List of Excipients in Branded Drug CLODERM

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Promius Pharma LLC	CLODERM	clocortolone pivalate	67857-804	CARBOMER HOMOPOLYMER TYPE B
Promius Pharma LLC	CLODERM	clocortolone pivalate	67857-804	EDETATE DISODIUM
Promius Pharma LLC	CLODERM	clocortolone pivalate	67857-804	METHYLPARABEN
Promius Pharma LLC	CLODERM	clocortolone pivalate	67857-804	MINERAL OIL

CLODERM Excipient Strategy and Commercial Opportunities for Clocortolone Pivalate Cream

Last updated: August 24, 2026

Cloderm is a prescription topical corticosteroid containing 0.1% clocortolone pivalate. Its commercial opportunity is primarily formulation-driven: generic substitution, differentiated semisolid delivery, preservative and irritation reduction, larger-volume packaging, and potential lifecycle products. The key technical challenge is matching the reference cream’s critical quality attributes while preserving clocortolone pivalate solubility, particle distribution, release, skin permeation, physical stability, and tolerability.

What is Cloderm and how is it regulated?

Cloderm Cream contains clocortolone pivalate, a fluorinated topical corticosteroid indicated for corticosteroid-responsive dermatoses. The product is a prescription drug regulated through an FDA new drug application and is administered as a topical cream rather than an oral or injectable product.[1]

The formulation contains micronized clocortolone pivalate and a conventional oil-in-water cream vehicle. Public product labeling identifies the inactive ingredients as including:

Excipient	Likely formulation role
Cetostearyl alcohol	Emulsion consistency, viscosity, emolliency
Cetyl alcohol	Thickening, emulsion stabilization, skin feel
Glyceryl stearate	Emulsifier and emollient
Isopropyl palmitate	Emollient and oil-phase solvent
Methylparaben	Preservative
Propylene glycol	Humectant, solvent, penetration-supporting excipient
Purified water	Continuous aqueous phase
Sodium citrate	Buffering and pH control
Stearic acid	Consistency agent and co-emulsifier
Sorbitol	Humectant and water-activity modifier

The active concentration is 0.1% w/w. For a 30-gram tube, this represents approximately 30 mg of clocortolone pivalate before accounting for manufacturing overage.

What FDA approval pathway applies to Cloderm generics?

A generic clocortolone pivalate cream would generally be submitted through an abbreviated new drug application. The applicant must establish pharmaceutical equivalence and demonstrate bioequivalence under the applicable FDA framework for topical semisolid products.[2]

For a conventional topical cream, the central development issues are:

• Same active ingredient and strength
• Same dosage form and route of administration
• Comparable inactive-ingredient functionality
• Comparable physicochemical properties
• Comparable drug release
• Comparable skin permeation or local bioavailability
• Acceptable microbial quality and preservative performance
• Satisfactory tube compatibility and stability

The FDA’s topical product guidance emphasizes product quality attributes such as appearance, pH, viscosity, globule size, particle size, polymorphic form, water activity, rheology, and in vitro drug release.[2]

What excipient strategy does Cloderm use?

Cloderm uses a conventional, water-continuous cream designed to balance corticosteroid delivery with cosmetic acceptability. Its excipient strategy has four functional layers.

How do the oil-phase excipients support drug delivery?

Isopropyl palmitate, stearic acid, glyceryl stearate, cetyl alcohol, and cetostearyl alcohol create the cream’s internal oil phase and structural network. These materials influence:

• Clocortolone pivalate solubilization and partitioning
• Droplet size and emulsion stability
• Spreadability
• Residual skin feel
• Drug release from the vehicle
• Occlusivity and hydration of the stratum corneum

Clocortolone pivalate is a lipophilic corticosteroid. The oil phase therefore has a direct impact on whether the active remains dissolved, partially dissolved, or suspended. Changes in fatty alcohol concentration can alter viscosity and drug release even when the nominal excipient list remains similar.

What role does propylene glycol play?

Propylene glycol is a multifunctional excipient. In Cloderm, it can operate as:

1. A cosolvent for the active ingredient
2. A humectant
3. A skin penetration-supporting excipient
4. A processing aid for aqueous and oil-phase distribution

Propylene glycol concentration is a major formulation variable. Increasing it may improve drug solubilization or release, but excessive levels can increase irritation, burning, or stinging in compromised skin. A generic developer should treat propylene glycol as a critical material attribute rather than a routine vehicle component.

