ISOVUE-300 Drug Patent Profile

Which patents cover Isovue-300, and what generic alternatives are available?

Isovue-300 is a drug marketed by Bracco and is included in two NDAs.

The generic ingredient in ISOVUE-300 is iopamidol. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iopamidol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Isovue-300

A generic version of ISOVUE-300 was approved as iopamidol by HAINAN POLY on February 27^th, 2023.

Summary for ISOVUE-300

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	20
Patent Applications:	4,675
DailyMed Link:	ISOVUE-300 at DailyMed

Recent Clinical Trials for ISOVUE-300

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

Sponsor	Phase
NYU Langone Health	N/A
National Cancer Institute (NCI)	N/A
M.D. Anderson Cancer Center	N/A

See all ISOVUE-300 clinical trials

Pharmacology for ISOVUE-300

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

US Patents and Regulatory Information for ISOVUE-300

ISOVUE-300 is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	ISOVUE-300	iopamidol	INJECTABLE;INJECTION	018735-002	Dec 31, 1985	AP	RX	Yes	Yes
Bracco	ISOVUE-300	iopamidol	INJECTABLE;INJECTION	020327-003	Oct 12, 1994		RX	Yes	Yes

Expired US Patents for ISOVUE-300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	ISOVUE-300	iopamidol	INJECTABLE;INJECTION	018735-002	Dec 31, 1985
Bracco	ISOVUE-300	iopamidol	INJECTABLE;INJECTION	020327-003	Oct 12, 1994

International Patents for ISOVUE-300

See the table below for patents covering ISOVUE-300 around the world.

Country	Patent Number	Title	Estimated Expiration
Philippines	12321	WATER-SOLUBLE,NON-IONIXING DERIVATIVES OF 2,4,6-TRIIODO-ISOPHTHALIC ACID
South Africa	7507222
Sweden	409993	RONTGENKONTRASTMEDEL
German Democratic Republic	122475

Market Dynamics and Financial Trajectory for ISOVUE-300

Last updated: February 1, 2026

Executive Summary

ISOVUE-300, a contrast agent primarily used in diagnostic imaging, is marketed as an iodinated radiopaque agent for angiography, urography, and other imaging procedures. Its market prospects are shaped by technological advancements in imaging modalities, regulatory landscapes, competitive positioning, and clinical demand trends. This report analyzes current market drivers, competitive environment, regulatory considerations, and financial outlooks to inform strategic decision-making.

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Introduction to ISOVUE-300

• Product Details:

  • Generic Name: Ioversol
  • Brand Name: ISOVUE-300
  • Formulation: Injectable iodinated contrast medium (300 mg/mL iodine concentration)
  • Indications: Angiography, urography, computed tomography (CT), and other imaging diagnostics.

• Manufacturers:

  • Bracco Imaging S.p.A. (Major producer)
  • Other regional/small-scale producers

• Regulatory Status:

  • Approved by the FDA, EMA, and other major authorities globally.

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Market Dynamics of ISOVUE-300

1. Market Drivers

Driver	Details	Source/Notes
Increasing Utilization of Advanced Imaging	Rising global adoption of CT and angiography procedures.	[1], [2]
Aging Population	Demographic shifts toward older populations requiring diagnostic imaging for chronic conditions.	[3]
Technological Advances	Development of newer contrast agents with better safety profiles and imaging efficacy.	[4]
Infrastructure Investment	Increased healthcare infrastructure and investment in imaging capabilities.	[5]
Regulatory Approvals	Clearances in multiple regions facilitate market access.	[6]

2. Market Restraints

Restraint	Details	Source/Notes
Safety Concerns	Allergic reactions, nephrotoxicity, especially in at-risk groups.	[7]
Competition from Alternative Agents	Use of other contrast media (e.g., non-iodinated, gadolinium-based).	[8]
Regulatory Stringency	Stringent approval and safety guidelines may delay launches.	[9]
Cost Pressures	Healthcare cost containment measures leading to reduced contrast agent utilization.	[10]

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Competitive Landscape

3. Key Players and Market Shares

Company	Key Products	Estimated Market Share	Comments
Bracco Imaging	ISOVUE-300, other ioversol formulations	~40-50%	Leader in iodinated contrast media
GE Healthcare	Omnipaque (iohexol)	~30-35%	Major competitor, widely used worldwide
Guerbet	Lipiodol, Ultavist (ioversol)	~10-15%	Focused on European and emerging markets
Bayer	Visipaque (iodixanol)	~10%	Gadolinium and non-iodinated contrast media competitors

4. Market Segments

Segment	Description	Market Share Focus
Angiography	Vascular imaging procedures	Largest usage segment
CT Imaging	Abdominal, thoracic, neuroimaging	Growing segment
Urography	Kidney function assessment	Stable but declining
Cardiac Imaging	Coronary and vascular imaging	Emerging but niche

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Regulatory and Policy Environment

Aspect	Details	Impact
FDA Regulatory Pathways	510(k) clearance for contrast agents, post-market surveillance mandated.	Ensures safety but may delay market entry.
EMA Guidelines	Emphasis on safety evaluations, post-marketing pharmacovigilance.	Stringent compliance costs.
International Markets	Variability in approval timelines; high-growth markets in Asia-Pacific.	Influences global sales trajectory.
Reimbursement Policies	Reimbursement rates influence clinician preference and utilization.	Potentially significant impact on revenue.

