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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	222
Patent Applications:	3,842
Drug Prices:	Drug price information for RIMSO-50
What excipients (inactive ingredients) are in RIMSO-50?	RIMSO-50 excipients list
DailyMed Link:	RIMSO-50 at DailyMed

See drug prices for RIMSO-50

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

Expired US Patents for RIMSO-50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Institutional	RIMSO-50	dimethyl sulfoxide	SOLUTION;INTRAVESICAL	017788-001	Approved Prior to Jan 1, 1982

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
France	4169
Netherlands	140731
Belgium	644614
United Kingdom	1106169
Canada	1001075	PHARMACEUTICAL COMPOSITIONS CONTAINING DIALKYL SULFOXIDES

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
2441753	SPC/GB17/036	United Kingdom		PRODUCT NAME: ALECTINIB (9-ETHYL-6,6-DIMETHYL-8-(4-MORPHOLIN-4-YL-PIPERIDIN-1-YL)-11-OXO-6,11-DIHYDRO-5H-BENZO(B)CARBAZOLE-3-CARBONITRILE) OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/16/1169 (NI) 20170220; UK PLGB 00031/0843 20170220
0284288	SPC/GB98/002	United Kingdom		PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730
2653873	LUC00294	Luxembourg		PRODUCT NAME: DIMETHYL FUMARATE (TECFIDERA); AUTHORISATION NUMBER AND DATE: EU/1/13/837/001-002 20140203
2137537	PA2014024	Lithuania		PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2653873	2023C/501	Belgium		PRODUCT NAME: FUMARATE DE DIMETHYLE; AUTHORISATION NUMBER AND DATE: EU/1/13/837 20140203

Market Dynamics and Financial Trajectory for RIMSO-50

Last updated: July 28, 2025

Introduction

RIMSO-50, known generically as dimethyl sulfoxide (DMSO) 50%, is a pharmaceutical agent chiefly utilized for the treatment of interstitial cystitis (IC), a chronic bladder condition characterized by pelvic pain, urgency, and frequency. Currently marketed by NovaBay Pharmaceuticals under the brand name RIMSO-50, its market landscape is influenced by regulatory pathways, evolving medical needs, competitive alternatives, and manufacturing factors. This analysis explores the underlying drivers shaping the current market dynamics and projects the financial trajectory for RIMSO-50 over the coming years.

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Market Overview and Key Drivers

Medical Unmet Needs and Therapeutic Positioning

Interstitial cystitis affects approximately 3 to 8 million women and 1 to 4 million men in the United States alone, with a significant subset of patients resistant to conventional therapies. RIMSO-50 operates as an intravesical therapy that inhibits inflammation and provides symptomatic relief. Its advantage stems from its minimally invasive delivery and an established safety profile (Fitzgerald et al., 2019). Nonetheless, limited dissemination and awareness, coupled with competition from novel treatments, influence its market penetration.

Regulatory Landscape

The FDA approved RIMSO-50 in 1980, marking its long-standing presence. Existing approvals serve as a barrier and an entry point for potential expansion. Such historic approval allows for accelerated pathways if supplemental indications are sought. Recently, there is increased interest in repositioning older drugs like RIMSO-50 for off-label uses or additional indications, contingent on successful clinical development and regulatory approval.

Competitive Environment

RIMSO-50 faces competition from:

• Oral medications: such as pentosan polysulfate sodium (Elmiron), which is widely used but faces concerns over safety and efficacy.
• Bladder instillations: like hyaluronic acid, chondroitin sulfate, and combination therapies.
• Interventional procedures: including sacral nerve stimulation and neuromodulation.
• Emerging biological therapies: including monoclonal antibodies addressing inflammatory pathways.

The competitive landscape is intensifying with the innovation of biologics and minimally invasive therapies. However, RIMSO-50 maintains a niche due to its demonstrated safety profile and historical presence.

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Market Dynamics Influencing RIMSO-50

Pricing and Reimbursement Factors

Pricing strategies significantly influence RIMSO-50’s market penetration. As an injectable intravesical agent, its cost per treatment cycle remains relatively fixed, yet reimbursement policies vary across regions. International markets, particularly in Europe and Asia, display divergent reimbursement frameworks, affecting sales volume. The US Medicare and private insurers' coverage policies toward intravesical agents impact accessibility and adoption rates.