Why are sorbitol and the citrate system commercially relevant?

Sorbitol contributes water binding and may improve hydration and sensory properties. Sodium citrate provides buffering capacity and helps control pH during storage. The pH of a topical corticosteroid cream affects preservative performance, emulsion stability, active stability, and patient tolerability.

A reformulator should avoid changing the buffer system without measuring:

• Initial and aged pH
• Preservative efficacy
• Clocortolone pivalate degradation
• Rheology over shelf life
• Packaging extractables and leachables
• Drug release and permeation

What is the role of methylparaben?

Methylparaben provides antimicrobial preservation in the aqueous cream system. It also creates a potential differentiation point. Some patients and prescribers prefer formulations with fewer preservatives because of irritation, allergy, or chronic-use concerns.

A preservative-free alternative would require a redesigned manufacturing and packaging system. Options could include:

• Airless pump packaging
• Unit-dose packaging
• Reduced-water or anhydrous cream
• Improved water-activity control
• Alternative preservation systems
• Sterile or low-bioburden manufacturing, where justified

A preservative-free claim would require product-specific microbiological and stability evidence. It cannot be inferred solely from omission of methylparaben.

What formulation patents could protect a Cloderm commercial opportunity?

The most defensible intellectual-property opportunities are likely to arise from formulation architecture rather than from the basic active ingredient. Potential claim areas include:

• Specific clocortolone pivalate particle-size distributions
• Defined crystalline or polymorphic forms
• Particular propylene glycol concentrations
• Preservative-free cream systems
• Low-irritation excipient combinations
• Controlled-release or enhanced-release semisolids
• Foam, gel, lotion, spray, or emulsion dosage forms
• Packaging systems that improve stability or reduce contamination
• Manufacturing processes that produce a defined microstructure
• Topical treatment methods using a particular dosing schedule

A formulation patent must connect the excipient combination to a measurable technical effect. Broad claims covering “clocortolone pivalate in a cream” would face a substantial prior-art challenge because topical corticosteroid creams are well established.

What manufacturing and IP barriers affect generic entry?

The principal barriers are technical and evidentiary:

Barrier	Commercial effect
Micronized active distribution	Can affect uniformity, release, and bioequivalence
Active solubility in the vehicle	Changes can alter thermodynamic activity and skin delivery
Emulsion microstructure	Affects stability, rheology, and release
Preservative performance	Requires challenge testing and aged-product assessment
Scale-up shear and temperature	Can change droplet size and cream texture
Tube or pump interaction	Can affect assay, impurities, and dispensing
In vitro release variability	May delay ANDA development
Local tolerability	Can reduce substitution acceptance
Comparative clinical or PK requirements	Can increase development cost and timing

A developer that copies the excipient list but misses the reference product’s microstructure can fail comparative performance testing. Q3 characterization is therefore central to the development strategy.

How strong is the patent estate for Cloderm?

What patents protect clocortolone pivalate cream?

The basic active ingredient and original product technology are mature. The commercial value of a current Cloderm patent estate would therefore depend on later-issued formulation, method-of-use, manufacturing, or delivery patents rather than on the original molecule alone.

The FDA product label establishes the approved composition and indication but does not by itself provide a complete patent analysis.[1] Patent status must be assessed across:

• FDA Orange Book listings
• USPTO Patent Center
• Published patent applications
• Patent assignments
• Court dockets
• Paragraph IV notices
• Any approved supplements or new dosage forms

No current patent number, litigation docket, or settlement term should be treated as controlling without verification against those records. For a conventional 0.1% clocortolone pivalate cream, the risk profile is more likely to center on formulation execution and market access than on a broad, enforceable composition-of-matter patent.

When does Cloderm lose exclusivity?

The original product has been commercially available for decades, and the active ingredient is not a recently launched molecule. The key exclusivity question is therefore not expected to be basic chemical exclusivity. It is whether any currently listed patent, regulatory exclusivity period, or formulation-specific right delays an ANDA approval or launch.

