List of Excipients in Branded Drug DIMETHYL SULFOXIDE

Generic Drugs Containing DIMETHYL SULFOXIDE

Company	Ingredient	NDC	Excipient
Renova Pharmaceuticals LLC	dimethyl sulfoxide	84897-052	WATER

What are the Most Frequently-Used Excipients in DIMETHYL SULFOXIDE?

# Of NDCs	Excipient
1	WATER

Dimethyl Sulfoxide Excipient Strategy and Pharmaceutical Commercial Opportunities

Last updated: August 4, 2026

Dimethyl sulfoxide, or DMSO, has two distinct pharmaceutical roles: it is the active ingredient in the FDA-approved intravesical product RIMSO-50 and a high-value solvent, cryoprotectant, and processing excipient in drug, biologic, cell-therapy, and gene-therapy manufacturing. The strongest commercial opportunities are in GMP-grade supply, validated low-residual formulations, cryopreservation systems, and specialty drug-delivery platforms. The basic DMSO molecule has no meaningful composition-of-matter exclusivity opportunity; commercial defensibility depends on purity, manufacturing controls, formulation performance, regulatory documentation, and application-specific patents.

What pharmaceutical products contain dimethyl sulfoxide?

DMSO is used in pharmaceutical products as an active drug, solvent, penetration enhancer, cryoprotectant, and processing aid.

Use	Pharmaceutical role	Commercial status
RIMSO-50	Active ingredient in a 50% intravesical solution	FDA-approved prescription product for interstitial cystitis
Small-molecule formulation	Solvent or cosolvent for poorly water-soluble compounds	Broad use, subject to route and exposure limits
Cell therapy	Cryoprotectant during freezing and thawing	Established use in cell-processing systems
Gene therapy	Cryoprotectant or process aid for cellular starting materials and intermediates	Growing use in advanced therapy manufacturing
Topical formulations	Penetration enhancer and solvent	Regulatory and safety constraints are significant
Research and development	Solvent for screening compounds, APIs, and biological materials	Large nonclinical and laboratory market
Manufacturing	Process solvent and cleaning or recovery aid	Requires GMP control when used in drug manufacture

RIMSO-50 contains 50% DMSO in a sterile aqueous solution for intravesical administration. Its FDA-approved indication is symptomatic relief of interstitial cystitis. DMSO is not broadly approved as a systemic therapeutic drug merely because it is listed as an excipient in other products. Each finished product must establish safety, quality, and suitability for its proposed route of administration. [1]

What is the FDA regulatory status of dimethyl sulfoxide?

DMSO has FDA-approved drug status through RIMSO-50, but its regulatory treatment depends on whether it is the active ingredient or an inactive ingredient.

Active ingredient status

RIMSO-50 is the principal U.S. reference product for pharmaceutical DMSO as an active ingredient. The product is a sterile 50% DMSO solution administered directly into the bladder. Its approval does not establish approval for oral, injectable, ophthalmic, inhaled, or systemic DMSO products.

A new DMSO product using a different route, concentration, indication, or formulation would generally require an appropriate FDA pathway. The regulatory burden would depend on whether the product qualifies as:

• An ANDA referencing an approved product.
• A 505(b)(2) application relying partly on published or existing FDA findings.
• A full 505(b)(1) NDA supported by new clinical and nonclinical data.
• An investigational product used in a cell or gene-therapy manufacturing process rather than administered directly to patients.

Inactive ingredient status

DMSO appears in FDA inactive-ingredient and excipient reference systems for certain routes and dosage forms. Those listings are not blanket approvals. The listed route, dosage form, concentration, and maximum exposure are relevant to a regulatory assessment. A sponsor using DMSO in a new dosage form must address local tolerance, systemic exposure, residual DMSO, impurity control, container compatibility, and manufacturing reproducibility. [2]

What excipient strategy should pharmaceutical companies use for DMSO?

The most defensible strategy is to treat DMSO as a critical material rather than a commodity solvent.

Use pharmaceutical or GMP grade

Commercial DMSO may be available at very high chemical purity, but pharmaceutical development requires a broader control package:

• Identity and assay.
• Water content.
• Acidity or alkalinity.
• Oxidation products, including dimethyl sulfone.
• Residual solvents and volatile impurities.
• Trace metals.
• Microbial quality.
• Endotoxin, where applicable.
• Bioburden and sterility controls for sterile applications.
• Container-closure compatibility.
• Full change-control and supply-continuity documentation.

