Iopromide - Generic Drug Details

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

Iopromide is the generic ingredient in six branded drugs marketed by Bayer Hlthcare 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 iopromide. One supplier is listed for this compound.

Summary for iopromide

US Patents:	0
Tradenames:	6
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	13
What excipients (inactive ingredients) are in iopromide?	iopromide excipients list
DailyMed Link:	iopromide at DailyMed

Recent Clinical Trials for iopromide

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

Sponsor	Phase
University of Sao Paulo General Hospital	PHASE4
Bayer	Phase 4
Guerbet/Liebel-Flarsheim	Phase 4

See all iopromide clinical trials

Pharmacology for iopromide

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

Anatomical Therapeutic Chemical (ATC) Classes for iopromide

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 iopromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	ULTRAVIST 370	iopromide	INJECTABLE;INJECTION	020220-001	May 10, 1995		RX	Yes	Yes
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-003	Mar 12, 2004		DISCN	Yes	No
Bayer Hlthcare	ULTRAVIST 150	iopromide	INJECTABLE;INJECTION	020220-004	May 10, 1995		DISCN	Yes	No
Bayer Hlthcare	ULTRAVIST 300	iopromide	INJECTABLE;INJECTION	020220-002	May 10, 1995		RX	Yes	Yes
Bayer Hlthcare	ULTRAVIST 240	iopromide	INJECTABLE;INJECTION	020220-003	May 10, 1995		DISCN	Yes	No
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-001	Sep 20, 2002		RX	Yes	Yes
Bayer Hlthcare	ULTRAVIST 300 IN PLASTIC CONTAINER	iopromide	INJECTABLE;INJECTION	020220-005	Nov 18, 2008		DISCN	Yes	No

Expired US Patents for iopromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-003	Mar 12, 2004	4,364,921
Bayer Hlthcare	ULTRAVIST 300	iopromide	INJECTABLE;INJECTION	020220-002	May 10, 1995	4,364,921
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-001	Sep 20, 2002	4,364,921
Bayer Hlthcare	ULTRAVIST 240	iopromide	INJECTABLE;INJECTION	020220-003	May 10, 1995	4,364,921
Bayer Hlthcare	ULTRAVIST 150	iopromide	INJECTABLE;INJECTION	020220-004	May 10, 1995	4,364,921
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-002	Sep 20, 2002	4,364,921
Bayer Hlthcare	ULTRAVIST 370	iopromide	INJECTABLE;INJECTION	020220-001	May 10, 1995	4,364,921

Market Dynamics and Financial Trajectory for Iopromide

Last updated: February 13, 2026

Overview

Iopromide is a non-ionic, iodinated contrast agent primarily used in X-ray and computed tomography (CT) imaging procedures. Developed by Bracco Imaging, it has maintained a significant position within the contrast media sector. Its safety profile, high image quality, and broad applicability sustain consistent demand, especially in hematology and cardiology diagnostics.

Market Size and Growth Factors

The global contrast media market was valued at approximately $4.5 billion in 2022, with an expected compound annual growth rate (CAGR) of 4.5% through 2030. Iopromide, as a leading agent, contributes a substantial share, estimated at 15-20% of market revenue, translating to roughly $675 million to $900 million annually (based on 2022 data).

Growth factors include:

• Increasing global adoption of diagnostic imaging.
• Rising prevalence of diseases requiring CT scans, such as cardiovascular, neurological, and oncological conditions.
• Advancements in imaging technology enhancing demand for high-quality contrast agents.
• Expanding healthcare infrastructure in emerging markets.

Market Dynamics

1. Competitive Landscape

   Iopromide's primary competitors include iohexol (GE Healthcare), ioversol (Hengrui), and iodixanol (GE Healthcare). Bracco maintains a competitive edge through its established reputation, consistent supply, and innovation pipeline.

