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	5,529,766
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997	6,723,303
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997	5,573,751
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997	5,558,094

International Patents for OPTISON

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

Country	Patent Number	Title	Estimated Expiration
Bulgaria	61268
Japan	H07501319
African Intellectual Property Organization (OAPI)	10052	Polymers containing diester units
Norway	940956
Canada	2107106
Poland	173817
Philippines	31064	Polymers containing diester units.

Supplementary Protection Certificates for OPTISON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1853250	2014C/037	Belgium		PRODUCT NAME: PACLITAXEL DANS UNE FORMULATION DE NANOPARTICULE LIEES A L'ALBUMINE; AUTHORISATION NUMBER AND DATE: EU/1/07/428 20131230
0961612	300417	Netherlands		PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080114
0961612	C00961612/01	Switzerland		PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014
0961612	SZ 41/2009	Austria		PRODUCT NAME: PACLITAXEL ALBUMIN
1853250	37/2014	Austria		PRODUCT NAME: PACLITAXEL, DAS ALS ALBUMIN GEBUNDENE NANOPARTIKEL FORMUIERT IST.; REGISTRATION NO/DATE: EU/1/07/428 (MITTEILUNG) (GEAENDERT DURCH C(2013) 9835) 20131230
1853250	300673	Netherlands		PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
1853250	C300673	Netherlands		PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220

Market Dynamics and Financial Trajectory for Optison

Last updated: July 27, 2025

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Introduction

Optison (brand name), a contrast agent used in echocardiography, has established its footprint within the diagnostic imaging market. Its primary constituents—perflutren protein-type A microspheres—facilitate enhanced ultrasound imaging of the heart and vascular system. As advancements in cardiovascular diagnostics accelerate, understanding Optison’s market landscape, growth drivers, and financial trajectory becomes vital for stakeholders aiming to capitalize on emerging opportunities or mitigate risks.

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Market Overview

Optison is categorized under ultrasound contrast agents, a segment experiencing rapid growth driven by increasing prevalence of cardiovascular diseases (CVD), technological innovations in imaging, and expanding clinical applications.

Globally, the ultrasound contrast agents market was valued at approximately USD 674 million in 2021 and is projected to grow at a CAGR of 7-8% through 2028 [1]. Optison, as a key player, benefits directly from this upward trend, especially in developed markets like North America and Europe, where diagnostic imaging becomes central to patient management.

In North America, the market dominance owes to high healthcare expenditure, technological adoption, and favorable reimbursement policies. Europe follows due to expanding clinical indications and government support. In emerging markets, growth potential exists but is tempered by economic and infrastructural constraints.

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Market Drivers

1. Rising Cardiovascular Disease (CVD) Incidence CVD remains the leading cause of mortality worldwide, with an estimated 17.9 million deaths annually [2]. This epidemiological trend directly stimulates demand for diagnostic tools, including ultrasound contrast agents like Optison.

2. Advancement in Imaging Technology Innovations such as dedicated contrast-specific imaging techniques have enhanced the sensitivity and specificity of echocardiography, thereby broadening Optison’s clinical utility. The development of contrast-enhanced ultrasound (CEUS) for visualizing myocardial perfusion and intracardiac shunts exemplifies this trend.

3. Expanding Clinical Indications Initially limited to cardiac imaging, Optison's applications now extend into tumor imaging, perfusion assessment, and vascular diagnostics, attracting broader clinical adoption.

4. Rising Preference for Non-Invasive Diagnostics Clinicians favor non-invasive methods due to reduced risk and patient comfort, amplifying demand for contrast-enhanced ultrasound procedures where Optison is integral.

5. Reimbursement Policies In countries like the US and Europe, improved reimbursement rates for contrast-enhanced ultrasound procedures bolster market growth.

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Market Challenges

1. Competition and Patent Expiry While Optison benefits from existing approvals, generic alternatives or competing contrast agents—such as Lumason (sulfur hexafluoride microspheres)—erode market share.

2. Regulatory Hurdles Stringent approval processes, especially in emerging markets, restrict rapid market penetration.

3. Safety Concerns Although generally safe, rare adverse reactions to contrast agents, including allergic responses, influence clinician preferences and regulatory scrutiny.

4. Limited Awareness A lack of awareness among clinicians about ultrasound contrast applications hampers faster adoption, particularly outside cardiology.