A pharmaceutical customer should qualify the supplier under a quality agreement and maintain an approved specification tailored to the dosage form and route of administration.

Control water content

DMSO is hygroscopic. Water uptake can affect viscosity, freezing behavior, solubility, crystallization, process performance, and the concentration of the final product. The issue is particularly important in:

• Cryopreservation solutions.
• High-concentration topical products.
• DMSO-based injectable formulations.
• Low-temperature manufacturing processes.
• Analytical standards and reference formulations.

Moisture limits should be linked to product performance rather than treated as a purely chemical specification.

Manage oxidation and degradation

DMSO can oxidize to dimethyl sulfone under suitable conditions. The sponsor should establish degradation pathways under heat, light, oxygen exposure, and repeated container opening. Compatibility studies should cover:

• Stainless steel.
• Glass.
• High-density polyethylene.
• Polypropylene.
• Elastomeric closures.
• Single-use bioprocessing bags.
• Tubing and connectors.

The strong solvent properties of DMSO can increase extractables and leachables from polymeric systems. The effect is relevant to both drug products and cell-processing materials.

Treat odor and patient acceptability as product attributes

DMSO has a distinctive odor and may produce a garlic-like taste or odor after administration. That characteristic can affect adherence and patient acceptance, particularly in repeated-use products. Odor control cannot rely on masking agents without a compatibility and safety assessment. Packaging, concentration, route, and dosing frequency may offer better commercial solutions.

What formulations are protected by dimethyl sulfoxide patents?

The basic DMSO molecule is old and cannot support new composition-of-matter exclusivity. Patent value lies in specific applications, combinations, delivery systems, and manufacturing processes.

Potentially protectable categories include:

Patent category	Examples of claim focus	Commercial value
Pharmaceutical composition	DMSO combined with a specific API, buffer, surfactant, or stabilizer	Moderate to high if the formulation solves a defined stability or solubility problem
Method of treatment	Use of DMSO for a defined disease, dose, route, or patient population	Variable; vulnerable to prior-art and enablement challenges
Drug delivery	DMSO-assisted transdermal or mucosal delivery	Potentially high, but safety and reproducibility are central
Cryopreservation	DMSO concentration, cooling rate, additives, or thawing protocol	High in cell and gene therapy if linked to a validated process
Manufacturing	DMSO-based API isolation, purification, or crystallization	Usually process-specific and difficult to enforce against independent manufacturing
Container system	Packaging that limits water uptake, leachables, or oxidation	Useful as a secondary protection layer
Combination therapy	DMSO with an active agent for local inflammation, pain, or tissue injury	Commercial value depends on clinical differentiation

Patent claims that merely recite DMSO as a solvent or conventional cryoprotectant face substantial novelty and obviousness challenges. Stronger claims usually require a defined concentration range, a specific cell type, a measurable viability or potency improvement, a particular processing sequence, or a clinically meaningful outcome.

How strong is the dimethyl sulfoxide patent estate?

The core DMSO patent estate is weak because the compound, its chemical identity, and many solvent uses are long established. The application-specific estate can still be commercially relevant.

Patent strength by asset type

Asset	Expected strength	Main vulnerability
DMSO composition of matter	Very low	Expired prior art
DMSO as a general solvent	Low	Extensive published use
DMSO in RIMSO-50-type intravesical therapy	Low for basic composition	Age of product and extensive prior art
Defined DMSO/API formulation	Moderate	Obviousness and routine formulation optimization
Cell-therapy cryopreservation process	Moderate to high	Prior protocols and difficulty proving infringement
Validated low-residual DMSO process	Moderate	Enablement and measurable-performance requirements
Proprietary container and delivery system	Moderate	Design-around risk
DMSO-enabled topical or mucosal delivery platform	Moderate	Safety, prior art, and clinical reproducibility

Patent owners should build protection around a product platform rather than DMSO alone. A portfolio can combine formulation claims, process claims, method-of-use claims, analytical methods, and container-closure claims. Trade secrets are important for supplier qualification, mixing order, cooling profiles, thawing conditions, and impurity-control methods that are difficult to reverse engineer.

What patents protect RIMSO-50 and when does it lose exclusivity?

RIMSO-50 is an old small-molecule product. Its commercial protection is primarily regulatory history, manufacturing capability, brand recognition, and physician familiarity rather than surviving basic compound patents.

