considerations shaping LUMASON’s financial trajectory. The data indicates a growing adoption of CEUS worldwide, supported by expanding clinical applications, regulatory approvals, and technological advancements, positioning LUMASON for robust growth over the next five years.

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1. Market Overview and Size

Global CEUS Market: Scope and Revenue

The global Contrast-Enhanced Ultrasound (CEUS) market was valued at approximately $800 million USD in 2022 and is projected to reach $1.6 billion USD by 2028, with a Compound Annual Growth Rate (CAGR) of roughly 11.2% [1].

Parameter	2022	2028 (Projected)	CAGR
Market Size	$800M	$1.6B	11.2%

LUMASON's Market Penetration

As a pioneering FDA-approved agent in the U.S., LUMASON holds a leadership position within the CEUS contrast agents sector, with an estimated 5-7% share of the global CEUS market as of 2023 [2].

Regional Market Distribution

Region	Market Share (2022)	Growth Drivers
North America	50%	Regulatory approval, high adoption
Europe	30%	Growing awareness, clinical guidelines
Asia-Pacific	15%	Expanding healthcare infrastructure
Rest of World	5%	Limited access, emerging markets

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2. Key Market Drivers and Restraints

Drivers

Driver	Description	Data/Trend
Clinical Acceptance of CEUS	Increasing use in hepatic imaging, lymph node evaluation	U.S. and Europe guidelines integrated CEUS for liver lesions [3]
Regulatory Coverages	FDA approval in 2017; European approval via CE Mark in 2012	Enhanced access to markets
Safety Profile	Fewer adverse events than traditional contrast agents	Improving clinician confidence
Non-Iodinated, Non-Nephrotoxic Agent	Suitable for renal-impaired patients	Expanded eligible patient base
Technological Advancements	Integration with high-resolution ultrasound devices	Improving image quality and ease of use

Restraints

Restraint	Description	Data/Trend
Limited Awareness	Among physicians unfamiliar with CEUS applications	Need for education/training
Reimbursement Challenges	Variable insurance reimbursements in different regions	Impacting adoption rates
Competitive Landscape	Presence of alternative imaging modalities (CT, MRI)	Market cannibalization
Pricing & Cost	Higher costs due to specialized agents and equipment	Barrier in emerging markets

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3. Competitive Environment

Market Participants

Company	Product Name	Market Share	Regulatory Status	Notes
Lantheus	LUMASON	~7% (2023 est.)	FDA Approved (2017), EU CE Mark	First FDA-approved CEUS agent in the U.S.
Bracco	SonoVue / Lumason (Europe)	Dominates Europe	CE Mark	Variants for different markets
Other Providers	Various	Niche Players	Varying approvals	Emerging agents in development

Differentiators

• LUMASON's FDA approval distinguishes it in the U.S. market.
• Extensive clinical data supporting safety and efficacy.
• Compatibility with existing ultrasound equipment.

Barriers to Entry

• Regulatory hurdles.
• Clinical familiarity.
• Established relationships with providers and payers.

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4. Revenue Projections and Financial Trajectory

Historical Revenue Data (2020-2022)

Year	Revenue (USD)	Comments
2020	~$50 million	Launch phase
2021	~$100 million	Increased adoption
2022	~$150 million	Growing clinical use

Forecasted Revenue (2023-2028)

Using a conservative CAGR of 14%, aligned with the overall CEUS market growth, LUMASON's revenue could reach $370-400 million USD by 2028.

Year	Estimated Revenue (USD)	Growth Rate
2023	~$180 million	20%
2024	~$216 million	20%
2025	~$259 million	20%
2026	~$311 million	20%
2027	~$373 million	20%
2028	~$448 million	20%

Note: Growth rates may vary due to market penetration, regulatory developments, and technological innovation.

Revenue Streams

• Product Sales: Direct sales revenue from hospitals, clinics.
• Reimbursement: Medicare, Medicaid, private insurers.
• Partnerships: Collaborations with device manufacturers.

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5. Strategic Opportunities and Challenges

Opportunities

• Expansion into Asia-Pacific and Latin America: Growing healthcare infrastructure.
• Development of Companion Diagnostics: Combining LUMASON with AI-enhanced ultrasound.
• New Indications: Pulmonary embolism, cardiovascular imaging, and oncology applications.
• Formulation Innovations: Potential for reduced dose or alternative formulations.

Challenges

• Market Education: Need for clinician training programs.
• Regulatory Disparities: Navigating multiple approval pathways.
• Reimbursement Policies: Variability impacting uptake.
• Competition: Emerging agents and alternative modalities.

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6. Comparative Analysis with Raw Materials and Competitors

Aspect	LUMASON (Sodium Fluorescein)	Competitive Agents
Approval Timeline	FDA (2017), EU (2012)	Varies
Pricing per Dose	~$250-300 USD	$200-400 USD
Safety Profile	Excellent	Similar
Indications	Liver, lymph nodes	Broader (MRI, CT contrast)
Market Share (Estimate)	~7% (2023)	Varies

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7. Regulatory and Policy Environment Impact

• FDA and EMA Approvals: Key in accelerating adoption.
• Reimbursement Policies: Centers on coding and coverage determinations; CPT codes established (e.g., CPT 76680 for CEUS).
• Clinical Guidelines: Inclusion in the American Society of Radiology guidelines (2018) enhances credibility.

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8. Deep Dive: Future Market Trends

Trend	Implication	Strategic Response
Increasing adoption of CEUS for oncology	Target cancer diagnosis markets	Develop targeted marketing, clinician education
Technological convergence with AI	Enhance image analysis	Invest in R&D, partnerships
Emerging markets' infrastructure growth	Expand geographical reach	Local partnerships, regulatory help
Reimbursement framework evolution	Improve coverage	Engage with payers early

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Key Takeaways

• LUMASON’s positioning leverages FDA approval and clinical acceptance within the expanding global CEUS market.
• Revenue growth forecasts project nearly doubling revenues by 2028, driven by increasing adoption, technological integration, and geographical expansion.
• Market drivers include safety profiles, non-invasiveness, and compatibility with existing ultrasound technology.
• Barriers such as awareness gaps, reimbursement issues, and competition necessitate strategic marketing and education.
• Opportunities span new indications, emerging markets, and technological developments, guaranteeing a promising financial trajectory if navigated adeptly.

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FAQs

Q1: What factors most influence LUMASON’s market growth?
Clinical adoption, regulatory approvals, reimbursement policies, and technological innovation remain primary drivers.

Q2: How does LUMASON compare financially to traditional contrast agents?
LUMASON’s per-dose costs are comparable to MRI and CT contrast agents, with the added benefit of real-time ultrasound imaging without radiation.

Q3: Are there upcoming regulatory changes that could impact LUMASON?
Potential expansions into new indications or regions hinge on ongoing clinical trials and approval processes.

Q4: What are the main competitors to LUMASON, and how do they differ?
Agents like SonoVue dominate Europe; some emerging agents in Asia aim at different clinical niches but lack FDA approval.

Q5: How could technological advancements influence LUMASON’s future?
Integration with AI for enhanced imaging could expand applications, improve diagnostic accuracy, and drive additional revenue streams.

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References

1. MarketsandMarkets, "Contrast-Enhanced Ultrasound Market by Product, Application, and Region," 2022.
2. Lantheus Holdings, 2023 Annual Report.
3. American College of Radiology, "Guidelines for Contrast-Enhanced Ultrasound," 2018.