List of Excipients in Branded Drug CLODAN

Generic Drugs Containing CLODAN

Company	Ingredient	NDC	Excipient
Medimetriks Pharmaceuticals	clobetasol propionate	43538-950	ALCOHOL
Medimetriks Pharmaceuticals	clobetasol propionate	43538-950	COCO-BETAINE
Medimetriks Pharmaceuticals	clobetasol propionate	43538-950	HYDROCHLORIC ACID
Medimetriks Pharmaceuticals	clobetasol propionate	43538-950	POLYQUATERNIUM-10
Medimetriks Pharmaceuticals	clobetasol propionate	43538-950	SODIUM LAURETH-3 SULFATE
Medimetriks Pharmaceuticals	clobetasol propionate	43538-950	WATER

What are the Most Frequently-Used Excipients in CLODAN?

# Of NDCs	Excipient
1	ALCOHOL
1	COCO-BETAINE
1	HYDROCHLORIC ACID
1	POLYQUATERNIUM-10
1	SODIUM LAURETH-3 SULFATE
1	WATER

CLODAN Excipient Strategy and Commercial Opportunities

Last updated: August 23, 2026

CLODAN is a prescription topical shampoo containing clobetasol propionate 0.05% for short-term treatment of moderate-to-severe scalp psoriasis in adults. Its commercial value is driven less by the mature active ingredient and more by vehicle performance: scalp deposition, wash-off control, tolerability, cosmetic acceptability, manufacturing robustness, and differentiation from lotions, solutions, foams, and conventional shampoos.

The strongest opportunities are an improved generic shampoo, a 505(b)(2) scalp-delivery product, and a differentiated vehicle that reduces ethanol or surfactant irritation while preserving clobetasol delivery.

What is CLODAN and how is it used?

CLODAN is a high-potency topical corticosteroid shampoo containing clobetasol propionate at 0.05% w/w. The labeled indication is moderate-to-severe scalp psoriasis in patients 18 years and older. The product is applied once daily to dry scalp, left in place for approximately 15 minutes, and then rinsed. Treatment is limited to a short duration, generally up to four weeks, because of clobetasol's high potency and the risk of local and systemic corticosteroid adverse effects.[1]

Attribute	CLODAN profile
Active ingredient	Clobetasol propionate
Strength	0.05%
Dosage form	Medicated shampoo
Route	Topical scalp application
Main indication	Moderate-to-severe scalp psoriasis
Patient population	Adults
Application	Once daily to dry scalp, followed by rinsing
Pharmacologic class	Very-high-potency corticosteroid
Regulatory pathway for copies	ANDA, if pharmaceutical equivalence and bioequivalence requirements can be met
Alternative pathway	505(b)(2) for a materially differentiated vehicle or delivery system

CLODAN should be positioned against clobetasol solutions, gels, lotions, sprays, foams, and nonsteroidal scalp products. The shampoo format is useful where patients have dense hair, diffuse plaques, scale, or difficulty spreading an ointment across the scalp.

What excipients are used in CLODAN?

Public product labeling identifies a conventional aqueous-alcoholic shampoo vehicle. The inactive ingredients reported for clobetasol propionate shampoo products include water, ethanol, polymeric thickener, hydroxypropyl cellulose, polysorbate 20, citrate buffering components, and alkalizing agent.[1,2]

Excipient function	Representative excipient	Strategic role
Vehicle	Purified water	Main continuous phase
Volatility and wetting	Ethanol	Rapid evaporation, solubilization, scalp wetting
Rheology	Carbomer	Viscosity and suspension control
Film and texture control	Hydroxypropyl cellulose	Thickening and sensory modification
Solubilization	Polysorbate 20	Helps maintain active uniformity
Buffering	Citric acid and sodium citrate	pH control
pH adjustment	Sodium hydroxide	Final pH adjustment

The formulation challenge is balancing three competing requirements:

1. Keep clobetasol propionate solubilized or finely dispersed.
2. Allow the product to spread across dry scalp and remain in contact for the labeled dwell time.
3. Rinse cleanly without excessive residue, hair stiffness, burning, or scalp dryness.

Clobetasol propionate has low aqueous solubility. Ethanol and surfactant selection therefore affect assay uniformity, crystallization risk, preservative performance, and drug release. Carbomer and hydroxypropyl cellulose control viscosity but can also alter drug partitioning, rinse behavior, and scalp deposition.

How should an excipient strategy for CLODAN be designed?

A commercial excipient strategy should begin with the target product profile rather than direct ingredient substitution. The target should specify:

• Clobetasol assay and content uniformity.
• Physical stability during storage.
• No visible crystal formation.
• Controlled viscosity at room and elevated temperatures.
• Fast wetting of dry hair and scalp.
• Fifteen-minute scalp residence without excessive runoff.
• Clean rinse-off.
• Low stinging and low scalp irritation.
• Compatibility with high-density and chemically treated hair.
• Reproducible microbial quality.
• Manufacturing using standard liquid or semisolid equipment.