Item	RIMSO-50 position
Active ingredient	Dimethyl sulfoxide
Strength	50%
Dosage form	Sterile intravesical solution
Indication	Symptomatic relief of interstitial cystitis
FDA pathway	NDA
Reference product	RIMSO-50
Core compound patent	No commercially meaningful remaining protection
Biologic exclusivity	Not applicable
Generic pathway	ANDA may be available if sameness and other requirements are met
Current commercial defense	Manufacturing quality, distribution, labeling, and market familiarity

The FDA Orange Book should be checked for current patent and exclusivity entries associated with the reference NDA. Because RIMSO-50 was approved decades ago, statutory new-drug exclusivity is no longer a material barrier. Any current commercial protection would need to arise from listed patents, manufacturing differentiation, contractual distribution, or brand economics rather than the original approval date. [3]

What Paragraph IV challenges and generic entry risks exist for DMSO products?

DMSO products have generic-entry risk because the active ingredient is well known, the dosage form is relatively simple, and the main branded product is old.

A prospective ANDA applicant would need to address:

• Active ingredient sameness.
• Concentration and dosage-form equivalence.
• Sterility assurance.
• In-use stability.
• Container-closure performance.
• Labeling and indication requirements.
• Impurities and degradation products.
• Local bladder tolerability.
• Any listed patents in the Orange Book.

A Paragraph IV certification would be relevant only if the reference product has a listed patent that the applicant seeks to invalidate or avoid. If the reference product has no blocking listed patent, the applicant would normally rely on other ANDA certification routes. A timely Paragraph IV notice can trigger a 30-month stay if the patent holder brings suit within the statutory period, but that mechanism has limited practical relevance when the listed-patent estate is empty or expired. [4]

Generic launch scenarios

Scenario	Likely commercial effect
No blocking patent and successful ANDA approval	Rapid price competition in a niche market
ANDA approval with manufacturing differentiation	Moderate erosion of branded share
505(b)(2) product with a new route or indication	Limited direct substitution but higher development cost
New DMSO formulation with clinical differentiation	Potential premium pricing and stronger patent position
Cell-therapy grade DMSO supply contract	Lower substitution risk due to validation and change-control costs

Does DMSO create biosimilar risk?

No. DMSO is a synthetic small molecule and is not a biologic. Biosimilar pathways do not apply to DMSO or RIMSO-50.

The relevant competitive threats are:

• Generic DMSO drug products.
• Alternative intravesical therapies.
• Non-DMSO cryoprotectants.
• DMSO-free cell-preservation formulations.
• Other solvents and solubilization technologies.
• Proprietary single-use manufacturing systems.

In cell and gene therapy, the principal risk is not biosimilar substitution. It is process substitution. Sponsors may move from DMSO-containing cryopreservation media to DMSO-reduced or DMSO-free systems to reduce toxicity, improve post-thaw recovery, simplify administration, or address regulatory expectations for residual solvent control.

What are the strongest commercial opportunities for pharmaceutical-grade DMSO?

Cell and gene therapy manufacturing

DMSO is widely used in cryopreservation of cells, tissues, and cellular intermediates. The commercial opportunity is stronger in validated GMP supply than in raw-material sales alone.

High-value offerings include:

• Qualified GMP DMSO in sterile, single-use containers.
• Low-endotoxin and low-bioburden grades.
• Premeasured DMSO for closed-system processing.
• DMSO-containing cryopreservation media.
• Low-residual DMSO formulations.
• Stability-indicating analytical packages.
• Technical support for freezing and thawing validation.
• Lot traceability and supply continuity.

DMSO suppliers can increase switching costs through customer-specific qualification, regulatory support, and integration with automated cell-processing systems.

Specialty drug delivery

DMSO can improve solubility and tissue penetration, but penetration enhancement also increases the risk of unintended systemic exposure and local irritation. The best targets are localized products where the exposure benefit is measurable and clinically relevant.

Potential areas include:

• Topical analgesic and anti-inflammatory products.
• Dermatologic delivery of poorly soluble APIs.
• Mucosal delivery.
• Localized depot systems.
• Ex vivo tissue treatment.
• Veterinary drug delivery.

Commercial success requires evidence that DMSO improves exposure, dose uniformity, or clinical performance without creating unacceptable tolerability or packaging problems.

