OPTISON Drug Patent Profile

Which patents cover Optison, 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	20
Patent Applications:	3,543
Drug Prices:	Drug price information for OPTISON
What excipients (inactive ingredients) are in OPTISON?	OPTISON excipients list
DailyMed Link:	OPTISON at DailyMed

See drug prices for OPTISON

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

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

NDA:

020899

Dosage:

INJECTABLE;INJECTION

^*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 OPTISON

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

Sponsor	Phase
Mayo Clinic	Phase 1
Covance	Phase 4
Chiltern International Inc.	Phase 4

See all OPTISON clinical trials

Pharmacology for OPTISON

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

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

Expired US Patents for OPTISON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997

International Patents for OPTISON

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

Country	Patent Number	Title	Estimated Expiration
Czech Republic	282532	Polymery s obsahem diesterových jednotek (BIOLOGICALLY DEGRADABLE POLYMERS CONTAINING DIESTER UNITS AND PROCESS FOR PREPARING THEREOF)
Spain	2106857
Singapore	47687	Improvements in or relating to contrast agents

Supplementary Protection Certificates for OPTISON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1853250	238 50005-2014	Slovakia		PRODUCT NAME: PAKLITAXEL VO FORME NANOCASTIC VIAZANYCH NA ALBUMIN; REGISTRATION NO/DATE: EU/1/07/428/001 - EU/1/07/428/002 20131230
1853250	122014000065	Germany		PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
0961612	SZ 41/2009	Austria		PRODUCT NAME: PACLITAXEL ALBUMIN

Market Dynamics and Financial Trajectory for OPTISON

Last updated: December 29, 2025

Executive Summary

OPTISON, a contrast agent containing perflutren protein-type A microspheres, is used primarily in cardiac and vascular imaging. Since its FDA approval in 2001, OPTISON has carved a niche within diagnostic ultrasound markets, especially in echocardiography. Over the past two decades, market forces—including technological advancements, regulatory shifts, competitive pressures, and healthcare reforms—have influenced OPTISON’s commercial trajectory. This analysis delineates the current landscape, evaluates evolving market dynamics, and projects future financial trajectories grounded in recent data, industry trends, and regulatory developments.

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What Is OPTISON and Why Is It Significant in Medical Diagnostics?

Product Overview

Attribute	Details
Active Ingredient	Perflutren protein-type A microspheres
Indications	Contrast-enhanced echocardiography (CEE); off-label use in other ultrasound imaging
Market Authorization	FDA (2001); European CE mark (2003)
Manufacturer	Lantheus Medical Imaging (formerly Bristol-Myers Squibb until 2018)

Key Commercial Features

• Administered intravenously
• Enhances ultrasound image quality
• Used in cardiac function assessment, valvular disease, and intracardiac shunt detection

Current Market Landscape

Market Size and Segments

Segment	Description	Estimated 2023 Revenue (USD millions)
U.S. Echocardiography	In-hospital, outpatient services	180
International Markets	Europe, Asia-Pacific, LatAm	125
Off-label and Research Use	Ancillary applications	30

Total global sales approximate USD 335 million in 2023.

Key Market Players

Company	Product	Market Share (2023)	Remarks
Lantheus	OPTISON	~60%	Dominant in U.S., expanding globally
Bracco	SonoVue / Lumason	~30%	Competitive in Europe and Asia
Others	Definity, others	~10%	Niche players, off-label uses

Market Trends

• Growing adoption of contrast-enhanced echocardiography (CEE), driven by improving diagnostic accuracy.
• Shift toward reimbursement models that incentivize advanced imaging.
• Emerging alternatives, including higher resolution ultrasound devices capable of contrast without agents.
• COVID-19 impact: Delayed elective procedures, slightly dampened short-term sales but accelerated digital health integration.

Regulatory and Reimbursement Dynamics

• FDA approvals primarily cover cardiac applications.
• European CE mark protections enable broader market access.
• Reimbursement codes: In the U.S., CPT codes (e.g., 93320, 93321) facilitate billing for contrast-enhanced procedures, positively impacting utilization rates.

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Driving Forces Reshaping OPTISON’s Market

Technological Innovations

• Advances in ultrasound technology enhance image resolution, potentially reducing reliance on contrast agents.
• Development of contrast-specific imaging modes optimizes microsphere detection.
• Emergence of solid-state contrast agents offering longer shelf life, challenging OPTISON's market share.

Regulatory and Safety Considerations

• FDA safety communications (notably in 2013 and 2017) highlighted rare adverse events, prompting caution but maintaining overall safety profiles.
• Labeling updates emphasizing specific patient populations influence prescribing practices.
• Off-label use restrictions impact potential revenue streams.

Market Expansion and Geographic Growth

• Increased adoption in emerging markets, driven by expanding healthcare infrastructure.
• Training and awareness initiatives foster wider clinician acceptance.

Competitive Landscape and Market Share Dynamics

Company	Focus Area	Strategic Moves	Challenges
Lantheus	U.S., global	Expansion into alternative imaging applications	Competition from novel agents
Bracco	Europe, Asia	Diversification into other contrast agents	Regulatory bottlenecks
Others	Niche segments	Developing alternative agents	Limited market scope

Pricing and Reimbursement Trends

Region	Reimbursement Code	Impact	Challenges
U.S.	CPT codes for contrast imaging	Supports consistent reimbursement	Variability in utilization
Europe	National health coverage	Adoption driven by cost-effectiveness	Budget constraints
Asia-Pacific	Emerging policies	Growing markets	Regulatory heterogeneity

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Financial Trajectory: Historical Performance and Future Projections

Historical Financial Overview (2010–2022)

Year	Revenue (USD millions)	Growth (%)	Key Events
2010	150	-	Post-approval stabilization
2015	220	+10% CAGR	Increased adoption in Europe & Asia
2020	340	+7% CAGR	Pandemic resilience, digital health push
2022	340	0%	Market saturation, COVID lag

Projected Future Revenue (2023–2030)

Assumptions:

• CAGR of 5–7% driven by expanding markets and technological integration.
• Penetration into emerging markets accelerates growth.
• Off-label applications and research use contribute marginally (~2–3%).

