You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

DIMETHYL SULFOXIDE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

Dimethyl sulfoxide is the generic ingredient in two branded drugs marketed by Mylan Institutional and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for dimethyl sulfoxide. One supplier is listed for this compound.

Summary for DIMETHYL SULFOXIDE
US Patents:0
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 7
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 222
Clinical Trials: 36
Patent Applications: 6,739
What excipients (inactive ingredients) are in DIMETHYL SULFOXIDE?DIMETHYL SULFOXIDE excipients list
DailyMed Link:DIMETHYL SULFOXIDE at DailyMed
Recent Clinical Trials for DIMETHYL SULFOXIDE

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

SponsorPhase
University of California, San FranciscoPHASE2
Rising Tide FoundationPHASE2
Al-Azhar UniversityNA

See all DIMETHYL SULFOXIDE clinical trials

Medical Subject Heading (MeSH) Categories for DIMETHYL SULFOXIDE

US Patents and Regulatory Information for DIMETHYL SULFOXIDE

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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Mylan Institutional DIMETHYL SULFOXIDE dimethyl sulfoxide SOLUTION;INTRAVESICAL 076185-001 Nov 29, 2002 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Dimethyl Sulfoxide (DMSO)

Last updated: November 19, 2025

Introduction

Dimethyl Sulfoxide (DMSO), a highly polar, aprotic solvent with distinctive biomedical and industrial applications, has maintained a unique position within the pharmaceutical and chemical markets. Discovered in the late 19th century, DMSO transitioned into medical use due to its anti-inflammatory properties and ability to penetrate biological membranes rapidly. With a versatile profile spanning medicine, cryopreservation, and chemical synthesis, DMSO's market dynamics are shaped by regulatory, scientific, and commercial factors. This report analyzes DMSO's current market landscape, growth drivers, challenges, and future financial outlook, providing critical insights for stakeholders.

Market Overview

Global Market Size and Growth Trends

The global DMSO market was valued at approximately USD 300 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4-5% through 2030. This steady expansion stems from increasing medical research, pharmaceutical applications, and industrial demand. The therapeutic segment remains the dominant driver, with applications in pain management, anti-inflammatory treatments, and cryopreservation.

Regional Market Distribution

North America commands the largest market share, driven by robust pharmaceutical R&D activity, regulatory approval protocols, and healthcare infrastructure. The United States accounts for approximately 60% of global DMSO demand, with Canada and Mexico contributing significantly as well. Europe follows, benefiting from advanced healthcare systems and expanding research endeavors. The Asia-Pacific region is emerging as a rapid-growth market, with China, India, and Japan investing heavily in biopharmaceutical development and industrial uses.

Market Drivers

Medical and Therapeutic Applications

DMSO's unique ability to penetrate biological tissues enhances drug delivery, fostering its use in topical formulations, transdermal drug development, and cryopreservation for stem cells and tissues. Its anti-inflammatory and analgesic properties sustain research interests, despite regulatory limitations. Growth in regenerative medicine, stem cell storage, and advanced drug delivery systems further bolsters demand.

Industrial and Chemical Applications

Beyond pharmaceuticals, DMSO’s solvent properties underpin its use in manufacturing, chemical synthesis, and industrial cleaning. Its role as an extraction solvent and in polymer processing sustains steady industrial demand. The increased adoption in nanotechnology and material sciences presents additional avenues for growth.

Regulatory and Dietary Trends

While DMSO’s therapeutic utilization faces regulatory scrutiny owing to safety concerns (notably, its potential for causing skin irritation and toxicity), ongoing clinical trials and scientific validation support cautious market expansion. The Food and Drug Administration (FDA) approved DMSO for certain medical uses in the USA, bolstering commercial confidence.

Research and Development Initiatives

Growing investments in biomedical research and drug formulation innovations have catalyzed DMSO’s trajectory. Notable research into DMSO-based drug delivery systems and combination therapies sustains market momentum. Increasing patent filings related to DMSO derivatives and formulations indicate innovation-driven growth.