Injectable and parenteral formulations

DMSO can dissolve compounds that are poorly soluble in water. Its use in injectable products is constrained by toxicity, tolerability, residual-solvent limits, hemolysis risk, precipitation during dilution, and container compatibility.

The strongest strategy is to use the minimum effective concentration and combine DMSO with other solubilization technologies, such as:

• Cosolvent systems.
• Cyclodextrins.
• Surfactants.
• Lipid nanoparticles.
• Polymer-based dispersions.
• pH-controlled formulations.

A formulation that reduces DMSO exposure while maintaining solubility can support both regulatory differentiation and patentability.

Research and development supply

R&D-grade DMSO is a large but lower-margin business. Pharmaceutical-grade and cell-therapy-grade products command stronger customer retention because replacement requires method transfer, comparability work, and process requalification.

Which companies are challenging DMSO products?

The competitive field is fragmented. Generic-drug manufacturers can challenge RIMSO-50 through an ANDA, while specialty chemical suppliers compete for excipient and bioprocessing contracts. Cell-therapy companies also develop DMSO-reduced or DMSO-free cryopreservation systems.

No biologic sponsor or biosimilar manufacturer is a direct challenger to DMSO. Competitive intensity is highest in:

• Sterile excipient supply.
• Cell-processing media.
• Cryopreservation systems.
• Topical drug delivery.
• Contract manufacturing of cell therapies.
• Specialty chemical distribution.

Supplier differentiation depends on GMP status, regulatory documentation, sterile-fill capability, packaging, lot consistency, and global supply resilience.

What manufacturing and intellectual-property barriers affect DMSO commercialization?

DMSO synthesis itself is established and relatively accessible. The practical barriers are quality and application control.

Manufacturing barriers

Key barriers include:

• Consistent removal of trace impurities.
• Control of water and oxidation products.
• Sterile filtration or aseptic filling.
• Low-endotoxin production.
• Compatibility with single-use systems.
• Container-closure integrity.
• Temperature-controlled logistics where required.
• Multi-site supply qualification.
• Documentation for global regulatory filings.

Intellectual-property barriers

The most relevant IP risks arise from customer-specific applications rather than DMSO supply. A supplier can encounter claims covering:

• A defined cryopreservation composition.
• A cell-processing sequence.
• A DMSO concentration range.
• A thawing protocol.
• A DMSO-reduction step.
• A particular delivery device.
• A combination of DMSO and an active pharmaceutical ingredient.

Freedom-to-operate reviews should focus on the end-use application, not only on DMSO chemical patents.

How does DMSO compare with alternative excipients and cryoprotectants?

Material	Main advantage	Main limitation
DMSO	Strong solvent and established cryoprotectant	Odor, toxicity, residual-solvent concerns
Glycerol	Useful cryoprotectant for selected systems	Less suitable for many clinical cell products
Ethylene glycol	Effective in some cryopreservation applications	Toxicity and regulatory limitations
Propylene glycol	Solvent and cosolvent utility	Route-dependent tolerability
Hydroxyethyl starch	Supports some cell-preservation systems	Product-specific regulatory and process limitations
Trehalose	Can reduce DMSO dependence and stabilize membranes	Often requires specialized delivery or process conditions
Cyclodextrins	Improve aqueous solubility	May create dose, toxicity, or formulation-complexity issues
Lipid and polymer systems	Can reduce solvent exposure	Higher manufacturing and characterization burden

DMSO remains attractive where performance is proven and process familiarity is valuable. Its position is weaker where residual exposure, patient tolerability, or administration logistics dominate the product decision.

What is the revenue exposure for DMSO-based pharmaceutical products?

Revenue exposure varies sharply by segment.

Segment	Revenue profile	Erosion risk
RIMSO-50	Niche prescription revenue	High if a substitutable generic enters
Bulk industrial DMSO	Volume-driven and lower margin	High commodity exposure
Pharmaceutical-grade excipient	Moderate margin with qualification value	Moderate
Sterile GMP DMSO	Higher margin and stronger retention	Lower after validation
Cell-therapy cryopreservation media	High strategic value	Moderate, with DMSO-free substitution risk
Proprietary DMSO formulation	Potential premium pricing	Depends on clinical differentiation
Contract manufacturing support	Service revenue and switching costs	Lower if embedded in validated workflows

The best investment thesis is usually not commodity DMSO production. It is an integrated platform combining high-purity material, sterile packaging, analytical testing, regulatory support, and validated use in advanced therapies.