For business planning, the relevant scenarios are:

Scenario	Likely consequence
No blocking patent or exclusivity	Generic approval and launch can proceed after technical and regulatory readiness
Listed formulation patent	Paragraph IV or expiration-based strategy may apply
Method-of-use patent	Label carve-out or litigation risk may arise
Unlisted patent or trade-secret process	May not block approval but can create manufacturing differentiation
Weak reference-product characterization	Development timelines and bioequivalence risk increase

What are the best excipient-driven commercial opportunities?

Is a direct generic cream the largest opportunity?

A direct generic cream is the clearest opportunity because it targets the established product, uses familiar excipients, and can compete on price, distribution, and payer coverage. The commercial risk is margin compression after multiple ANDA approvals.

A direct generic should prioritize:

• Robust Q1/Q2 formulation matching
• Q3 microstructure characterization
• Competitive tube filling and yield
• Low complaint rates
• Stable preservative performance
• Broad pharmacy and wholesaler access

The product should avoid unnecessary excipient changes that create tolerability or bioequivalence risk.

Can a preservative-free Cloderm formulation command a premium?

A preservative-free product could target patients with sensitive, atopic, or repeatedly treated skin. The opportunity is strongest if the product can demonstrate a clear tolerability or convenience advantage.

Potential dosage forms include:

• Preservative-free cream in an airless pump
• Unit-dose cream
• Anhydrous ointment or balm
• Low-water emulsion
• Metered-dose topical dispenser

The commercial tradeoff is higher packaging cost and more demanding microbial controls. A preservative-free product also risks losing the sensory profile and release behavior of the reference cream.

Is a foam or lotion formulation commercially attractive?

A foam, lotion, or spray could improve application to hair-bearing areas, large surface areas, or warmer climates. These forms may also support differentiated pricing if they improve spreadability, drying time, or patient adherence.

The main development risks are:

• Dose uniformity
• Propellant or solvent tolerability
• Container compatibility
• Flammability controls for aerosol systems
• New product-specific bioequivalence expectations
• Greater manufacturing complexity

A foam product would likely compete through convenience rather than through direct substitution alone.

Can an emollient-rich or barrier-supporting version compete?

A barrier-supporting cream could combine clocortolone pivalate with a higher-emollience vehicle, ceramide system, or reduced-irritation excipient platform. Such a product could target patients with dermatitis and dry, compromised skin.

The formulation must avoid changing corticosteroid delivery in a way that increases local adverse effects. Claims should remain within the supported labeling framework unless the product receives new regulatory approval.

What is the Orange Book status of Cloderm?

Cloderm is an FDA-approved prescription drug product, and the relevant FDA records are the NDA, product label, and Orange Book listing.[1,3] Orange Book analysis should distinguish between:

• Active ingredient listing
• Approved dosage form and strength
• Reference listed drug status
• Patent listings
• Regulatory exclusivity
• Therapeutic-equivalence codes for approved generics

For a topical cream, the Orange Book listing is important because it identifies the reference product for ANDA purposes. It does not establish that every formulation or delivery innovation is blocked by patent rights.

Which companies are challenging Cloderm?

Potential challengers would include manufacturers developing ANDAs for clocortolone pivalate cream 0.1% and companies developing alternative topical corticosteroid products. Publicly confirmed challenger identity, Paragraph IV notices, and litigation status must be tied to FDA or court records.

The competitive set includes:

• Direct generic cream manufacturers
• Specialty dermatology companies
• Branded topical corticosteroid companies
• Compounding pharmacies
• Developers of foam, lotion, spray, and ointment alternatives
• Manufacturers offering other medium- or high-potency corticosteroids

The most relevant competitive products are not necessarily pharmacologically identical. Prescriber choice is influenced by potency, vehicle, body-site suitability, formulary status, tube size, patient preference, and generic availability.

What revenue exposure does Cloderm create?

Public FDA labeling does not establish product revenue. Revenue exposure should be modeled through prescription volume, net price, payer mix, generic penetration, and channel concentration.