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Regulatory and Reimbursement Environment

Optison’s market positioning hinges on regulatory approvals. The FDA approved Optison in 2004, maintaining a stronghold in the US market. Conversely, the European Medicines Agency (EMA) granted marketing authorization earlier, in 2001, bolstering its European footprint.

Reimbursement frameworks remain favorable in key markets but vary in emerging regions, impacting sales volumes. Value-based reimbursement models favor innovations that demonstrate improved diagnostic accuracy and patient outcomes, aligning with Optison’s benefits.

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Financial Trajectory and Revenue Projections

Historical Performance
While Serono, the original manufacturer, faced manufacturing challenges, the product was later acquired by Bracco Imaging in 2008. Post-acquisition, revenues have been relatively stable, with slight fluctuations influenced by regulatory approvals and competitive dynamics [3].

Recent Trends
In recent years, Optison’s sales have seen modest growth, primarily driven by clinical expansion and increasing procedural volumes. However, the advent of alternatives like Lumason has exerted pressure, limiting growth potential.

Projected Growth Drivers

• Market Expansion: Entry into new geographical regions where ultrasound contrast use is increasing.
• New Indications: Clinical trials exploring Optison’s efficacy in MRI compatibility or theranostic applications could unlock new revenue streams.
• Product Lifecycle Management: Re-certification and technological upgrades can sustain demand.

Forecasted Revenue Trajectory
Based on current market conditions and competitive landscape, Optison’s revenues are projected to grow at a conservative CAGR of 3-5% over the next five years. This reflects steady but cautious expansion, contingent on regulatory approvals, clinical adoption, and technological validation.

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Strategic Opportunities and Risks

Opportunities

• Developing markets’ burgeoning healthcare infrastructure offers room for growth.
• Expanding clinical validation studies can bolster clinician confidence.
• Potential integration with novel imaging modalities or combination therapies.

Risks

• Entrenchment of generic contrast agents and biosimilars.
• Regulatory delays in approval or market withdrawal.
• Reimbursement policy shifts reducing procedural profitability.

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Conclusion

Optison's market position remains stable within the evolving landscape of diagnostic imaging. Its growth trajectory depends heavily on expanding clinical applications, technological improvements, and regional market penetration strategies. While facing competitive pressures, periodic regulatory endorsements, and the overall thriving cardiovascular diagnostics market provide a foundation for moderate, sustained revenue growth.

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Key Takeaways

• The global ultrasound contrast agents market is poised for steady growth, favoring Optison’s continued relevance.
• Rising CVD prevalence and advances in echocardiographic technology serve as primary growth catalysts.
• Competition from newer agents and biosimilars constrains aggressive expansion, necessitating strategic product differentiation.
• Regulatory approval and reimbursement landscape significantly influence revenue trajectories.
• Opportunities exist in emerging markets, expanded indications, and technological integration, though risks require vigilant management.

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FAQs

Q1: What are the main clinical applications of Optison?
A1: Optison is primarily used in echocardiography to enhance imaging of the heart, including assessment of ventricular function, detection of intracardiac shunts, and perfusion imaging. Its utility extends to vascular and tumor imaging under CEUS techniques.

Q2: How does Optison compare to newer contrast agents like Lumason?
A2: Both are microbubble contrast agents used in ultrasound imaging. Lumason (sulfur hexafluoride) gained approval later, offering similar efficacy with potentially improved stability and different safety profiles. Market preference depends on regional approvals, clinician familiarity, and reimbursement policies.

Q3: What factors could impact Optison’s future revenue growth?
A3: Factors include increased competition from generic and branded alternatives, regulatory hurdles in new markets, safety profile perceptions, and shifts in reimbursement policies that affect procedure adoption.

Q4: Are there ongoing clinical trials to expand Optison’s indications?
A4: While specific trials are limited, ongoing research into contrast agents' applications in tumor characterization, myocardial perfusion, and theranostics could indirectly benefit Optison if validated and approved.

Q5: What strategic moves should stakeholders consider to maximize Optison’s market potential?
A5: Stakeholders should focus on market expansion into emerging regions, investing in clinical validation, engaging with regulatory agencies proactively, and exploring technological integrations that enhance imaging capabilities.

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References

[1] MarketsandMarkets, "Ultrasound Contrast Agents Market," 2022.
[2] World Health Organization, "Cardiovascular Diseases (CVDs)," 2021.
[3] Corporate filings and industry reports, 2022.