What licensing deals involve dimethyl sulfoxide?

DMSO itself is generally a low-royalty chemical input rather than a major licensing asset. Publicly disclosed commercial value is more likely to arise from:

• Licensing a DMSO-containing formulation.
• Partnering on a cryopreservation medium.
• Supplying qualified material under a long-term agreement.
• Providing manufacturing know-how.
• Supporting a cell-therapy process under a quality or technology-transfer agreement.
• Licensing a DMSO-reduction or DMSO-free preservation platform.

A DMSO supplier should prioritize supply agreements, co-development arrangements, and process-validation partnerships over molecule-level licensing. A drug developer should avoid relying on DMSO as the sole inventive concept and instead license the broader formulation or delivery technology.

What is the geographic coverage of DMSO pharmaceutical opportunities?

The United States has the clearest reference-product pathway through RIMSO-50 and FDA excipient systems. Europe, Japan, and other regulated markets evaluate DMSO according to local medicinal-product, excipient, residual-solvent, and advanced-therapy requirements.

Geographic expansion is most attractive for:

• Cell and gene therapy manufacturing hubs.
• Contract development and manufacturing organizations.
• Sterile injectable manufacturers.
• Specialty topical-drug developers.
• Cryopreservation suppliers.
• Research-use and bioprocessing distributors.

Global protection depends less on core DMSO patents and more on local formulation, process, delivery-device, and method-of-use filings. Patent term should be analyzed separately in the United States, Europe, Japan, China, and other target jurisdictions because application-specific patents may have different filing dates, prosecution outcomes, and enforceability.

Key Takeaways

• DMSO is both an FDA-approved active ingredient in RIMSO-50 and a widely used pharmaceutical excipient.
• The basic DMSO molecule has no meaningful remaining composition-of-matter exclusivity.
• RIMSO-50 is an old, niche product with generic-entry exposure and limited regulatory exclusivity.
• The strongest commercial opportunity is GMP-grade, sterile, validated DMSO for cell and gene therapy manufacturing.
• Formulation patents are more defensible when they demonstrate a specific performance benefit rather than merely reciting DMSO.
• DMSO-free and DMSO-reduced cryopreservation systems are the principal technology threat.
• Supplier value comes from quality systems, low residuals, packaging, regulatory documentation, and process integration.
• Biosimilar risk does not apply; generic and process-substitution risk does.
• DMSO should be protected through application-specific patents, trade secrets, and long-term supply relationships.

FAQs

Is dimethyl sulfoxide an FDA-approved excipient?

DMSO has FDA-recognized use in pharmaceutical products, but excipient acceptability is route-, dosage-form-, concentration-, and exposure-dependent. DMSO is also the active ingredient in the approved drug RIMSO-50.

Can a company patent a DMSO formulation?

Yes. A company may patent a novel DMSO-containing formulation, combination, delivery system, manufacturing method, or therapeutic use. A claim directed only to DMSO as a general solvent is unlikely to provide meaningful protection.

Is RIMSO-50 protected by an active patent?

RIMSO-50 is an old product, and its original regulatory exclusivity has expired. Current Orange Book entries, if any, determine whether a listed patent creates a formal ANDA barrier. Basic DMSO composition patents do not provide current protection.

Why is DMSO used in cell therapy?

DMSO protects cells during freezing by reducing ice-related cellular injury. Its use is established, but sponsors must control residual DMSO because exposure can affect tolerability and product administration.

What is the main commercial risk for pharmaceutical DMSO suppliers?

The main risk is substitution by DMSO-reduced or DMSO-free cryopreservation systems, combined with commodity pricing pressure. Suppliers with sterile GMP manufacturing, validated packaging, and regulatory support have stronger defenses than bulk chemical vendors.

References

1. U.S. Food and Drug Administration. (n.d.). RIMSO-50 (dimethyl sulfoxide) irrigation, 50% prescribing information. FDA.
2. U.S. Food and Drug Administration. (n.d.). Inactive ingredient database. FDA.
3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. FDA.
4. U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application submissions: Refuse-to-receive standards. FDA.
5. International Council for Harmonisation. (2021). ICH Q3C(R8): Impurities: Guideline for residual solvents. ICH.
6. United States Pharmacopeia. (2024). Dimethyl sulfoxide monograph. United States Pharmacopeial Convention.
7. European Medicines Agency. (2018). Guideline on the quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells. EMA.