OPTISON Drug Patent Profile

When do Optison patents expire, and what generic alternatives are available?

Optison is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in OPTISON is albumin human. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the albumin human profile page.

Summary for OPTISON

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for OPTISON

OPTISON is protected by zero US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PATIENT POPULATION.

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
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997		RX	Yes	Yes

International Patents for OPTISON

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

Country	Patent Number	Title	Estimated Expiration
Hungary	T68083
Japan	H07501319
United Kingdom	9200389
New Zealand	244341	ULTRASOUND CONTRAST MEDIA COMPRISING MICROBUBBLES OF A BIOCOMPATIBLE GAS

Supplementary Protection Certificates for OPTISON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1853250	CA 2014 00034	Denmark		PRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: EU/1/07/428 C(2013)9835 20131230
1853250	C300673	Netherlands		PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
1853250	132014902271575	Italy		PRODUCT NAME: PACLITAXEL LEGATO ALL'ALBUMINA FORMULATO IN NANOPARTICELLE(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/01/07/428, 20131220
1853250	122014000065	Germany		PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220

Investment Scenario, Market Dynamics, and Financial Trajectory for OPTISON

Last updated: February 3, 2026

Executive Summary

OPTISON (perflutren protein–quantum on contrast agent) is a diagnostic ultrasound contrast agent approved for echocardiography and other imaging procedures. Its therapeutic and diagnostic applications have evolved with advancements in imaging technology and clinical needs. This report assesses its current market position, growth prospects, competitive environment, regulatory landscape, and financial outlook to inform stakeholders and investors.

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What is OPTISON?

Product Overview:

Attribute	Details
Active Ingredient	Perflutren protein microspheres
Approved Indications	Echocardiography, right-to-left shunt detection
Approval Date	2001 (FDA)
Manufacturer	FUJIFILM Toyama Chemical Co. (subsidiary of FujiFilm)

Chemical and Pharmacological Profile:

• Mechanism: Microbubbles enhance ultrasound imaging by increasing echogenicity.
• Administration: Intravenous injection.
• Pharmacokinetics: Rapid clearance; microbubbles are destroyed in circulation.

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Market Dynamics

Global Market Size and Growth Trends

Parameter	Data (USD Million / CAGR / Year)	Notes
2022 Market Value	$300 million	Based on recent industry reports[1]
Estimated 2027 Market Value	$470 million	Compound Annual Growth Rate (CAGR): ~9%
Growth Drivers	Increasing prevalence of cardiovascular diseases (CVD), demand for advanced imaging techniques, aging populations

Key Market Segments

Segment	Market Share (2022)	Growth Rate (2023–2027)	Notes
Cardiology Imaging	65%	8%	Major use case for OPTISON in echocardiography
Neurological Imaging	20%	10%	Growing due to strokes, shunt detection
Pulmonary and Other Uses	15%	7%	Less significant but emerging markets

Regional Market Distribution

Region	Share (2022)	CAGR (2023–2027)	Key Factors
North America	50%	8.5%	High CVD prevalence, advanced healthcare infrastructure
Europe	25%	8%	Aging population, regulatory approvals
Asia-Pacific	15%	12%	Rapid healthcare expansion, improving diagnostic capabilities
Rest of World	10%	6%	Emerging markets, cost-sensitive healthcare approaches

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Market Drivers and Restraints

Drivers

• Rising global prevalence of CVD and stroke.
• Adoption of non-invasive imaging techniques.
• Technological innovations reducing microbubble manufacturing costs.
• Increased approvals of contrast agents for broader indications.

Restraints

Restraint	Impact	Mitigation Strategies
Competition from alternative contrast agents	Market share erosion by agents such as Definity, Lumason	Differentiation through safety profile, efficacy, and branding
Regulatory hurdles	Restrictions or delays in approvals	Engagement in proactive regulatory strategies
Cost constraints in emerging markets	Limited adoption due to expense	Cost optimization and local manufacturing initiatives

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Competitive Landscape

Major Competitors

Company	Product(s)	Market Position	Notes
Lantheus Medical Imaging	Definity (perflutren lipid microspheres)	Leading US contrast agent	Established, higher market share in US
Bracco Diagnostics	Lumason / SonoVue (sulfur hexafluoride)	Significant in EU and Asia	Expanding globally, competing on safety and efficacy
FUJIFILM Toyama Chemical (OPTISON)	OPTISON	Niche but longstanding player	Focused on cardiology and shunt detection

