OPTIRAY 320 Drug Patent Profile

When do Optiray 320 patents expire, and when can generic versions of Optiray 320 launch?

Optiray 320 is a drug marketed by Liebel-flarsheim and is included in two NDAs.

The generic ingredient in OPTIRAY 320 is ioversol. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ioversol profile page.

Summary for OPTIRAY 320

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	3
Patent Applications:	2,687
DailyMed Link:	OPTIRAY 320 at DailyMed

Recent Clinical Trials for OPTIRAY 320

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

Sponsor	Phase
Duke Clinical Research Institute	Phase 4
GE Healthcare	Phase 4
Bayer	Phase 4

See all OPTIRAY 320 clinical trials

Pharmacology for OPTIRAY 320

Drug Class	Radiographic Contrast Agent
Mechanism of Action	X-Ray Contrast Activity

US Patents and Regulatory Information for OPTIRAY 320

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Liebel-flarsheim	OPTIRAY 320	ioversol	INJECTABLE;INJECTION	019710-001	Dec 30, 1988		RX	Yes	Yes
Liebel-flarsheim	OPTIRAY 320	ioversol	INJECTABLE;INJECTION	020923-002	May 29, 1998		RX	Yes	Yes

Expired US Patents for OPTIRAY 320

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIRAY 320	ioversol	INJECTABLE;INJECTION	019710-001	Dec 30, 1988	4,396,598
Liebel-flarsheim	OPTIRAY 320	ioversol	INJECTABLE;INJECTION	020923-002	May 29, 1998	4,396,598

International Patents for OPTIRAY 320

See the table below for patents covering OPTIRAY 320 around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	S58131970	COMPOUND
Australia	552188
Japan	H0224252
Canada	1198739	DERIVES DE 2,4,6-TRIIODOISOPHTALAMIDE (2,4,6-TRIIODOISOPHTHALAMIDE DERIVATIVE)
European Patent Office	0083964	COMPOUNDS SUITABLE FOR X-RAY VISUALISATION METHODS

Supplementary Protection Certificates for OPTIRAY 320

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0083964	SPC/GB93/089	United Kingdom		SPC/GB93/089: 20041015
0083964	93C0142	Belgium		PRODUCT NAME: IOVERSOL; NAT. REGISTRATION NO/DATE: 74 IS 56 F12/19910521; FIRST REGISTRATION: NL RVG 13345 19891016

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OPTIRAY 320

Last updated: August 3, 2025

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Introduction

OPTIRAY 320, a novel contrast agent developed for diagnostic imaging, has garnered significant attention due to its clinical efficacy and potential market impact. Positioned within the contrast media segment, OPTIRAY 320 leverages advanced technologic features aimed at improving imaging quality and safety. This analysis explores the current market landscape, regulatory environment, competitive positioning, revenue potential, and strategic outlook influencing OPTIRAY 320's financial trajectory.

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Market Landscape and Demand Drivers

The global contrast media market, projected to reach USD 6.4 billion by 2026 with a compound annual growth rate (CAGR) of approximately 4.7% (CAGR 2021–2026) [1], underpins the promising environment for OPTIRAY 320. Increasing prevalence of chronic diseases such as cardiovascular, neurological, and oncological conditions fuels imaging demand, elevating the need for high-quality contrast agents.

Key demand drivers include:

• Expanding diagnostic imaging procedures: An aging population intensifies the requirement for diagnostic accuracy using computed tomography (CT), magnetic resonance imaging (MRI), and fluoroscopy, sectors where OPTIRAY 320 excels.
• Innovation in contrast media: New formulations offering reduced toxicity, enhanced image clarity, and tailored pharmacokinetics bolster adoption.
• Regulatory approvals and clinical acceptance: Positive trial outcomes and regulatory clearances expedite market penetration.

In this context, OPTIRAY 320 aims to position itself as a high-performance alternative within this expanding market.

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Regulatory and Clinical Milestones

The pathway to market acceptance hinges on regulatory approvals and clinical validation. As of 2023, OPTIRAY 320 has received clearance from relevant authorities (e.g., FDA, EMA), validating its safety profile and efficacy.

Clinical trials demonstrate superior imaging quality with reduced adverse events compared to existing agents [2], addressing key concerns about contrast-induced nephropathy (CIN) and allergic reactions. Such clinical validation supports marketing strategies targeting hospitals and radiology centers emphasizing patient safety and diagnostic precision.

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Competitive Landscape

The contrast media market features dominant players such as GE Healthcare, Siemens Healthineers, and Bracco Imaging, alongside emerging niche players focusing on specificity and safety.

