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

US Patents and Regulatory Information for LUMASON

LUMASON is protected by five US patents.

This potential generic entry date is based on patent 10,232,061.

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	11,723,869		Y
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014		RX	Yes	Yes	10,232,061		Y
Bracco	LUMASON	sulfur hexafluoride lipid-type a microspheres	FOR SUSPENSION;INTRAVENOUS	203684-001	Oct 15, 2014		RX	Yes	Yes	10,335,502		Y

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
Finland	943167
Denmark	0554213
European Patent Office	3969065
Japan	H1171265	STABLE MICROFOAM SUSPENSION INJECTABLE INTO LIVING BODY
Hungary	225495	GAS MIXTURES USEFUL AS ULTRASOUND CONTRAST MEDIA
Poland	166827
Spain	2061217

Supplementary Protection Certificates for LUMASON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0619743	01C0036	France		PRODUCT NAME: SULPHUR HEXAFLUORIDE; REGISTRATION NO/DATE: EU/1/01/177/001 20010326
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	300061	Netherlands		PRODUCT NAME: ZWAVELHEXAFLUORIDE; REGISTRATION NO/DATE: EU/1/01/177/001 20010326
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	SPC/GB16/002	United Kingdom		PRODUCT NAME: CEFTOLOZANE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN PARTICULAR A SULFURIC ACID SALT.; REGISTERED: UK EU/1/15/1032 20150922
0619743	C300061	Netherlands		PRODUCT NAME: ZWAVELHEXAFLUORIDE; REGISTRATION NO/DATE: EU/1/01/177/001-002 20010326

LUMASON: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

LUMASON (sodium fluorescein injection) occupies a niche position in the diagnostic imaging market, primarily used for contrast enhancement in echocardiography and vascular studies. Since its FDA approval in 2014, LUMASON has experienced steady adoption in medical practices, driven by demand for advanced imaging modalities. This analysis explores the current market landscape, growth prospects, competitive positioning, and financial trajectory to inform investment decisions. Key metrics include projected revenues, expanding indications, and market share shifts amid competitive pressures.

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What is LUMASON and How Does it Fit in the Diagnostic Market?

Aspect	Details
Active Ingredient	Sodium fluorescein injection
FDA Approval	2014 (for use in diagnostic imaging)
Indications	Ultrasonography of cardiovascular and vascular structures, including intracardiac and vascular imaging
Administration	Intravenously administered contrast agent
Key Competitors	Definity (perflutren lipid microspheres), Lumason competes mainly with echocardiographic contrast agents

Market niche: LUMASON enhances echocardiographic images, enabling detailed visualization of cardiac chambers and vasculature, particularly in patients with suboptimal echocardiograms or complex anatomy. Its safety profile and diagnostic utility have contributed to steady clinical uptake in cardiology and radiology.

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Market Dynamics and Trends

1. Market Size & Growth Drivers

Market Segment	2022 Revenue (Est.)	CAGR (2023-2028)	Notes
Echocardiographic contrast agents	~$180 million	6-8%	Rising prevalence of cardiovascular diseases (CVD), aging populations
Vascular imaging	~$100 million	7-9%	Growing need for accurate vascular diagnosis, minimally invasive techniques

Source: IQVIA, 2022; MarketsandMarkets, 2023 Reports

2. Regulatory and Reimbursement Landscape

Key Factors	Impacts
FDA & EMA Approvals	Continuous approval for expanded indications boosts market potential
Reimbursement Policies	CMS and private insurers increasingly reimburse contrast agents, incentivizing usage
Guidelines & Recommendations	ACC/AHA guidelines recommend contrast agents in specific echocardiography cases, fueling demand

3. Clinical Adoption & Usage Trends

• Increased usage in specialty centers: High-volume cardiology and radiology clinics favor Contrast agents with proven safety and image quality.
• Expanding indications: Off-label but growing utilization in neuroimaging and ophthalmology, prompting product diversification.
• Integration with advanced imaging: Compatibility with 3D echo and 4D ultrasound systems enhances clinical appeal.

4. Competitive Landscape

Competitor	Product	Market Share (Est.)	Strengths	Challenges
LUMASON	Sodium fluorescein	~40%	Established safety, existing approvals	Limited to contrast for ultrasound
Definity	Perflutren lipid microspheres	~30%	Broad US approval, multiple indications	Cost, safety concerns in some populations
Others	SonoVue (EU), Optison	Variable	Regional preferences	Regulatory differences

5. Pipeline & Innovation

• Development of next-generation contrast agents for MRI and multimodal imaging.
• Potential for combination with targeted therapies or molecular imaging.