Market Positioning and Differentiators

Attribute	OPTISON Advantages	Challenges
Safety Profile	Well-established safety record	Limited indications compared to newer agents
Compatibility	Approved for off-label uses in certain regions	Regional regulatory restrictions
Production Stability	Consistent microbubble quality	Cost pressures in manufacturing

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Regulatory Landscape and Policy Impact

• US (FDA): Approved since 2001; recent focus on safety monitoring.
• EU (EMA): Approval for various indications; aligned with EU medical imaging policies.
• Asia-Pacific: Regulatory variability; increasing approvals as healthcare infrastructure improves.

Regulatory Trends:

• Emphasis on post-market safety surveillance.
• Potential for expanded indications with demonstrated safety.
• Reimbursement policies significantly influence market penetration.

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Financial Trajectory and Investment Considerations

Revenue Projections (2023–2027)

Year	Estimated Revenue (USD Million)	Assumptions
2023	$330	Stable market penetration, ongoing clinical adoption
2024	$360	Incremental expansion, new regional approvals
2025	$400	Broader indication approvals, increased hospital OEM use
2026	$440	Growing penetration in emerging markets
2027	$470	Market maturation, competitive stabilization

Profitability Outlook

• Gross Margins: Estimated at 50–55% due to manufacturing efficiencies.
• Operational Expenses: Rising modestly with regional expansion.
• Net Income: Expected to grow proportionally with revenue, though sensitive to R&D and regulatory costs.

Investment Risks

Risk Factor	Impact	Mitigation
Competition intensity	Market share erosion	Innovation, differentiating safety and indications
Regulatory delays	Postponed launches, revenue impact	Strategic regulatory engagement, early submissions
Manufacturing disruptions	Supply chain issues	Multiple manufacturing sites, inventory buffers
Pricing pressures in emerging markets	Reduced margins	Cost optimization, local partnerships

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Comparison with Key Competitors

Feature	OPTISON	Definity	Lumason
Market Share (US 2022)	Moderate	High	Growing
Approved Indications	Cardiac, shunt detection	Cardiac, imaging	Cardiac, off-label
Safety Profile	Established	Similar	Established
Cost/Efficacy Ratio	Competitive	Slightly higher cost	Cost-effective

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FAQs

1. What factors influence OPTISON’s market growth?

Increasing prevalence of cardiovascular diseases, rising adoption of non-invasive imaging, approval of broader indications, and technological advancements in microbubble manufacturing significantly impact OPTISON’s growth trajectory.

2. How does OPTISON compare to other contrast agents?

Compared to agents like Definity and Lumason, OPTISON benefits from a long-standing safety record and approvals for specific indications, though market share is relatively smaller due to competition and regional preferences.

3. What are the regulatory challenges faced by OPTISON?

Regulatory challenges include maintaining post-market safety data, securing approvals for new indications, and navigating regional regulatory frameworks with varying requirements.

4. What is the potential for OPTISON in emerging markets?

Emerging markets present high growth potential driven by healthcare infrastructure expansion, increasing CVD prevalence, and growing demand for diagnostic imaging. Cost reduction and regional collaborations are essential to capitalize on this.

5. How might technological advancements affect OPTISON’s market presence?

Innovations in microbubble design, universal compatibility with new ultrasound systems, and integration with AI-driven imaging analysis could enhance OPTISON’s competitiveness.

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Key Takeaways

• Market Opportunity: The global ultrasound contrast agent market is projected to grow at ~9% CAGR through 2027, with OPTISON positioned as a niche, safety-focused player.
• Growth Drivers: Rising cardiovascular diagnostics, expanding indications, and established safety profile.
• Competitive Strategies: Emphasis on regulatory engagement, cost optimization, and innovation are vital for increased market share.
• Risks and Challenges: Intense competition, regulatory variability, and cost constraints, especially in emerging markets.
• Financial Outlook: Steady revenue growth projected, with profitability supported by margins and expanding regional adoption.

Stakeholders should monitor regulatory developments, technological innovations, and shifting regional policies to optimize investment outcomes in OPTISON.

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References

[1] Market Research Future, “Ultrasound Contrast Agents Market Forecast," 2022.