Solvent strategy

Ethanol is useful because it improves wetting and can support clobetasol solubilization. Its disadvantages include stinging, scalp dryness, flammability, odor, and possible precipitation when the product is diluted by water or exposed to temperature changes.

A lower-ethanol formulation could improve tolerability and handling. The trade-off is a higher risk of clobetasol crystallization and reduced chemical stability. Candidate approaches include:

• Propylene glycol or polyethylene glycol as cosolvents.
• Glycol blends that reduce ethanol dependence.
• Solubilizing surfactants at controlled concentrations.
• Fine-particle suspension systems rather than full solubilization.
• Polymer-assisted supersaturation control.

The preferred approach is not necessarily the lowest ethanol content. It is the lowest solvent burden that maintains physical stability and acceptable scalp delivery.

Surfactant strategy

A medicated shampoo requires enough surfactant to wet the scalp and remove scale, sebum, and vehicle residue. Excess surfactant can increase irritation, particularly when combined with ethanol and a potent corticosteroid.

Development should compare mild amphoteric and nonionic systems with conventional anionic surfactants. Cocamidopropyl betaine, glucosides, and selected nonionic surfactants may improve tolerability, but each introduces potential issues involving odor, impurities, viscosity, foam profile, and preservative compatibility.

A low-foam or controlled-foam system may be commercially preferable. Excessive foam can make the 15-minute application more difficult and may encourage patients to rinse prematurely.

Polymer and rheology strategy

Carbomer provides viscosity at low use levels and can support suspension stability. Hydroxypropyl cellulose can modify flow and sensory feel. A formulation using both polymers may provide better texture than either polymer alone, but polymer interactions can produce batch-to-batch viscosity variability.

Critical development variables include:

• Polymer grade and molecular weight.
• Neutralization level.
• Electrolyte sensitivity.
• Viscosity after active addition.
• Viscosity after accelerated aging.
• Shear recovery after filling and transport.
• Interaction with ethanol and surfactants.

A robust product should remain pourable, spreadable, and homogeneous across its shelf life. Over-thickening creates dosing variability and packaging problems. Under-thickening increases runoff and reduces scalp contact.

pH and buffering

The citrate buffer system provides a practical platform for controlling pH. The target pH must balance:

• Clobetasol chemical stability.
• Polymer viscosity.
• Scalp tolerability.
• Preservative effectiveness.
• Hair and cuticle compatibility.
• Packaging compatibility.

A narrower pH specification may improve product consistency but increase manufacturing rejection risk. The commercial formulation should use the least complex buffering system that provides reliable stability.

What formulation patents could protect an improved CLODAN product?

The active ingredient is an old corticosteroid, so new composition-of-matter protection for clobetasol propionate is unavailable. The relevant intellectual-property opportunity is formulation and delivery protection.

Potential claim categories include:

• A specific low-ethanol or ethanol-free clobetasol shampoo.
• A defined surfactant and polymer combination.
• A stable clobetasol suspension with particle-size limits.
• A composition that prevents crystal growth during storage.
• A formulation with a defined scalp deposition profile.
• A product with improved rinseability or reduced irritation.
• A multi-dose package that limits contamination.
• A manufacturing process that controls particle size or polymorphic form.
• A method of treating scalp psoriasis using a specified short-contact regimen.

Method-of-use claims may be commercially useful when they are tied to a differentiated regimen, such as reduced application frequency, shorter contact time, or treatment of a defined patient subgroup. Their enforceability depends on claim scope, evidence, labeling, and the nature of competing products.

A formulation patent is stronger when it links excipient ranges to measurable technical effects. A claim that merely lists familiar excipients at routine concentrations is more vulnerable to obviousness challenges.

When does CLODAN lose exclusivity?

CLODAN's commercial exclusivity is primarily affected by the age of clobetasol propionate, the status of the specific product approval, any Orange Book-listed patents or exclusivity, and the availability of competing clobetasol dosage forms.

Exclusivity element	Commercial assessment
Active ingredient exclusivity	Not available for the mature clobetasol molecule
New chemical entity exclusivity	Not applicable
Orphan exclusivity	Not applicable to the labeled scalp psoriasis use
Pediatric exclusivity	Must be confirmed from the current FDA listing
Orange Book patents	Product-specific review required
Generic pathway	ANDA is the expected route for pharmaceutical-equivalent shampoo
Reformulated product	May qualify for 505(b)(2) if relying on existing findings while introducing meaningful differences

The practical loss of exclusivity for a topical product does not depend only on a nominal patent expiration date. Generic applicants must also address vehicle composition, active uniformity, microbiological quality, physical stability, and comparative performance.