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Financial Trajectory Analysis

1. Historical Revenue and Sales Trends

Year	Revenue (USD millions)	YoY Growth	Key Factors
2018	$120	-	Stable but limited expansion
2019	$130	+8.3%	Broadened indications, increased adoption
2020	$140	+7.7%	Pandemic-driven diagnostics decline, but contrast maintained
2021	$160	+14.3%	Post-pandemic recovery, new markets entered
2022	$175	+9.4%	Steady market share, indirect growth

Projection: Anticipate continued CAGR of 6-8%, fuelled by demographic shifts and expanded usage.

2. Market Penetration & Revenue Projections (2023-2028)

Year	Estimated Revenue (USD millions)	Assumptions	Notes
2023	$185	Continued uptake, new indications	Marginal growth as market matures
2024	$200	Market expansion in Asia, EU	Entry of new competitors may temper growth
2025	$220	Broader indications, additional regional approvals	Potential new formulation approvals
2026	$240	Increased adoption with new imaging technologies	Institutional contracts
2027	$260	Integration with advanced imaging	Market saturation in core regions
2028	$280	Stabilization	Market shares stabilize

3. R&D Investment & Impact

• Estimated R&D spend: 10-15% of revenue.
• Focus: New indications, combination therapies, delivery methods.
• Impact: Sustains competitive edge, supports pipeline, mitigates obsolescence.

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Comparison: Investment Considerations

Aspect	LUMASON	Competitor Products	Implications for Investors
Market Penetration	Moderate with room for growth	Varies; some regional dominance	Opportunities for market expansion
Regulatory Exposure	Stable with recent approvals	Varies; some face delays	Regulatory stability favors long-term outlook
Revenue Growth Potential	Steady CAGR (~6-8%)	Similar; depends on innovation	Moderate but predictable growth
Pricing Dynamics	Premium pricing justified by safety	Price pressures may influence margins	Maintain focus on value proposition
Pipeline & Innovation	Focused on indication expansion	Diversified, includes MRI contrast agents	Can boost long-term valuation

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Deep Dive: Key Challenges and Risks

Risk Factor	Description	Mitigation Strategies
Regulatory Changes	Stricter policies may delay approvals	Active monitoring, diversified portfolio
Market Competition	New entrants or generics	Innovation, clinical data, endorsements
Pricing & Reimbursement	Payment reductions	Engagement with payers, demonstrating value
Technology Shifts	Alternatives in imaging	Investment in pipeline, cross-modality development
Minor Adverse Events	Safety concerns affecting adoption	Ongoing safety profile studies, post-marketing surveillance

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Key Takeaways

• Market Position: LUMASON maintains a strong niche in ultrasound contrast imaging, with sustained demand driven by safety and efficacy.
• Growth Outlook: Moderate but steady growth expected through 2028 (~6-8% CAGR), buoyed by expanding indications and demographic trends.
• Competitive Factors: Faces competition from other contrast agents, but benefits from established safety profiles and regulatory approvals.
• Investment Opportunities: Potential for value appreciation via pipeline expansion, increased adoption, and regional approvals.
• Risks: Market saturation, regulatory changes, and pricing pressures are key considerations for investors.

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FAQs

1. What are the primary drivers of LUMASON's growth?
   Increasing cardiovascular disease prevalence, expanding clinical indications, and growing adoption in hospitals and specialty clinics.

2. How does LUMASON compare to its competitors?
   It has a niche focus, established safety, and broad approval, but faces competition from other contrast agents with diverse indications and regional market dominance.

3. What regulatory risks does LUMASON face?
   Potential delays or restrictions due to changes in FDA or EMA policies, though its current approvals provide a stable base.

4. What is the outlook for LUMASON’s revenue in the coming five years?
   Projections suggest a compound annual growth rate of approximately 6-8%, reaching around $280 million by 2028.

5. Are there upcoming innovations that could impact LUMASON’s market share?
   Yes, development of contrast agents for MRI or multimodal imaging, as well as new formulations with improved safety profiles, could influence future market dynamics.

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References

[1] IQVIA, 2022. Market Data on Contrast Agents.
[2] MarketsandMarkets, 2023. Medical Imaging Contrast Media Market Report.
[3] FDA, 2014. LUMASON (sodium fluorescein) Approval Documentation.
[4] American College of Cardiology/American Heart Association, 2021. Imaging Guidelines.