A practical scenario model is:

Market outcome	Branded revenue impact	Generic opportunity
No approved generic	Highest branded price retention	Limited to authorized or branded competition
One generic entrant	Moderate price pressure	Attractive first-entry economics
Several generic entrants	Significant price erosion	Volume-based, low-margin business
Differentiated reformulation	Potential premium retention	Higher development and marketing cost
Specialty delivery product	New segment revenue	Requires new clinical and regulatory investment

The strongest commercial thesis is usually a two-product strategy: a low-cost direct generic for volume and a differentiated vehicle for margin protection.

What generic launch risks exist for Cloderm?

Generic launch risk is concentrated in five areas:

1. Bioequivalence failure. Matching assay and appearance is insufficient if drug release or skin permeation differs.
2. Stability failure. Cream rheology, pH, preservative content, and active degradation can change during storage.
3. Scale-up variability. Homogenization and cooling conditions can alter microstructure.
4. Packaging failure. Tube materials, pumps, and liners can affect potency and impurity profiles.
5. Market congestion. Multiple entrants can quickly reduce price and pharmacy access.

A developer should use staged release criteria for particle size, viscosity, yield stress, globule size, pH, water activity, microbial limits, and in vitro release.

How does Cloderm compare with alternative topical corticosteroid products?

Attribute	Cloderm cream	Ointment	Lotion or solution	Foam
Active delivery	Clocortolone pivalate 0.1%	Depends on active	Depends on active	Depends on active
Occlusivity	Moderate	High	Low to moderate	Low after drying
Cosmetic feel	Cream-like	Greasy	Light	Light
Hair-bearing areas	Less convenient	Poor convenience	Better	Often strong
Dry or fissured skin	Moderate suitability	Strong suitability	Variable	Variable
Manufacturing complexity	Moderate	Lower to moderate	Moderate	Higher
Differentiation potential	Generic and vehicle-based	High emollience	Convenience	Convenience and adherence

Cloderm’s opportunity is strongest where a cream vehicle is preferred but patients need a corticosteroid with a differentiated sensory profile, reliable delivery, or improved tolerability.

Key Takeaways

• Cloderm is a 0.1% clocortolone pivalate prescription cream with a conventional emulsion-based excipient system.
• Propylene glycol, fatty alcohols, glyceryl stearate, isopropyl palmitate, sorbitol, citrate buffer, and methylparaben are central to formulation performance.
• The main generic challenge is Q3 equivalence, not simple ingredient matching.
• A direct generic is the lowest-risk commercial opportunity but is vulnerable to price erosion.
• Preservative-free, airless-pump, foam, lotion, and barrier-supporting formulations offer higher differentiation.
• Current patent and Paragraph IV conclusions require verified FDA, USPTO, and court records.
• The most durable commercial strategy combines a direct generic with a differentiated topical delivery platform.

FAQs

Can clocortolone pivalate cream be reformulated without propylene glycol?

Yes, but removing propylene glycol can change solubility, release, skin permeation, viscosity, and tolerability. The reformulation would require comparative performance and stability work.

Is Cloderm suitable for a preservative-free product line?

Potentially. An airless pump, unit-dose system, anhydrous vehicle, or reduced-water formulation could support a preservative-free strategy, subject to microbial and stability validation.

What excipient creates the greatest bioequivalence risk in a Cloderm generic?

Propylene glycol is a major risk because it can influence both active solubilization and dermal delivery. The oil-phase structure and particle-size distribution are also critical.

Could a clocortolone pivalate foam receive premium pricing?

Yes, if the foam improves application, drying time, adherence, or use on hair-bearing areas. Premium pricing would depend on regulatory approval, payer positioning, and demonstrated patient or prescriber value.

Is biosimilar competition relevant to Cloderm?

No. Cloderm contains a chemically synthesized corticosteroid, not a biologic. Competition would arise through ANDAs, branded reformulations, alternative topical corticosteroids, and potentially authorized generic products.

References

1. U.S. Food and Drug Administration. (n.d.). Cloderm Cream 0.1%: Prescribing information and product labeling. DailyMed.
2. U.S. Food and Drug Administration. (2022). Draft guidance for industry: In vitro release test studies for topical drug products submitted in ANDAs.
3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. Orange Book.
4. U.S. Food and Drug Administration. (2016). Q3 characterization of topical drug products: Guidance for industry.
5. United States Pharmacopeia. (2024). General chapters on semisolid drug products, topical preparations, and antimicrobial effectiveness testing. USP-NF.