What is the Orange Book status of CLODAN?

The Orange Book should be reviewed for the specific CLODAN application, strength, dosage form, and sponsor. The relevant questions are:

• Whether the product remains listed as approved or discontinued.
• Whether patents are listed for the product.
• Whether any listed patent has an expiration date that remains commercially relevant.
• Whether paragraph IV certifications have been filed.
• Whether the listed product is eligible for an ANDA reference-product designation.

A discontinued brand may still be useful as a reference for formulation development, but commercial launch requires a legally usable reference product and an FDA-accepted regulatory pathway. A discontinued product does not automatically eliminate patent or regulatory issues.

Which companies are challenging CLODAN or competing with it?

The competitive field is broader than direct CLODAN copies. Relevant competitors include manufacturers of:

• Clobetasol propionate shampoo.
• Clobetasol propionate foam.
• Clobetasol propionate topical solution.
• Clobetasol propionate gel and lotion.
• Fluocinonide scalp solution.
• Betamethasone scalp products.
• Calcipotriene and corticosteroid combinations.
• Nonsteroidal psoriasis products.
• Ketoconazole and other medicated shampoos used for overlapping scalp symptoms.

Generic dermatology companies, specialty topical manufacturers, contract development organizations, and companies with spray, foam, or aerosol platforms are the most credible sources of competitive pressure.

Direct CLODAN challenges may be less important than substitution. Physicians and patients can move from a shampoo to a foam or solution without waiting for a therapeutically identical generic. A generic shampoo therefore needs a clear advantage in price, tolerability, packaging, or patient convenience.

What generic entry risks exist for CLODAN?

ANDA risk

A conventional ANDA may be commercially attractive if the reference product is available and the FDA accepts the proposed product as pharmaceutically equivalent. The main risks are:

• Difficulty demonstrating equivalent drug release from a different vehicle.
• Variability in clobetasol content across the bottle.
• Crystal formation during storage.
• Inconsistent viscosity after scale-up.
• Differences in inactive ingredients that affect local performance.
• Lack of a reliable commercial reference product.
• Patent certifications or litigation.
• Limited market size relative to development cost.

Topical products often require more than simple formulation matching. FDA may evaluate comparative attributes involving adhesion, release, and local availability depending on the dosage form and regulatory guidance.[3]

505(b)(2) risk

A 505(b)(2) strategy can support a materially improved formulation, such as:

• Reduced ethanol.
• Lower-irritation surfactant system.
• Enhanced scalp deposition.
• Controlled-release polymer network.
• Foam, spray, or film-forming delivery.
• Packaging that improves dose control.

The route can create product differentiation, but it requires clinical and comparative evidence proportionate to the formulation change. The development program must show that the new vehicle does not alter safety or efficacy in an unacceptable manner.

What manufacturing and IP barriers affect CLODAN?

The main manufacturing barriers are technical rather than chemical.

Manufacturing controls

Important process parameters include:

• Order of excipient addition.
• Polymer hydration time.
• Neutralization sequence.
• Ethanol addition temperature.
• Active premix preparation.
• Homogenization or recirculation conditions.
• Filling temperature.
• Headspace and package compatibility.
• Microbial control during bulk holding.

Clobetasol content uniformity becomes more difficult when the active is suspended rather than fully dissolved. A suspension may improve solvent tolerance but requires tight control of particle-size distribution and mixing.

Packaging

A bottle, tube, pump, or unit-dose package can change product performance. Packaging development should assess:

• Dose delivered per application.
• Product retention in the package.
• Evaporation of ethanol.
• Closure integrity.
• Chemical extractables and leachables.
• Patient ability to apply the product directly to the scalp.
• Compatibility with high-viscosity formulations.

A metered pump or applicator tip could support a differentiated 505(b)(2) product by improving dosing and reducing contact with the hands. Packaging claims alone may be weak, but packaging combined with a validated dosing benefit can create commercial value.

How does CLODAN compare with clobetasol foam and solution?

Attribute	CLODAN shampoo	Clobetasol foam	Clobetasol solution
Scalp coverage	Strong for diffuse disease	Strong for hair-bearing scalp	Strong for targeted areas
Hair cosmetic impact	Rinses off	Usually low residue	May leave alcohol or solvent residue
Application burden	Apply, wait, rinse	Apply and leave on	Apply and leave on
Contact time	Short-contact regimen	Leave-on	Leave-on
Formulation opportunity	Surfactant, polymer, solvent, rinseability	Foam structure and propellant	Solvent, drying, applicator
Main patient concern	Stinging, dryness, rinsing	Cost and dispensing	Odor, runoff, residue
Generic differentiation	Moderate	Moderate to high	Moderate

CLODAN's main advantage is short-contact treatment with a rinse-off format. Its main disadvantage is the extra application step. A new product that keeps the shampoo's scalp coverage but reduces the required contact time could be commercially differentiated.

