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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	20
Patent Applications:	2,822
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

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

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

International Patents for OPTISON

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

Country	Patent Number	Title	Estimated Expiration
Canada	2273140	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)
Germany	69117518
Japan	H06508108
Ireland	73259	Chemical compounds

Supplementary Protection Certificates for OPTISON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1853250	C300673	Netherlands		PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
1853250	122014000065	Germany		PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
1853250	300673	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

OPTISON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Optison: A Comprehensive Analysis

Introduction

Optison, an ultrasound contrast agent, has been a significant player in the diagnostic imaging market, particularly in cardiology applications. Here, we delve into the market dynamics and financial trajectory of Optison, highlighting its history, current market position, and future prospects.

History and Approval

Optison was originally approved by the U.S. Food and Drug Administration (FDA) in 1998 for use in patients with suboptimal echocardiograms to opacify the left ventricle and improve the delineation of the left ventricular endocardial borders[4].

Market Interruption and Relaunch

Despite its approval, Optison faced a significant interruption in its supply. GE Healthcare took Optison off the market in June 2009 due to manufacturing difficulties. However, after a thorough review and changes to the manufacturing process, GE Healthcare relaunched Optison in 2022, ensuring a more stable supply chain[4].

Market Position

Optison is one of only two ultrasound contrast agents for cardiology applications commercially available in the U.S., the other being Definity from Lantheus Medical Imaging. Both products have been required to carry black box warning labels since 2007 due to patient safety concerns[4].

Safety and Efficacy

Since its initial approval, more than 1 million doses of Optison have been administered, with only 16 serious adverse events reported. This safety profile, combined with its efficacy in improving echocardiogram quality, has maintained its relevance in the market[4].

Market Dynamics

Demand for Diagnostic Imaging

The demand for diagnostic imaging operations, including ultrasound contrast agents like Optison, has been driven by increased public awareness of the importance of early disease identification and preventative healthcare. Chronic conditions such as cardiovascular diseases, cancer, and neurological disorders require frequent medical imaging for diagnosis and monitoring, contributing to the growing demand for contrast media[1].

Competitive Landscape

The U.S. contrast media market is competitive, with key players adopting strategies such as mergers and acquisitions, and indication extension to enhance their market position. For instance, GE Healthcare's relaunch of Optison and its plans to expand its use globally are part of this competitive strategy[1][2].

Financial Trajectory

Revenue and Growth

The U.S. contrast media market, which includes Optison, was valued at USD 2.43 billion in 2022 and is expected to grow at a CAGR of 4.1% from 2023 to 2030. The cardiovascular disorder segment, where Optison is primarily used, is expected to grow at the fastest CAGR of 5.4% during this period[1].

Financial Performance of GE Healthcare

GE Healthcare, the manufacturer of Optison, has reported significant revenues from its Pharmaceutical Diagnostics segment. For example, the segment generated $2.0 billion in revenue, highlighting the financial viability of contrast agents like Optison within the broader diagnostic imaging market[2].

Strategic Initiatives

Expansion and Distribution

GE Healthcare has plans to expand Optison in the U.S. and Sonazoid globally, indicating a strategic push to increase market share and revenue. This expansion is supported by distribution deals and other strategic partnerships[2][4].

Manufacturing Improvements

The relaunch of Optison following manufacturing process improvements is a critical strategic initiative. This ensures a stable supply chain, reducing the risk of future interruptions and enhancing customer confidence in the product[4].

Regulatory Environment

FDA Approvals and Guidelines

The FDA has played a crucial role in the market dynamics of Optison. The removal of contraindications for ultrasound contrast agents and the approval of new configurations, such as the 20-vial pack configuration of Lumason, have positively impacted the market for ultrasound contrast agents[1].

Safety Regulations

Despite the black box warning labels, the safety profile of Optison has been managed effectively. The FDA's oversight ensures that the product meets stringent safety standards, which is essential for maintaining market trust[4].

Future Prospects

Technological Advancements

The development of new technologies, such as nanoparticulate systems for contrast agents, is expected to improve the biocompatibility, stability, and safety profile of products like Optison. These advancements could further drive market growth[1].

Market Growth Drivers

The growing incidence of chronic diseases and the increasing demand for early disease detection are key drivers for the contrast media market. As healthcare systems emphasize preventative care, the demand for diagnostic imaging tools, including Optison, is likely to increase[1].

Key Takeaways

• Market Growth: The U.S. contrast media market, including Optison, is expected to grow at a CAGR of 4.1% from 2023 to 2030.
• Safety and Efficacy: Optison has a strong safety profile with over 1 million doses administered and only 16 serious adverse events reported.
• Strategic Initiatives: GE Healthcare's plans to expand Optison and improve manufacturing processes are key to its market success.
• Regulatory Environment: FDA approvals and guidelines play a crucial role in the market dynamics of Optison.
• Future Prospects: Technological advancements and growing demand for diagnostic imaging are expected to drive the market forward.

FAQs

What is Optison used for?

Optison is used in patients with suboptimal echocardiograms to opacify the left ventricle and improve the delineation of the left ventricular endocardial borders.

Why was Optison taken off the market in 2009?

Optison was taken off the market in 2009 due to manufacturing difficulties.

What are the safety concerns associated with Optison?

Optison and Definity, another ultrasound contrast agent, carry black box warning labels due to patient safety concerns, although Optison has a strong safety profile with only 16 serious adverse events reported since its approval.

How does the FDA impact the market for Optison?

The FDA's approvals and guidelines, including the removal of contraindications for ultrasound contrast agents, significantly influence the market dynamics of Optison.

What are the future prospects for Optison in the diagnostic imaging market?

The future prospects for Optison are positive, driven by technological advancements, growing demand for diagnostic imaging, and strategic initiatives by GE Healthcare to expand its use.

Sources

1. Grand View Research: U.S. Contrast Media Market Size, Share, Trends Report 2030.
2. GE HealthCare: Investor Day Presentation.
3. Brookings: Addressing the Trade-Off Between Lower Drug Prices and Incentives for Pharmaceutical Innovation.
4. AuntMinnie: GE relaunches Optison ultrasound contrast.