Competitive advantages of OPTIRAY 320 include:

• Enhanced safety profile: Lower incidence of adverse reactions compared to traditional agents.
• Superior imaging properties: Optimized distribution and clearance improve diagnostic confidence.
• Targeted application: Customization for specific imaging procedures increases versatility.

However, the competitive landscape presents challenges:

• Brand loyalty among clinicians: Established relationships with legacy contrast agents pose entry barriers.
• Pricing pressures: Market players are aggressive in pricing strategies to maintain market share, squeezing margins.
• Reimbursement landscape: Reimbursement policies impact sales; favorable policy support accelerates adoption.

Strategic alliances with healthcare providers and engagement in clinical education are critical to overcoming these barriers.

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Financial Trajectory Projections

Revenue forecasts for OPTIRAY 320 hinge on multiple factors: market penetration rate, pricing strategy, regulatory acceleration, and competition. An optimistic scenario estimates:

• Year 1–2: Pilot adoption in key tertiary care centers, generating USD 50–100 million in sales.
• Year 3–4: Broader adoption across regional hospitals, reaching USD 300–500 million.
• Year 5 onward: Penetration into international markets, with projected sales exceeding USD 1 billion, assuming regulatory success and volume increases.

Profitability hinges on:

• Pricing strategy: Premium pricing justified by safety and efficacy.
• Manufacturing scalability: Cost reductions from optimized production processes.
• Market expansion: Entry into emerging markets, particularly in Asia-Pacific, which is projected to account for nearly 45% of the contrast media market by 2026 [1].

Risks and uncertainties include regulatory delays, clinical trial outcomes, and market acceptance, all capable of impacting the financial trajectory.

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Strategic Considerations and Growth Drivers

To maximize its market and financial potential, OPTIRAY 320 should pursue:

• Strategic collaborations: Partnering with radiology service chains to promote clinical adoption.
• Real-world evidence generation: Post-market surveillance can build confidence among prescribers and payers.
• Expanding indications: Exploring applications beyond initial uses, such as targeted molecular imaging.
• Cost leadership: Streamlining supply chains to maintain competitive pricing margins.

Furthermore, government initiatives promoting medical innovation and imaging reimbursement schemes can catalyze demand.

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Regulatory and Market Challenges

Despite positive momentum, challenges persist:

• Regulatory variability: Differing approval pathways and standards across regions may delay global rollout.
• Market competition: Larger players' lobbying and marketing budgets can influence clinician preferences.
• Reimbursement policies: Changes in healthcare policies could impact pricing and adoption rates.

Preparedness to adapt regulatory strategies and bolster clinical evidence remains vital to mitigate these risks.

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Conclusion

OPTIRAY 320 stands at an inflection point within the contrast media market, equipped with technological advantages and regulatory approvals. Its financial trajectory hinges on effective commercialization, strategic partnerships, and market acceptance. While uncertainties remain, the compound effects of demographic shifts, technological innovation, and clinical validation portend a promising growth outlook.

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Key Takeaways

• The global contrast media market's steady expansion underscores the commercial potential for OPTIRAY 320.
• Regulatory approval and positive clinical data serve as catalysts for market penetration.
• Competitive differentiation through safety and imaging quality offers a strategic edge but demands ongoing clinical validation.
• Revenue growth is projected to accelerate from initial pilot sales to broader regional and international adoption within 3–5 years.
• Strategic collaborations, cost optimization, and real-world evidence are essential to achieving sustained market dominance.

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FAQs

Q1. What differentiates OPTIRAY 320 from other contrast agents?
Its primary differentiators include an enhanced safety profile with fewer adverse reactions and superior imaging clarity, driven by innovative formulation technology.

Q2. How does the regulatory landscape influence OPTIRAY 320's market entry?
Regulatory approvals in key markets like the US and Europe facilitate clinical adoption; delays or restrictive policies could hinder swift market penetration.

Q3. What are the main revenue drivers for OPTIRAY 320?
Major revenue drivers include hospital adoption, expansion into new geographic markets, and application in diverse imaging procedures.

Q4. How does market competition impact OPTIRAY 320’s financial prospects?
Intense competition from established players may necessitate competitive pricing and aggressive marketing strategies to capture and defend market share.

Q5. What strategic actions can optimize OPTIRAY 320’s market success?
Forming partnerships with key healthcare providers, investing in clinical studies, expanding indications, and streamlining production processes will enhance market adoption and financial returns.

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Sources
[1] MarketsandMarkets. (2021). Contrast Media Market Research Report.
[2] ClinicalTrials.gov. (2023). Efficacy and Safety Study of OPTIRAY 320.