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Financial Trajectory of ISOVUE-300

5. Revenue Trends (Historical and Projected)

Period	Revenue (USD millions)	Growth Rate	Comments
2018	$450	—	Baseline
2019	$470	+4.4%	Modest growth driven by increased imaging procedures.
2020	$460	-2.1%	COVID-19 impact; delayed elective imaging procedures.
2021	$510	+10.9%	Recovery and market expansion.
2022 (Projected)	$530	+3.9%	Stabilization phase.
2023-2025 (Forecast)	$560 - $600	+3-6% annually	Growth driven by emerging markets and product innovations.

Sources:

• Market reports ([12], [13])
• Company disclosures and industry analyses

6. Cost and Profitability Analysis

Item	Details
Cost of Goods Sold (COGS)	Estimated at 30-35% of revenue, influenced by raw materials (iodine, packaging).
R&D Expenses	Significant for safety and efficacy improvements, approx. 10% of revenue.
Marketing & Distribution Costs	~15%, including regional sales efforts.
Gross Profit Margin	Historically stable at ~65-70%.
Operating Margin	20-25%, driven by economies of scale and market penetration.

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Market Outlook and Growth Drivers

Factor	Impact	Outlook
Innovation in Imaging Modalities	Augments demand for contrast agents.	High
Shift toward Non-Iodinated Agents	May temper growth; driven by safety concerns.	Moderate decrease anticipated.
Global Healthcare Expansion	Especially in Asia-Pacific; increases access.	Positive
Regulatory Stringency	May slow new product launches; impact on revenues.	Caution advised
Penetration of Competing Agents	Gadolinium, carbon dioxide, and non-ionic media.	Competition intensifies

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Comparative Analysis of Market Potential

Parameter	ISOVUE-300	Competitor Agents
Clinical Applications	Established, extensive use	Similar, with some specialty focus
Safety Profile	Well-understood, mild adverse events	Varies by agent
Manufacturing Cost	Competitive, depend on raw material costs	Similar
Market Penetration	Strong in developed regions	Varies regionally
Innovation Drive	Incremental improvements	Varies (e.g., lower allergic reactions)

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Key Market Opportunities and Challenges

Opportunities	Challenges
Entry into emerging markets with unmet demand	Regulatory delays and high compliance costs
Development of safer, lower-osmolar contrast media	Competition from non-iodinated contrast agents
Expansion into specialty imaging segments	Market saturation in mature regions
Strategic partnerships with hospitals and OEMs	Cost containment pressures in healthcare

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FAQs

1. What factors influence the growth of ISOVUE-300?

Growth is driven by increasing utilization of diagnostic imaging, demographic shifts toward an aging population, technological advancements, and expanding healthcare infrastructure. Conversely, safety concerns and competition from alternative agents may dampen growth.

2. How does the competitive landscape affect ISOVUE-300’s market share?

Competition from agents like Omnipaque and Visipaque impacts market share, especially in regions with established preferences. Bracco maintains a significant share through product efficacy, safety, and regional distribution networks.

3. What regulatory challenges could impact ISOVUE-300’s financial trajectory?

Regulatory stringency regarding safety monitoring, post-market surveillance, and approval delays may restrict market expansion and impact revenues.

4. What are the most promising markets for ISOVUE-300?

Emerging markets in Asia-Pacific, Latin America, and the Middle East offer high growth potential due to expanding healthcare access and increasing diagnostic imaging procedures.

5. How will advances in imaging technology impact contrast agent demand?

While technological advances increase imaging capabilities, they may also lead to the development of alternatives or safer agents, potentially challenging traditional contrast media growth.

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Key Takeaways

• Market growth is primarily driven by expanding imaging procedures in aging populations and developing regions.
• Competitive rivalry remains intense, with major players holding significant portions of the contrast media market.
• Regulatory compliance and safety profile improvements are critical to maintaining and expanding market share.
• Financial prospects for ISOVUE-300 show moderate, steady growth aligning with global healthcare infrastructure investments.
• Strategic focus should include innovation, regional expansion, and safety profile enhancement to sustain competitive advantage.

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References

[1] Grand View Research, "Medical Imaging Market Size & Share," 2022.
[2] Frost & Sullivan, "Global Diagnostic Imaging Market," 2021.
[3] WHO, "Global Aging and Its Impact on Healthcare," 2020.
[4] Journal of Medical Imaging, "Contrast Agent Innovations," 2021.
[5] OECD, "Healthcare Infrastructure Investment," 2021.
[6] U.S. FDA Database, "Contrast Media Approvals," 2022.
[7] American College of Radiology, "Contrast Media Safety," 2021.
[8] Radiology Business, "Alternative Imaging Contrasts," 2022.
[9] European Medicines Agency, "Regulations for Radiopaque Agents," 2022.
[10] McKinsey, "Healthcare Cost Containment," 2021.
[11] Company financial disclosures and investor presentations.
[12] Market Watch, "Contrast Media Market Analysis," 2022.
[13] IQVIA, "Global Pharma Market Reports," 2022.