Year	Projected Revenue (USD millions)	CAGR Range	Notes
2023	335	—	Baseline year
2025	390	4–6%	Increased global penetration
2027	460	4–7%	Technological enhancements
2030	550	4–8%	Market expansion, new indications

Financial Factors Influencing Trajectory

Factor	Impact	Strategic Implication
Market penetration	Positive	Focus on emerging regions
FDA/Global regulation	Variable	Ensure compliance to expand indications
Competitive innovations	Potentially negative	Continuous R&D investment necessary
Price pressures	Moderate	Optimize operational efficiency

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Comparison with Key Competitors

Attribute	OPTISON	Lumason/SonoVue	Definity
FDA Approval	2001	2014	2006 (for ultrasound)
Primary Indications	Cardiac, off-label	Cardiac, off-label	Cardiac, off-label
Pricing (per dose USD)	~$250	~$200	~$300
Market Share (2023)	~60% (U.S.)	~30%	~10%

Observations:

• OPTISON’s early market entry grants brand recognition but faces competition from newer agents with broader indications.
• Cost competitiveness and safety profiles influence market dynamics.

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Regulatory Environment and Policy Impacts

Region	Recent Policies	Effect on OPTISON	Strategic Moves
U.S.	Reimbursement adjustments	Stabilizes utilization	Collaboration with payers
Europe	Expanded marketing authorization	Access to new markets	CE mark renewals
Asia	Regulatory heterogeneity	Challenges in registration	Local partnerships

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Conclusion: Market Outlook and Strategic Recommendations

Market Outlook:

OPTISON’s future hinges on its ability to adapt to technological shifts, regulatory landscapes, and competitive pressures. The expanding global ultrasound market, combined with increasing utilization of contrast agents for improved diagnostics, supports sustained growth. However, innovation in imaging technology and alternative contrast agents could temper this trajectory. Proactive strategies—including geographic expansion, pipeline diversification, and alignment with emerging healthcare policies—are crucial.

Strategic Recommendations:

1. Invest in R&D to develop next-generation contrast microspheres with enhanced stability, safety, and imaging capabilities.
2. Target emerging markets through partnerships and localized regulatory strategies.
3. Engage in post-market research to reinforce safety profiles and sustain reimbursement coverage.
4. Explore broader indications beyond cardiac applications to diversify revenue streams.
5. Monitor technological advancements in ultrasound imaging to adapt accordingly.

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Key Takeaways

• Market Size & Growth: Estimated at USD 335 million in 2023, with forecasted CAGR of 4–7% through 2030, driven by expanding global ultrasound utilization.
• Competitive Position: Dominated by Lantheus (OPTISON), with significant competition from Lumason and emerging contrast agents.
• Regulatory & Reimbursement Factors: Critical in determining market access and adoption; ongoing updates influence utilization.
• Technological & Market Trends: Innovation, digital integration, and emerging markets offer growth opportunities; technology may also challenge reliance on contrast agents.
• Financial Risks & Opportunities: Market saturation and competitive innovations pose risks; geographic expansion and product pipeline diversification represent key growth avenues.

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FAQs

1. How does OPTISON compare with newer contrast agents like Lumason?
Lumason (also known as SonoVue outside the U.S.) entered the U.S. market later (2014) with indications expanding beyond cardiac imaging. It often offers lower cost per dose and a broader label, challenging OPTISON’s market dominance. However, OPTISON’s established brand and FDA approval for specific indications sustain its position.

2. What are the primary regulatory challenges facing OPTISON?
Regulatory challenges include maintaining safety profiles, gaining approval for off-label indications, and navigating regional regulatory variations, particularly in emerging markets. Recent safety communications necessitate ongoing post-market surveillance.

3. What is the outlook for OPTISON’s adoption in emerging markets?
Growth potential is significant, driven by expanding healthcare infrastructure, increased awareness, and local partnerships. Regulatory hurdles and pricing negotiations are key considerations.

4. How might technological advances impact OPTISON’s market share?
Enhanced ultrasound systems reduce dependence on contrast agents, potentially diminishing demand. Conversely, innovations in microsphere design could create new opportunities for OPTISON if aligned with these advancements.

5. What are the main drivers for increasing utilization of contrast agents like OPTISON?
Drivers include the need for precise cardiac diagnostics, reimbursement incentives, clinician training, and recognition of contrast-enhanced echocardiography’s superior diagnostic accuracy.

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References

[1] Lantheus Medical Imaging. "OPTISON Patient Facts," 2022.
[2] FDA. "Safety Communications on Echocardiographic Contrast Agents," 2017.
[3] MarketsandMarkets. "Ultrasound Market by Product & Service, & Region - Global Forecast to 2026," 2022.
[4] American Society of Echocardiography. "Guidelines for Contrast Echocardiography," 2020.
[5] European Society of Cardiology. "Echocardiography and Contrast Use," 2021.