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
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)
Australia	679428
Hungary	221088	POLYMERS CONTAINING DIESTER UNITS AND PROCESS FOR PRODUCING THEREOF
South Africa	9107108
Canada	2119129	MILIEUX DE CONTRASTE GAZEUX POUR ULTRASONS ET METHODE DE SELECTION DE GAZ POUVANT ETRE UTILISES DANS CES MILIEUX (GASEOUS ULTRASOUND CONTRAST MEDIA AND METHOD FOR SELECTING GASES FOR USE AS ULTRASOUND CONTRAST MEDIA)

Supplementary Protection Certificates for OPTISON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0961612	CA 2009 00036	Denmark		PRODUCT NAME: PACLITAXELALBUMIN
0961612	300417	Netherlands		PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080114
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

OPTISON: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

Optison (perflutren lipid microsphere) is a diagnostic ultrasound contrast agent. Its market trajectory is shaped by demand for advanced imaging techniques in cardiology and radiology, coupled with its specific clinical applications and the competitive landscape.

What is the Current Market Size and Projected Growth for Optison?

The global market for ultrasound contrast agents, of which Optison is a component, was valued at approximately $750 million in 2022 [1]. Projections indicate a compound annual growth rate (CAGR) of 7.5% from 2023 to 2030, potentially reaching over $1.3 billion by the end of the forecast period [1]. This growth is primarily driven by the increasing prevalence of cardiovascular diseases, the rising adoption of minimally invasive diagnostic procedures, and technological advancements in ultrasound equipment that enhance image resolution and diagnostic accuracy.

What are the Key Clinical Applications Driving Optison Demand?

Optison is approved for specific diagnostic uses, primarily in echocardiography and contrast-enhanced ultrasound (CEUS) of the liver.

• Echocardiography: Optison is used to opacify the left ventricular chamber and to delineate the endocardial border in patients with suboptimal acoustic windows. This application is critical for assessing left ventricular function, wall motion abnormalities, and valvular heart disease, particularly in obese patients or those with lung disease [2].
• Liver Imaging: In contrast-enhanced ultrasound of the liver, Optison helps to characterize focal liver lesions, differentiating between benign and malignant masses. It aids in the detection of small lesions and provides enhanced vascular information, which is crucial for diagnosis and treatment planning [3].

The utility of Optison in improving diagnostic confidence in these areas directly influences its market penetration and sales volume.

Who are the Major Competitors in the Ultrasound Contrast Agent Market?

The ultrasound contrast agent market is competitive, with several established players and emerging technologies. Key competitors to Optison include:

• SonoVue (sulfur hexafluoride lipid microspheres): Developed by Bracco Imaging, SonoVue is a widely used contrast agent for CEUS of the liver and other organs. It offers broad applications and strong market presence in Europe and Asia.
• Lumason (sulfur hexafluoride lipid-type A microspheres): Manufactured by Bayer AG, Lumason is approved in the U.S. for contrast enhancement of B-mode ultrasound imaging in patients with suboptimal echocardiograms. It shares similar indications with Optison in cardiology.
• Definity (perflexane lipid microspheres): Also developed by Lantheus Medical Imaging (the manufacturer of Optison), Definity is another perfluorocarbon-based contrast agent used for contrast-enhanced echocardiography. Definity and Optison are direct competitors within Lantheus's own product portfolio, with Definity often cited as having a longer duration of contrast enhancement.

The competitive dynamics are influenced by product efficacy, safety profiles, regulatory approvals in different regions, pricing strategies, and established physician preference.

What is the Regulatory Status and Intellectual Property Landscape for Optison?

Optison is approved by the U.S. Food and Drug Administration (FDA) for specific indications in echocardiography and CEUS of the liver [2, 3]. Its regulatory journey involved clinical trials demonstrating safety and efficacy.

• FDA Approval Dates: Optison received its initial FDA approval in the U.S. in 1998 [4]. Subsequent approvals for expanded indications, such as for liver CEUS, were granted later.
• Patent Protection: Lantheus Medical Imaging holds patents related to the formulation and use of Optison. The patent landscape is crucial for protecting market exclusivity. Key patents covering the Optison formulation and manufacturing processes have expired or are nearing expiration. For instance, foundational patents for perflutren lipid microspheres have been in effect for many years. The expiry of primary patents opens the door for potential generic competition, although the complex manufacturing and regulatory hurdles for biosimilars or generics in this class can be significant. The current patent portfolio primarily focuses on method-of-use patents or specific formulation improvements, which can offer continued, albeit more limited, protection.

What is Lantheus Medical Imaging's Financial Performance Related to Optison?

Lantheus Medical Imaging's financial performance is a key indicator of Optison's market impact. While specific revenue breakdowns for Optison are often aggregated within broader product categories, its contribution can be inferred from overall diagnostics imaging segment performance.

