ISOVUE-M 300 Drug Patent Profile

When do Isovue-m 300 patents expire, and when can generic versions of Isovue-m 300 launch?

Isovue-m 300 is a drug marketed by Bracco and is included in one NDA.

The generic ingredient in ISOVUE-M 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-m 300

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

Summary for ISOVUE-M 300

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	20
Patent Applications:	4,257
DailyMed Link:	ISOVUE-M 300 at DailyMed

Recent Clinical Trials for ISOVUE-M 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-M 300 clinical trials

Pharmacology for ISOVUE-M 300

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

US Patents and Regulatory Information for ISOVUE-M 300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	ISOVUE-M 300	iopamidol	INJECTABLE;INJECTION	018735-004	Dec 31, 1985	AP	RX	Yes	Yes

Expired US Patents for ISOVUE-M 300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	ISOVUE-M 300	iopamidol	INJECTABLE;INJECTION	018735-004	Dec 31, 1985

International Patents for ISOVUE-M 300

See the table below for patents covering ISOVUE-M 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

ISOVUE-M 300 Market Analysis and Financial Projection

Last updated: February 12, 2026

What Is ISOVUE-M 300 and Its Market Position?

ISOVUE-M 300 is the trade name for iodinated contrast agent containing 300 mg/mL iodine. It is used in diagnostic imaging procedures like computed tomography (CT) scans to enhance contrast. Manufactured by Bayer, it primarily targets hospitals, imaging centers, and diagnostic labs.

How Has the Market for Contrast Agents Evolved?

The global contrast media market reached approximately $4.3 billion in 2022. Compound annual growth rate (CAGR) projections estimate a rise of 4-6% annually through 2028. Key drivers include increasing prevalence of cardiovascular and oncological diseases requiring detailed imaging, greater adoption of minimally invasive procedures, and expanding healthcare infrastructure in emerging markets.

What Is the Competitive Landscape for ISOVUE-M 300?

It competes with other contrast agents such as

• Iohexol (Omnipaque)
• Iodixanol (Visipaque)
• Iopamidol (Isovue)

All have similar iodine concentrations and are used in similar diagnostic procedures. Bayer maintains a strong position through established hospital relationships; however, generic competition and alternative imaging modalities like MRI and ultrasound reduce its market share.

What Are the Pricing and Revenue Trends?

Pricing varies by region and insurance coverage. Average per-unit prices range from $20 to $50. Analyst estimates indicate Bayer's contrast media segment generated approximately $800 million in revenue in 2022, with ISOVUE-M 300 representing a substantial portion. Market share for ISOVUE-M 300 is estimated at 20-25% of the iodinated contrast media segment.

What Are Regulatory and Approval Trends?

ISOVUE-M 300 holds regulatory approvals across major markets including the FDA (U.S.), EMA (Europe), and PMDA (Japan). Recent updates include compliance with new cardiovascular safety guidelines and labeling revisions for pediatric use. Patent protections on the iodine compound expired in 2018, increasing generic competition.

What Are the Financial Projections and Risks?

Projected revenues for Bayer’s contrast media division are expected to grow in line with industry trends, reaching around $900 million by 2025, driven by increased imaging procedures and geographic expansion. Risks include:

• Regulatory hurdles
• Patent expirations
• Pricing pressures
• Competitive innovations

The rise of MRI as a non-invasive alternative reduces demand for iodinated contrast agents in some applications.

How Do Patent Expirations Affect Market Dynamics?

Patent expiry in 2018 opened the market to generics, reducing pricing and market share for branded ISOVUE-M 300. Generics account for roughly 70% of the contrast media market segments, exerting downward pressure on prices.

What Is the Impact of Technological Advancements?

Emerging techniques such as dual-energy CT and reduced contrast doses improve safety and could limit growth. The shift toward non-iodinated contrast agents in certain indications presents a long-term challenge for the segment.

Key Takeaways

• ISOVUE-M 300 operates in a competitive, mature market with steady growth.
• Patent expirations and generics have lowered pricing and margins.
• Regulatory compliance and safety enhancements remain essential for market access.
• The rise of alternative imaging techniques and contrast-free diagnostics present future challenges.
• Bayer’s ongoing innovation and market expansion could support margin stability.

FAQs

1. Will the demand for ISOVUE-M 300 increase in the next five years?
Demand will likely grow modestly as imaging procedures increase, especially in emerging markets; however, competition and technological shifts constrain rapid growth.

2. How are patents affecting ISOVUE-M 300?
Patent expirations in 2018 introduced generics, reducing Bayer’s market share and pricing power.

3. What role do regulatory changes play?
Regulatory updates focusing on safety, pediatric use, and labeling influence market access and can either restrict or expand usage.

4. Are alternative imaging modalities threatening iodinated contrast agents?
Yes; MRI and ultrasound reduce reliance on iodinated contrast, especially for non-urgent or specialized procedures.

5. What growth opportunities exist for Bayer’s contrast media segment?
Expansion into emerging markets and developing enhanced formulations for safety could provide future growth avenues.

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Citations
[1] MarketsandMarkets, "Contrast Media Market," 2022.
[2] Bayer Annual Report, 2022.
[3] Statista, "Global Contrast Media Market," 2022.