Manufacturing and Supply Chain Considerations

Manufacturing complexities related to the sterile preparation of RIMSO-50 and its shelf-life influence supply stability. Potential shortages or price fluctuations due to raw material costs—particularly for high-quality DMSO—can impact market stability. Patent expirations and alternative sourcing further modulate supply chain resilience.

Market Penetration and Physician Adoption

Physician familiarity with RIMSO-50 and clinical guidelines impact adoption levels. Awareness campaigns and evidence from clinical trials that further validate efficacy can improve prescribing habits. Conversely, emerging therapies with better convenience or perceived efficacy threaten the existing market share.

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Financial Trajectory and Market Projections

Historical Sales Performance

Since its FDA approval in 1980, RIMSO-50 has seen periodic sales, primarily driven by a dedicated niche of urologists. Recent data indicate stagnation owing to limited awareness and competition, with anecdotal reports of modest growth in specific regions due to increased clinical advocacy.

Forecasting Future Revenue Streams

Assuming targeted strategies—such as clinical research expansion, targeted marketing, and geographic expansion—the following projections are plausible:

• Short-term (1–3 years): Slow growth, primarily driven by increased physician education and localized marketing efforts. Projected annual revenue growth of approximately 3–5%.
• Medium-term (4–7 years): Potential expansion into additional indications, especially if clinical trials demonstrate efficacy in other inflammatory bladder conditions, driving revenue growth of 10–15%.
• Long-term (8+ years): Market saturation likely without significant innovation; growth may plateau or decline unless new formulations or indications are developed.

Impact of Clinical Development and Regulatory Strategies

Expansion into new indications (e.g., radiation cystitis or neurogenic bladder) through clinical trials can diversify revenue sources. Successful FDA or international regulatory approvals would notably boost market confidence and valuation.

Competitive and Market Risks

Factors risking favorable financial outcome include:

• Disruption by novel therapies offering improved efficacy or convenience.
• Stringent reimbursement policies.
• Patent challenges or the emergence of biosimilars.
• Changes in healthcare policy affecting drug pricing and access.

Potential Uptake via Strategic Collaborations

Partnerships with healthcare providers, research institutions, and pharmaceutical firms could accelerate clinical development, enhance market reach, and optimize manufacturing.

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Conclusion

RIMSO-50 exists in a niche but potentially expanding segment of the urology therapeutics market. Its robust safety profile and established clinical application underpin its resilience, yet growth is tempered by increasing competition and limited awareness. The financial trajectory hinges on strategic market penetration, clinical validation for additional indications, and regulatory facilitation. A cautious yet optimistic outlook suggests modest growth over the next decade with targeted efforts; however, without innovation or expanded indications, market share risks stagnation.

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Key Takeaways

• RIMSO-50’s market stability depends on physician awareness, clinical validation, and reimbursement policies.
• Expansion into new indications through clinical trials offers significant upside potential.
• Competitive dynamics, especially from emerging biologics and innovative therapies, pose risks.
• Manufacturing and supply chain considerations influence pricing and availability.
• Strategic partnerships and regulatory navigation are critical for enhancing market share and financial performance.

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FAQs

1. What is the primary indication for RIMSO-50?
RIMSO-50 is primarily used for the intravesical treatment of interstitial cystitis, providing symptomatic relief by reducing bladder inflammation.

2. How does RIMSO-50 compare to other cystitis treatments?
Compared to oral agents like pentosan polysulfate, RIMSO-50 offers direct bladder instillation, which can lead to better localized effects and fewer systemic side effects, though it involves a more invasive administration route.

3. What are the main barriers to growth for RIMSO-50?
Limited awareness among physicians, competition from emerging therapies, reimbursement challenges, and the absence of new indications hinder accelerated growth.

4. Are there opportunities for RIMSO-50 in international markets?
Yes. Markets in Europe and Asia show potential given differing healthcare policies and unmet needs, especially if regulatory approvals are secured and awareness campaigns are executed.

5. What strategies could enhance RIMSO-50’s financial prospects?
Expanding clinical research for additional indications, building strategic alliances, improving manufacturing efficiency, and targeted marketing efforts could bolster its market position.

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Sources:
[1] Fitzgerald MP, et al. "Treatment options for interstitial cystitis." J Urol. 2019;202(1):27-33.