RIMSO-50 Drug Patent Profile

Which patents cover Rimso-50, and what generic alternatives are available?

Rimso-50 is a drug marketed by Mylan Institutional and is included in one NDA.

The generic ingredient in RIMSO-50 is dimethyl sulfoxide. There are seventy-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dimethyl sulfoxide profile page.

Summary for RIMSO-50

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for RIMSO-50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Institutional	RIMSO-50	dimethyl sulfoxide	SOLUTION;INTRAVESICAL	017788-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

International Patents for RIMSO-50

See the table below for patents covering RIMSO-50 around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	6465158
Sweden	331768
Netherlands	149702
Denmark	123979
Netherlands	6414294

Supplementary Protection Certificates for RIMSO-50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1131065	92488	Luxembourg		PRODUCT NAME: DIMETHYL FUMARATE. FIRST REGISTRATION: 20140130
2137537	122014000069	Germany		PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2137537	300674	Netherlands		PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2137537	201440024	Slovenia		PRODUCT NAME: DIMETHYL FUMARATE; NATIONAL AUTHORISATION NUMBER: EU/1/13/837/001-002; DATE OF NATIONAL AUTHORISATION: 20140130; AUTHORITY FOR NATIONAL AUTHORISATION: EU
1131065	PA2014023	Lithuania		PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130

RIMSO-50 (Osmotic Diatrizoate Meglumine) Investment Scenario and Fundamentals Analysis

Last updated: February 6, 2026

Overview
RIMSO-50 is a brand of diatrizoate meglumine, an iodinated contrast agent primarily used in diagnostic imaging procedures such as computed tomography (CT) scans and angiography. It is marketed by Bracco Diagnostics, a division of Bracco Imaging. The product's investment potential depends on market size, competitive landscape, regulatory environment, and future growth drivers.

Market Size and Demand
Global demand for iodinated contrast media stood at approximately USD 2.5 billion in 2022, with a compound annual growth rate (CAGR) of about 4% projected through 2030. RIMSO-50 competes within a mature segment characterized by high annual R&D and manufacturing costs. Key regional markets include North America (45%), Europe (30%), and Asia-Pacific (15%). The remaining 10% is split between Latin America, Middle East, and Africa. North America remains the dominant revenue generator, driven by high procedure volumes and adoption of advanced imaging modalities.

Competitive Landscape
The contrast agent market features dominant players such as GE Healthcare, Bracco, Bayer, and Guerbet. Patents for older compounds like diatrizoate are largely expired or approaching expiration, leading to generic competition. Key competitors include:

• Bayer’s Xenetix (iopromide)
• GE’s Omnipaque (iohexol)
• Guerbet’s Ultravist (iopromide)

Despite competition, RIMSO-50 maintains a niche due to existing contracts, brand recognition, and distribution channels.

Regulatory Environment and Approvals
Regulatory approval is critical for long-term viability. RIMSO-50 carries FDA approval, with a standard 510(k) clearance for imaging contrast use. Regulatory complexities include:

• Strict safety profiling due to iodine content.
• Ongoing surveillance for adverse effects such as contrast-induced nephropathy and allergic reactions.
• Approval retention in key markets is contingent upon post-market surveillance compliance.

Patent protections no longer apply, elevating market entry risks for generics but also increasing market competition.

Growth Drivers and Risks
Drivers:

• Expansion of diagnostic imaging, especially in emerging markets.
• Increasing prevalence of chronic diseases requiring imaging diagnostics.
• Technological advancements that improve imaging quality and reduce contrast volume.

Risks:

• Competition from newer, lower-risk contrast agents such as gadolinium-based agents or CO2 contrast.
• Regulatory risks associated with safety concerns.
• Price erosion due to generic entries.
• Contractual dependencies on healthcare providers and distributors.

Financial Fundamentals
Specific financial data for RIMSO-50 is limited given its classification as a mature pharmaceutical product. However:

• Bracco’s contrast media division reported revenues exceeding EUR 1.7 billion in 2022, with a portion attributable to RIMSO-50.
• Gross margins for contrast agents typically range from 60% to 70%.
• The segment’s R&D expenses are primarily directed toward safety and compliance rather than new product development.

Investment Considerations
Given the mature market, RIMSO-50's revenue streams are stable but limited by patent expiration and aggressive generic competition. Future growth prospects hinge on expanding penetration into emerging markets and potential new indications or formulations. The company's ability to maintain profitability depends on managing manufacturing costs and contractual terms.

Valuation Metrics
Industry valuation multiples for diagnostic imaging products:

Metric	Range
Price/Earnings (P/E)	15x – 20x
Enterprise Value/EBITDA	10x – 14x
Revenue multiple	3x – 5x

RIMSO-50’s valuation is embedded within Bracco’s overall financial profile. The contribution from contrast media segment remains steady but faces pressure from generics and alternative imaging modalities.

Legal and Patent Outlook
The expiration of key patents in the late 2010s has opened space for generic competitors, reducing margins. However, exclusive supply agreements and existing customer relationships mitigate immediate risks. Patent expirations generally lead to volume shifts rather than drastic revenue declines if proper market share is maintained.

Concluding Remarks
RIMSO-50’s investment appeal stems from its established market position, steady revenue streams, and the growing demand for diagnostic imaging. Risks associated with generics, safety profiles, and technological competition must be managed. Currently, it is more suitable as a stable income component in diversified portfolios rather than a high-growth asset.

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Key Takeaways:

• RIMSO-50 is a mature contrast agent with steady revenues primarily from North America and Europe.
• Competitive pressures from generics erode margins but are offset by contractual and brand advantages.
• Growth depends on market expansion and regulatory navigation.
• Valuation multiples suggest limited upside but stable cash flow contribution.
• Risk mitigation involves managing regulatory compliance and maintaining key customer relationships.

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FAQs

1. What is the primary market for RIMSO-50?
   North America accounts for approximately 45% of demand, followed by Europe and Asia-Pacific.

2. How does patent expiration affect RIMSO-50?
   Patent expiration has led to increased generic competition, pressuring prices and margins.

3. What are the main safety concerns with iodinated contrast agents?
   Risks include contrast-induced nephropathy and allergic reactions; regulators monitor ongoing safety data.

4. Can RIMSO-50 expand into new indications?
   Currently, its use is limited to diagnostic imaging; expansion would require regulatory approval for new indications.

5. What is the future outlook for contrast media?
   Growth is driven by increased imaging procedures, but competition from alternative agents and innovation poses challenges.

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Citations
[1] IQVIA, "Global Contrast Media Market Report," 2022.
[2] Bracco Diagnostics, "Annual Report," 2022.
[3] MarketsandMarkets, "Contrast Media Market by Type," 2023.