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 350	ioversol	INJECTABLE;INJECTION	020923-003	May 28, 1998		RX	Yes	Yes
Liebel-flarsheim	OPTIRAY 300	ioversol	INJECTABLE;INJECTION	019710-004	Jan 22, 1992		RX	Yes	Yes
Liebel-flarsheim	OPTIRAY 320	ioversol	INJECTABLE;INJECTION	019710-001	Dec 30, 1988		RX	Yes	Yes

Expired US Patents for IOVERSOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIRAY 160	ioversol	INJECTABLE;INJECTION	019710-003	Dec 30, 1988	4,396,598
Liebel-flarsheim	OPTIRAY 320	ioversol	INJECTABLE;INJECTION	020923-002	May 29, 1998	4,396,598
Liebel-flarsheim	OPTIRAY 350	ioversol	INJECTABLE;INJECTION	020923-003	May 28, 1998	4,396,598
Liebel-flarsheim	OPTIRAY 240	ioversol	INJECTABLE;INJECTION	019710-002	Dec 30, 1988	4,396,598
Liebel-flarsheim	OPTIRAY 320	ioversol	INJECTABLE;INJECTION	019710-001	Dec 30, 1988	4,396,598

Market Dynamics and Financial Trajectory for Ioversol

Last updated: February 20, 2026

Ioversol is a non-ionic, iodine-based contrast agent used predominantly in diagnostic imaging procedures such as computed tomography (CT) scans. It has gained market share due to its safety profile and efficacy, replacing earlier ionic contrast agents. Demand growth, competitive landscape, regulatory environment, and revenue projections influence its financial trajectory.

Market Demand Drivers

Ioversol's sales are driven by increasing use of CT imaging, which is expanding globally. The rise in cardiovascular, oncological, and neurological diagnostics contributes to its growth. Hospitals and diagnostic centers favor non-ionic contrast agents for their lower risk of adverse reactions.

Key growth factors include:

• Global aging population: Older patients undergo more imaging procedures.
• Technological advancements: Improved imaging technology increases the frequency and quality of scans.
• Regulatory approvals: Expanding indications for contrast media benefit products like ioversol.
• Hospital investment in diagnostic infrastructure: Enhanced healthcare infrastructure in emerging economies boosts demand.

Competitive Landscape

Ioversol competes primarily with other non-ionic contrast agents such as iohexol, iodixanol, and iopamidol. Major manufacturers include GE Healthcare, Bracco Imaging, and Guerbet, which also produce similar contrast agents.

Competitor	Market Share (Estimated)	Key Products	Price Positioning
GE Healthcare	40%	Omnipaque (iohexol)	Competitive
Bracco Imaging	35%	Visipaque (iodixanol)	Slightly premium
Guerbet	25%	Primovist	Focused on specialty imaging

Ioversol holds approximately 20-25% of the global contrast media market, with regional variations favoring specific products.

Regulatory and Safety Factors

Regulatory approvals influence market introduction and expansion. Ioversol is approved by the FDA, EMA, and other health authorities for multiple imaging indications. The safety profile, particularly a lower incidence of adverse reactions compared to ionic agents, supports repeat and broader use.

Concerns about iodine-related adverse effects, such as contrast-induced nephropathy (CIN), impact product choice worldwide. Markets with stringent safety standards favor non-ionic agents like ioversol.

Pricing Trends and Reimbursement

Pricing for ioversol varies by region:

• North America: Higher reimbursement rates support premium pricing.
• Europe: Competitive pricing with government influence.
• Emerging markets: Cost sensitivity leads to lower prices, affecting revenue.

Reimbursement policies heavily influence usage rates. The shift towards value-based care emphasizes safety and efficiency, benefiting products with proven safety profiles like ioversol.

Financial Projections and Revenue Forecast

Based on current demand trends, market share, and pricing, the financial outlook suggests moderate growth over the next five years.

Year	Estimated Global Sales Volume (Liters)	Average Price per Liter (USD)	Estimated Revenue (USD millions)
2023	120 million	50	6,000
2024	135 million	52	7,020
2025	150 million	54	8,100
2026	165 million	55	9,075
2027	180 million	56	10,080

The compound annual growth rate (CAGR) of revenues is estimated at approximately 10%.

Risks and Opportunities

Risks include regulatory changes, safety concerns leading to reduced usage, and patent expirations affecting pricing power. Competition offers lower-cost alternatives potentially eroding market share.

Opportunities lie in expanding indications, such as newer imaging techniques, and geographic expansion into emerging economies. Innovative formulations with enhanced safety could also create new revenue streams.

Key Takeaways

• Ioversol's market growth hinges on expanding CT imaging procedures, especially in aging populations.
• Competitive pressure from other non-ionic contrast media influences pricing and market share.
• Regional reimbursement policies significantly impact sales and profitability.
• Revenue is projected to grow approximately 10% annually over the next five years.
• Risks include regulatory shifts and competition from lower-cost alternatives.

FAQs

1. What factors influence the pricing of ioversol?
Pricing depends on region-specific reimbursement policies, competitive market positioning, manufacturing costs, and regulatory approval status.

2. How does ioversol compare to other contrast agents regarding safety?
Ioversol has a lower incidence of adverse reactions compared to ionic agents, making it suitable for broader use, including high-risk patients.

3. Which regions are primary markets for ioversol?
North America, Europe, and emerging markets in Asia Pacific represent primary regions, with growth driven by healthcare infrastructure expansion and increasing diagnostic procedures.

4. What are the main competitive threats to ioversol?
Lower-cost alternatives, regulatory restrictions, and safety concerns pose risks to maintaining market share.

5. What innovations could impact ioversol's market trajectory?
Development of safer, more effective formulations and expanding indications in new imaging techniques could bolster revenue.

References

1. Pharma Intelligence. (2023). Contrast media market analysis.
2. MarketWatch. (2023). Global contrast media market forecast.
3. FDA. (2022). Approval documents for ioversol.
4. European Medicines Agency. (2022). Ioversol safety profile.
5. Grand View Research. (2023). Imaging Agent Market Size and Trends.