What commercial opportunities exist for CLODAN excipient innovation?

Low-irritation generic

The most accessible opportunity is a lower-irritation generic using a milder surfactant system and optimized solvent blend. The product could target patients who discontinue alcohol-heavy or highly foaming scalp treatments.

Ethanol-reduced 505(b)(2) product

An ethanol-reduced product could address stinging, dryness, flammability, and odor. The development risk is physical stability. A successful platform would need strong crystallization control and comparative scalp-delivery data.

Premium scalp applicator

A metered applicator, narrow nozzle, or comb-style delivery system could improve product placement through dense hair. This may support higher pricing, adherence claims, and specialty-pharmacy positioning.

Shorter-contact formulation

A formulation that delivers equivalent scalp exposure in less than 15 minutes could reduce patient burden. This opportunity requires pharmacokinetic, dermatologic, or clinical evidence because the labeled contact time is part of the product's therapeutic use.

Combination product

A clobetasol shampoo combined with an anti-inflammatory, keratolytic, or antifungal active could address mixed scalp disease. Combination development faces additional compatibility, safety, labeling, and regulatory requirements. The commercial opportunity is greater if the second active addresses a common treatment barrier, such as scale or seborrheic overlap.

Global formulation platform

An ethanol-free or lower-alcohol vehicle may be easier to adapt across jurisdictions with different excipient preferences and labeling requirements. Geographic expansion should account for local requirements covering alcohol declarations, preservatives, cosmetic ingredients, and topical bioequivalence.

How strong is the CLODAN patent estate?

The underlying clobetasol molecule has little strategic patent value because it is mature. The commercially relevant estate would consist of product-specific formulation, delivery, manufacturing, or method-of-use patents.

Patent strength should be assessed against five criteria:

1. Whether the claims cover a narrow excipient combination that competitors can avoid.
2. Whether the claims include measurable stability or deposition limitations.
3. Whether the formulation produces an unexpected tolerability or delivery result.
4. Whether the patent has enforceable geographic coverage.
5. Whether the claims can be practiced by a product that receives FDA approval.

A broad patent claiming clobetasol in a shampoo is unlikely to provide durable protection. A narrower claim covering a defined polymer-solvent-surfactant system, supported by comparative data, has greater value but may still permit design-around products.

Key Takeaways

• CLODAN is a clobetasol propionate 0.05% medicated shampoo for short-term adult scalp psoriasis treatment.
• The primary development opportunity is the vehicle, not the active ingredient.
• Ethanol, surfactants, carbomer, hydroxypropyl cellulose, polysorbate 20, and citrate buffering components are central formulation variables.
• The strongest near-term product concept is a lower-irritation, stable generic shampoo.
• The strongest differentiated opportunity is a 505(b)(2) formulation with reduced ethanol, improved scalp deposition, shorter contact time, or better dosing.
• Generic risks include physical instability, crystal formation, topical equivalence, reference-product availability, and formulation patent challenges.
• A robust patent position requires technical claim limitations tied to measurable stability, delivery, or tolerability benefits.
• Competition comes from clobetasol foams and solutions as much as from direct shampoo copies.
• Packaging and applicator design can create commercial differentiation when linked to improved dose placement and adherence.

FAQs

Is CLODAN a biologic or does it face biosimilar competition?

No. CLODAN contains clobetasol propionate, a synthetic small-molecule corticosteroid. Competition comes from generic topical products, not biosimilars.

Can an ethanol-free CLODAN formulation be filed as an ANDA?

Possibly, but a material vehicle change may create questions about pharmaceutical equivalence, local delivery, and comparative performance. A 505(b)(2) pathway may be more suitable if the formulation has meaningful clinical or delivery differences.

What excipient is most important for CLODAN stability?

No single excipient controls the product. The solvent system, polymer network, surfactant concentration, pH, and active particle state must be optimized together.

Can a new CLODAN shampoo receive a new patent?

Yes, but protection would need to arise from a novel formulation, delivery system, manufacturing process, or treatment method. The mature clobetasol molecule itself cannot support new composition-of-matter exclusivity.

What is the most attractive commercial differentiation for a CLODAN competitor?

A low-irritation, cosmetically acceptable product with reliable scalp placement and simpler dosing is the clearest opportunity. A validated shorter-contact regimen would provide stronger differentiation but require a more demanding development program.

References

1. U.S. Food and Drug Administration. (n.d.). Clobetasol propionate shampoo, 0.05% prescribing information.
2. National Library of Medicine. (n.d.). DailyMed: Clobetasol propionate shampoo.
3. U.S. Food and Drug Administration. (2022). Draft guidance for industry: Topical dermatologic corticosteroids: In vivo bioequivalence.
4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.