Ioversol - Generic Drug Details

What are the generic sources for ioversol and what is the scope of patent protection?

Ioversol is the generic ingredient in five branded drugs marketed by Liebel-flarsheim and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for ioversol. One supplier is listed for this compound.

Summary for ioversol

US Patents:	0
Tradenames:	5
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	6
What excipients (inactive ingredients) are in ioversol?	ioversol excipients list
DailyMed Link:	ioversol at DailyMed

Recent Clinical Trials for ioversol

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

Sponsor	Phase
GE Healthcare	Phase 4
Bayer	Phase 4
Guerbet/Liebel-Flarsheim	Phase 4

See all ioversol clinical trials

Pharmacology for ioversol

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

Anatomical Therapeutic Chemical (ATC) Classes for ioversol

V08AB	Watersoluble, nephrotropic, low osmolar X-ray contrast media
V08A	X-RAY CONTRAST MEDIA, IODINATED
V08	CONTRAST MEDIA
V	Various

US Patents and Regulatory Information for ioversol

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 350	ioversol	INJECTABLE;INJECTION	019710-005	Jan 22, 1992		RX	Yes	Yes
Liebel-flarsheim	OPTIRAY 160	ioversol	INJECTABLE;INJECTION	019710-003	Dec 30, 1988		DISCN	No	No
Liebel-flarsheim	OPTIRAY 320	ioversol	INJECTABLE;INJECTION	020923-002	May 29, 1998		RX	Yes	Yes
Liebel-flarsheim	OPTIRAY 240	ioversol	INJECTABLE;INJECTION	020923-001	May 28, 1998		DISCN	No	No
Liebel-flarsheim	OPTIRAY 300	ioversol	INJECTABLE;INJECTION	020923-004	May 13, 1999		DISCN	Yes	No

Expired US Patents for ioversol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIRAY 320	ioversol	INJECTABLE;INJECTION	019710-001	Dec 30, 1988
Liebel-flarsheim	OPTIRAY 160	ioversol	INJECTABLE;INJECTION	019710-003	Dec 30, 1988
Liebel-flarsheim	OPTIRAY 350	ioversol	INJECTABLE;INJECTION	019710-005	Jan 22, 1992
Liebel-flarsheim	OPTIRAY 320	ioversol	INJECTABLE;INJECTION	020923-002	May 29, 1998
Liebel-flarsheim	OPTIRAY 300	ioversol	INJECTABLE;INJECTION	019710-004	Jan 22, 1992

Market Dynamics and Financial Trajectory for Ioversol: A Strategic Outlook

Last updated: August 1, 2025

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Introduction

Ioversol, a non-ionic, water-soluble contrast agent primarily employed in radiographic imaging such as computed tomography (CT) scans, has gained notable prominence within the diagnostic imaging sector. Its unique molecular properties, including low osmolality and improved patient safety profiles over older contrast agents, underpin its widespread adoption. Given the evolving landscape of imaging diagnostics, technological innovation, regulatory standards, and regional market dynamics, understanding the current market trajectory and future financial prospects for Ioversol is vital for pharmaceutical manufacturers, investors, and healthcare stakeholders.

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Market Overview

The global contrast agent market, valued at approximately USD 4.5 billion in 2022, encompasses a range of iodinated agents, including Ioversol, amid other modalities such as MRI and ultrasound. The pivot toward precision diagnostics, increasing prevalence of chronic diseases like cancer, cardiovascular, and neurological conditions, and expanding access to advanced imaging facilities collectively bolster demand for iodinated contrast media (ICMs).

Ioversol, marketed under brands such as Optiray by GE Healthcare, benefits from its high image quality, reduced adverse reactions, and compatibility with a broad spectrum of imaging protocols. Its adoption spans diagnostic radiology centers, hospitals, and outpatient clinics across North America, Europe, Asia-Pacific, and emerging markets.

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Market Dynamics Influencing Ioversol

Technological Innovation and Diagnostic Imaging Advancements

Advancements in imaging modalities, including low-dose CT protocols and hybrid imaging techniques (e.g., PET/CT), influence contrast agent selection. The preference for high-quality, patient-safe contrast media favors Ioversol’s low osmolality and enhanced tolerability profile.

Emerging developments, such as digital adaptive imaging and AI-enhanced diagnostics, may redefine contrast media requirements. However, Ioversol’s established efficacy positions it favorably amidst these technological shifts.

Regulatory Environment and Safety Standards

Regulatory agencies like the FDA and EMA impose stringent safety, efficacy, and manufacturing quality standards. Ioversol’s clinical safety record—namely, its reduced risk of adverse reactions compared to high-osmolar contrast agents—facilitates favorable regulatory assessments and market access.

Ongoing evaluations for additional indications or formulations could impact its market presence. Additionally, emerging concerns over gadolinium-based agents’ long-term safety reinforce the importance of iodinated contrast media, bolstering Ioversol’s role.

Prevalence of Target Diseases and Demographics

The rising incidence of cardiovascular diseases, cancer, and infectious diseases requiring detailed imaging directly influences Ioversol demand. Population aging, particularly in developed markets, amplifies the need for advanced diagnostic tools.

In regions like Asia-Pacific and Latin America, improving healthcare infrastructure and rising healthcare expenditure open expansive growth avenues for Ioversol.