2. Regulatory Environment

   Regulatory approvals in diverse markets influence sales. The U.S. Food and Drug Administration (FDA) has classified Iopromide as “generally recognized as safe” (GRAS) for diagnostic use. Variations in approval processes can delay market expansion.

3. Pricing and Reimbursement

   Pricing strategies are driven by healthcare reimbursement policies, which vary globally. In the U.S., contrast agents are reimbursed through Medicare and private insurers, influencing revenue streams. Price pressure from biosimilar and generic entrants mitigates margins.

4. Supply Chain and Manufacturing

   High-quality manufacturing and reliable supply chains are critical. Bracco’s investment in GMP-compliant facilities and raw material sourcing underpins its market position. Disruptions due to regulatory changes or COVID-19 affected global supply chains but have largely normalized.

5. Patent and Patent Expiry

   Iopromide’s primary patents expired around 2018. Although no direct biosimilar competition exists due to the nature of contrast agents, generic competition exerts downward pressure on prices.

Financial Trajectory

• Revenue Trends

  Bracco’s contrast media segment generated approximately €1.4 billion (~$1.55 billion) in 2022, with Iopromide representing a significant component. Post-patent expiry, revenues are anticipated to decline gradually unless offset by increased market penetration or expanded indications.

• Profit Margins

  Due to competition and price erosion, profit margins for contrast agents have decreased. Gross margins hover around 60-65%, with net margins estimated at 15-20%. Cost management in manufacturing and supply chain efficiency are key to maintaining profitability.

• Future Revenue Potential

  Revenue decline may stabilize with new indications, such as use in molecular imaging, and expansion into emerging markets. An estimated CAGR of 2-3% for Iopromide’s market share post-patent expiry reflects mature market conditions.

Emerging Trends and Opportunities

• Development of next-generation contrast agents with reduced side effects (e.g., lower risk of nephrotoxicity).
• Integration with artificial intelligence to optimize imaging protocols.
• Increased use in minimally invasive diagnostics.

Risks

• Market entry of biosimilars or generics with comparable efficacy.
• Regulatory restrictions related to adverse effects.
• Reimbursement cuts due to healthcare budget pressures.
• Supply chain disruptions impacting manufacturing costs and availability.

Summary

Iopromide remains a key contrast agent with steady demand driven by diagnostic imaging needs. Its market share faces moderate pressures from generic competition, while opportunities exist in emerging applications and markets. Financially, revenues are expected to decline gradually due to patent expiration, but strategic innovations and geographic expansion may offset some of this decline.

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Key Takeaways

• Iopromide constitutes about 15-20% of the contrast media market, valued at approximately $675 million to $900 million annually.
• Market growth is primarily driven by increasing imaging procedures, especially in emerging markets.
• Patent expiry has introduced competitive pressures, leading to margin compression.
• Revenue is projected to decline gradually, with potential for stabilization through innovation and market expansion.
• Supply chain and regulatory considerations influence supply stability and market access.

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FAQs

1. What are the main drivers behind the demand for Iopromide?
   The increase in diagnostic imaging procedures globally and technological advancements in CT imaging drive demand.

2. How does patent expiry affect Iopromide’s market position?
   The expiry enables generic manufacturers to produce comparable competitors, exerting downward pricing pressure and reducing Bracco’s exclusive revenue potential.

3. What regulatory factors influence Iopromide’s sales?
   Approvals from agencies like the FDA and EMA are necessary for market entry; restrictions related to safety and side effects also impact sales.

4. Are there opportunities for growth despite patent expiry?
   Yes, through new indications, improved formulations, and expansion into emerging markets with less competition.

5. What risks could impact Iopromide’s future revenue?
   Competitive biosimilar entries, price pressures, regulatory restrictions, and supply chain disruptions pose significant risks.

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Citations

[1] MarketsandMarkets, "Contrast Media Market," 2023
[2] Bracco Imaging Financial Reports, 2022
[3] FDA, "Contrast Agents Overview," 2022
[4] GlobalData, "Contrast Media Market Analysis," 2023