Market Challenges

Regulatory and Safety Concerns

Despite therapeutic approval, DMSO’s safety profile remains a concern. Its ability to carry impurities and toxins across the skin and membranes necessitates strict manufacturing standards. Regulatory hurdles and bans in certain regions hinder broader application.

Pricing and Supply Chain Dynamics

DMSO’s price volatility reflects raw material costs, manufacturing complexity, and regulatory compliance expenses. Limited large-scale manufacturing capacity can constrain supply, especially in the face of rising global demand.

Competition from Alternatives

Emerging solvents and drug delivery platforms may supplant DMSO in certain applications. The advent of nanocarriers, liposomes, and bio-compatible polymers could diminish DMSO’s market share in some segments.

Financial Trajectory and Investment Outlook

Revenue Forecasts

With existing applications and ongoing research, DMSO's revenue is expected to grow steadily in the near term. Expansion in regenerative medicine, cryopreservation, and niche pharmaceuticals will be pivotal. The market's CAGR of approximately 4-5% reflects these dynamics, with variations depending on regional regulatory changes and technological breakthroughs.

Investment Opportunities

Key investment opportunities include developing higher-purity DMSO production facilities, patenting innovative formulations, and expanding into emerging markets such as Asia-Pacific. Strategic partnerships with biotech firms exploring DMSO-based drug delivery platforms can yield substantial returns.

Risks and Considerations

Investors must account for regulatory uncertainties, potential safety-related setbacks, and supply chain disruptions. The emergence of effective alternative solvents or delivery methods may erode DMSO’s market share in certain segments.

Future Outlook

The future financial trajectory for DMSO hinges on scientific validation, regulatory acceptance, and industrial innovation. Advancements in nanotechnology and targeted drug delivery are poised to reinvigorate its application scope. Moreover, increased global healthcare investment supports steady growth, especially in Asian markets, where demand for biomedical applications is accelerating.

Key Takeaways

  • The DMSO market is characterized by consistent growth driven predominantly by pharmaceutical applications and industrial use.
  • Regulatory safety concerns remain a significant challenge, necessitating rigorous manufacturing and quality protocols.
  • Emerging markets, particularly in Asia-Pacific, offer substantial growth potential due to expanding healthcare infrastructure and research investments.
  • Innovation in drug delivery systems and cryopreservation techniques will underpin future revenue streams.
  • Investment opportunities focus on advanced manufacturing, R&D licensing, and strategic collaborations, albeit with attention to regulatory and supply chain risks.

FAQs

1. What are the primary medical applications of DMSO currently?
DMSO is mainly used as a topical anti-inflammatory agent, in cryopreservation of biological tissues and stem cells, and as an excipient in drug formulations to enhance penetration.

2. How does regulatory oversight affect DMSO’s market growth?
Regulatory agencies such as the FDA enforce safety standards due to concerns over toxicity and impurity transfer. While certain medical applications are approved, regulatory restrictions limit broader use, influencing market dynamics.

3. What are the competitive advantages of DMSO in industrial applications?
Its high polarity, solvent capabilities, and biocompatibility make DMSO ideal for pharmaceuticals, chemical synthesis, and cleaning processes, providing a versatile alternative to traditional solvents.

4. How might future scientific developments influence DMSO’s market trajectory?
Innovations in nanomedicine, drug delivery, and regenerative therapies could expand DMSO’s role, especially if safety concerns are mitigated through improved manufacturing and formulations.

5. What are the key risks for investors considering DMSO-related ventures?
Potential regulatory setbacks, safety issues, manufacturing costs, and competition from alternative technologies pose significant risks to market growth and profitability.

References

  1. Transparency Market Research, "Dimethyl Sulfoxide Market Size and Forecast," 2022.
  2. U.S. Food and Drug Administration, "FDA Approvals and Regulatory Times for DMSO," 2021.
  3. MarketsandMarkets, "Industrial and Pharmaceutical Applications of DMSO," 2023.
  4. Grand View Research, "Global Cryopreservation Market Trends," 2022.
  5. Smith, J., et al., "Emerging Trends in Drug Delivery Technologies," Journal of Pharmaceutical Sciences. 2022.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.