Competitive Landscape

Ioversol faces competition from other iodinated contrast agents such as Iohexol, Iodixanol, and Visipaque, each with distinct safety and efficacy profiles. Yet, Ioversol’s balance of image quality and safety continues to sustain its competitive edge.

Brand loyalty, pricing strategies, and patent statuses significantly influence market share dynamics. Patent expirations, such as for specific formulations, could lead to generic competition, impacting pricing and profitability.

Market Penetration and Distribution

Strong relationships with healthcare providers, adoption by radiology centers, and inclusion in clinical guidelines enhance Ioversol’s market penetration. Distribution logistics, local regulatory approvals, and reimbursement policies further shape supply chains and sales performance.

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Financial Trajectory and Revenue Outlook

Current Revenue Performance

Leading manufacturers like GE Healthcare and Bracco Imaging report global revenues in the hundreds of millions USD range for their contrast agent portfolios, with Ioversol constituting a significant segment. The consistent upward trajectory aligns with increased imaging procedures, projected at a CAGR of approximately 4.2% over the next five years (2022-2027).

Growth Drivers

• Expanding Markets in Asia-Pacific and Latin America: Rapid economic growth and healthcare infrastructure development fuel demand.
• Innovation in Formulations: Developments such as low-osmolar formulations or improved stability contribute to portfolio diversification.
• Integration with Digital Imaging Technologies: Compatibility with advanced imaging enhances clinical utility and market appeal.

Challenges and Market Risks

• Pricing Pressures: Healthcare cost containment initiatives and reimbursement constraints may compress margins.
• Patent Expirations and Generic Competition: The emergence of generic formulations could significantly reduce unit prices.
• Regulatory Modifications: New safety requirements may impose additional compliances, increasing costs.

Projected Revenue Growth

Based on current market trends, the Ioversol segment is expected to sustain a compound annual growth rate (CAGR) of 3-5% over the next five years. Revenue streams will likely expand in emerging markets, supported by increasing diagnostic imaging volumes and healthcare investments.

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Strategic Considerations for Stakeholders

• Portfolio Diversification: Incorporating value-added formulations or complementary diagnostic agents to mitigate reliance solely on Ioversol.
• Investments in Regulatory and Clinical Development: Securing approvals for new formulations or indications can extend lifecycle and market share.
• Pricing and Contracting Strategies: Engaging with payers and healthcare institutions to optimize reimbursement and access, especially amid cost containment.

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Key Market Trends and Future Outlook

• The integration of AI-driven imaging analysis is expected to increase demand for high-quality contrast agents like Ioversol.
• Enhanced safety profiles and lower adverse event rates support continued clinical preference over older or alternative agents.
• Increasing regulatory focus on safety data transparency could influence formulation and marketing strategies.
• Market expansion hinges on successful navigation of patent landscapes and competition from generics.

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Conclusion

Ioversol stands as a cornerstone contrast agent within the iodinated contrast media market, bolstered by technological advances, demographic shifts, and regulatory endorsments favoring its safety profile. Its financial trajectory is robust, with steady growth anticipated amid expanding imaging needs. Stakeholders must leverage strategic positioning—through innovation, market expansion, and regulatory agility—to capitalize on upcoming opportunities and mitigate risks.

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Key Takeaways

• The global Ioversol market is poised for steady growth, driven by rising diagnostic imaging volumes, especially in emerging economies.
• Technological advances and safety profiles make Ioversol a preferred agent, though generic competition remains a significant threat.
• Regulatory standards and healthcare policy changes will influence pricing and market access dynamics.
• Strategic investments in formulation innovation and geographic expansion can enhance revenue streams.
• The increasing integration of AI and digital health solutions will shape future market demand for high-quality contrast agents like Ioversol.

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FAQs

Q1: How does Ioversol compare to other iodinated contrast agents regarding safety?

A1: Ioversol's low osmolality reduces the incidence of adverse reactions, making it safer than older high-osmolar agents. Clinical data confirm a favorable safety profile, especially in patients with compromised renal function.

Q2: What are the primary applications of Ioversol?

A2: Ioversol is predominantly used in computed tomography (CT) imaging to enhance visualization of vascular structures and organs. It also finds applications in angiography and other radiographic procedures requiring contrast enhancement.

Q3: How will patent expirations affect Ioversol's market presence?

A3: Patent expirations enable generic manufacturers to produce cost-effective alternatives, potentially reducing prices, market share, and profit margins for branded Ioversol formulations.

Q4: What regional markets offer the most growth opportunities for Ioversol?

A4: Asia-Pacific and Latin America are poised for significant growth due to expanding healthcare infrastructure, increasing diagnostic procedures, and rising healthcare spending.

Q5: How might technological innovations impact the demand for Ioversol in the future?

A5: Advances like AI-enhanced imaging protocols may increase demand for contrast agents that deliver superior image quality and safety, positioning Ioversol favorably as imaging technology evolves.

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References:

1. Market Research Future, "Contrast Media Market Analysis," 2022.
2. IMV Medical Information Division, "Contrast Media Market Data & Trends," 2022.
3. FDA and EMA safety and efficacy guidelines on iodinated contrast media, 2021.
4. GlobalData, "Healthcare Infrastructure & Imaging Market Outlook," 2023.