• Revenue Contribution: Diagnostics imaging, which includes Optison and other contrast agents, has historically been a significant revenue driver for Lantheus. In the first quarter of 2023, Lantheus reported total net sales of $222.3 million, with its diagnostics business contributing substantially [5]. Optison's sales are influenced by its market share within the U.S. echocardiography and liver CEUS markets.
• Growth Drivers: Lantheus has focused on expanding the use of its contrast agents through physician education, targeted marketing, and partnerships. The growth of CEUS as a preferred imaging modality for liver lesion characterization is a positive factor for Optison.
• Impact of Competition: The presence of Lumason and Definity, along with international competitors like SonoVue, necessitates competitive pricing and ongoing innovation or market development efforts by Lantheus to maintain and grow Optison's market share.

What are the Future Market Trends and Potential Disruptors for Optison?

Several trends and potential disruptions will shape Optison's future market dynamics:

• Technological Advancements in Ultrasound: Newer ultrasound machines offer higher resolution, faster frame rates, and advanced imaging modes. Optison's performance is enhanced by these technological improvements, allowing for clearer visualization of microvasculature and cardiac function.
• Expansion of CEUS Applications: Research continues into new applications for CEUS, including in other organ systems (e.g., kidney, pancreas) and for new indications like assessing treatment response in oncology. Broader regulatory approvals for CEUS could significantly increase demand for contrast agents like Optison.
• Emergence of Alternative Imaging Modalities: While ultrasound offers distinct advantages in cost, portability, and radiation-free imaging, other modalities like MRI and CT scans also provide advanced diagnostic capabilities. The integration of artificial intelligence (AI) with these modalities could potentially impact demand for contrast agents if AI-driven image interpretation reduces the need for contrast enhancement in certain scenarios.
• Generic and Biosimilar Competition: As patents expire, the potential for generic or biosimilar versions of ultrasound contrast agents increases. While the manufacturing complexity of lipid microspheres may present barriers to entry, successful generic entrants could exert downward pressure on pricing and market share for established products.
• Value-Based Healthcare and Reimbursement Policies: Evolving reimbursement policies and a greater emphasis on value-based healthcare may influence the adoption of diagnostic tools and agents. Demonstrating cost-effectiveness and superior clinical outcomes will be critical for Optison's continued market success.

Key Takeaways

• Optison operates within a growing global ultrasound contrast agent market, driven by increasing cardiovascular disease prevalence and advancements in imaging technology.
• Its primary applications in echocardiography and liver CEUS are well-established, contributing to consistent demand.
• The competitive landscape includes established players like Bracco Imaging and Bayer AG, as well as Lantheus's own competing product, Definity.
• Lantheus Medical Imaging relies on its diagnostics segment, including Optison, for a significant portion of its revenue, necessitating strategic market management.
• Future market dynamics will be influenced by technological innovation in ultrasound, expansion of CEUS applications, and potential disruptions from alternative imaging modalities or generic competition.

Frequently Asked Questions

1. What specific heart conditions is Optison primarily used to diagnose? Optison is used in echocardiography to improve the visualization of the left ventricular chamber and endocardial border in patients with suboptimal acoustic windows, aiding in the diagnosis of conditions like reduced ejection fraction, regional wall motion abnormalities, and valvular regurgitation.

2. How does Optison improve the visualization of liver lesions? In contrast-enhanced ultrasound of the liver, Optison highlights blood flow within lesions. This enhanced vascularity pattern helps radiologists differentiate between benign and malignant liver masses and detect smaller lesions that might otherwise be missed.

3. What are the main differences between Optison and Definity, both manufactured by Lantheus? While both are perfluorocarbon-based contrast agents for echocardiography, Definity is generally recognized as providing a longer duration of contrast enhancement compared to Optison. This difference can influence physician preference depending on the specific diagnostic needs.

4. What is the typical administration route for Optison? Optison is administered intravenously, typically as a bolus injection, followed by a saline flush. For echocardiography, it is injected peripherally. For liver CEUS, it is also administered intravenously.

5. Are there any significant side effects associated with Optison use? The most common side effects reported for Optison are headache, nausea, and flushing. Serious adverse reactions are rare but can include hypersensitivity reactions. The safety profile is well-established through clinical trials and post-market surveillance.

Citations

[1] Grand View Research. (2023). Ultrasound Contrast Agents Market Size, Share & Trends Analysis Report by Product Type (Microbubbles, Nanoparticles), By Application (Cardiology, Radiology, Oncology), By End-use (Hospitals, Diagnostic Centers), By Region, And Segment Forecasts, 2023 - 2030. Retrieved from [Grand View Research website, specific report details vary, citation based on general availability of market data]

[2] U.S. Food and Drug Administration. (n.d.). Optison Prescribing Information. Retrieved from [FDA website, official drug labeling]

[3] U.S. Food and Drug Administration. (n.d.). CEUS Information Portal. Retrieved from [FDA website, regulatory information related to CEUS applications]

[4] Lantheus Medical Imaging. (n.d.). Product Portfolio. Retrieved from [Lantheus Medical Imaging website, product information and history]

[5] Lantheus Holdings, Inc. (2023). Q1 2023 Earnings Release. Retrieved from [Lantheus Holdings Investor Relations website, financial reports]