List of Excipients in Branded Drug ALCLOMETASONE DIPROPIONATE

Generic Drugs Containing ALCLOMETASONE DIPROPIONATE

Company	Ingredient	NDC	Excipient
E Fougera & Co a division of Fougera Pharmaceuticals Inc	alclometasone dipropionate	0168-0263	CETETH-20
E Fougera & Co a division of Fougera Pharmaceuticals Inc	alclometasone dipropionate	0168-0263	CETOSTEARYL ALCOHOL
E Fougera & Co a division of Fougera Pharmaceuticals Inc	alclometasone dipropionate	0168-0263	CHLOROCRESOL
E Fougera & Co a division of Fougera Pharmaceuticals Inc	alclometasone dipropionate	0168-0263	GLYCERYL MONOSTEARATE
E Fougera & Co a division of Fougera Pharmaceuticals Inc	alclometasone dipropionate	0168-0263	PETROLATUM
E Fougera & Co a division of Fougera Pharmaceuticals Inc	alclometasone dipropionate	0168-0263	PHOSPHORIC ACID
E Fougera & Co a division of Fougera Pharmaceuticals Inc	alclometasone dipropionate	0168-0263	POLYETHYLENE GLYCOL 4500

What are the Most Frequently-Used Excipients in ALCLOMETASONE DIPROPIONATE?

# Of NDCs	Excipient
4	CETETH-20
3	CETOSTEARYL ALCOHOL
1	CETYL ALCOHOL
4	CHLOROCRESOL
4	GLYCERYL MONOSTEARATE
2	HEXYLENE GLYCOL
3	PEG-100 STEARATE

Alclometasone Dipropionate Excipient Strategy and Commercial Opportunities

Last updated: August 9, 2026

Alclometasone dipropionate is an established low- to mid-potency topical corticosteroid sold primarily as 0.05% cream and ointment. Its active-ingredient patent risk is largely historical, so commercial value is concentrated in vehicle performance, pediatric tolerability, preservative systems, packaging, manufacturing efficiency, and differentiated topical delivery. The strongest opportunities are generic or reformulated products that improve cosmetic acceptability, reduce irritation, support sensitive-skin use, and address adherence problems without materially changing corticosteroid exposure.

What is alclometasone dipropionate used for?

Alclometasone dipropionate is a topical corticosteroid indicated for corticosteroid-responsive dermatoses, including atopic dermatitis and contact dermatitis. The labeled dosage forms are cream and ointment at a concentration of 0.05% [1].

The product has commercial relevance in populations where clinicians want a topical corticosteroid with lower potency than many class I or class II agents. Labeling permits use in adults and pediatric patients, including children as young as 1 year, subject to dosing and duration limitations [1].

Attribute	Alclometasone dipropionate
Active ingredient	Alclometasone dipropionate
Dosage form	Topical cream and ointment
Strength	0.05%
Therapeutic class	Topical corticosteroid
Typical positioning	Low- to mid-potency treatment for inflammatory dermatoses
Pediatric use	Labeled for patients 1 year and older
FDA pathway for generics	Abbreviated New Drug Application
Biosimilar exposure	None
Primary differentiation opportunity	Vehicle, tolerability, packaging and adherence

Topical corticosteroids have no conventional biosimilar pathway. A competitor generally enters through an ANDA for a pharmaceutically equivalent product or through a reformulation strategy that may require a different FDA pathway.

What excipients are used in alclometasone dipropionate products?

The principal excipient strategy is vehicle selection. Creams generally target spreadability, lower greasiness and acceptable use on inflamed or intertriginous skin. Ointments prioritize occlusion, emollience and treatment of dry, fissured lesions.

Commercial products and generic labels can use different inactive-ingredient systems while retaining the same active ingredient, strength and dosage form. FDA-approved inactive ingredients must be appropriate for the route and dosage form, and the finished product must meet quality and performance requirements [2].

Cream excipient functions

A conventional alclometasone cream may use the following excipient classes:

Excipient class	Function	Commercial relevance
Purified water	Continuous phase in an oil-in-water emulsion	Supports light texture and washability
Propylene glycol or another humectant	Solvent, humectant and penetration-supporting excipient	Can improve hydration but may sting compromised skin
Fatty alcohols	Consistency, emulsion stabilization and skin feel	Affect viscosity and rub-in
Glyceryl stearate and PEG stearates	Emulsification	Control physical stability and texture
Mineral oil or similar emollient	Oil phase and skin conditioning	Increases occlusivity and glide
Polysorbates or sorbitan esters	Emulsion stabilization	Influence preservative compatibility and sensory profile
Preservatives	Microbial protection	Major differentiator for sensitive-skin positioning
Buffering agents	pH control	Can affect stability, irritation and preservative performance
Thickening polymers	Rheology and suspension stability	Enable cream consistency and phase control

The formulation should be evaluated as a system. A change in propylene glycol, surfactant, preservative or polymer can alter drug release, skin partitioning, viscosity, phase stability and local tolerability. For a topical corticosteroid, sameness of nominal strength does not guarantee sameness of clinical feel or patient adherence.

Ointment excipient functions

Ointments typically rely on hydrophobic excipients such as petrolatum and mineral oil. Their commercial advantages are strong occlusion, reduced water loss and suitability for dry lesions. Their disadvantages include greasiness, poor cosmetic acceptance and lower acceptability for daytime or facial use.

A petrolatum-based alclometasone ointment can be attractive for severe xerosis and fissuring. A less occlusive ointment or emollient-rich semi-solid may have stronger consumer acceptance but can create more complex equivalence and manufacturing questions.

What formulation strategies could differentiate alclometasone dipropionate?

The most practical strategies are improvements to existing cream and ointment vehicles rather than development of a novel corticosteroid product.

Preservative-reduced or preservative-free cream

Preservatives can contribute to irritation or allergic contact dermatitis in patients with compromised skin. A preservative-free or low-preservative cream could target pediatric dermatology, facial dermatitis and patients with known preservative sensitivity.

The primary technical challenge is microbial control. A preservative-free product may require:

• A low-water or anhydrous system
• Single-use packaging
• An airless pump
• A controlled-dose tube
• More stringent manufacturing controls
• Container-closure validation

A preservative-free claim would need appropriate stability, microbial limits and packaging data. It would also need to avoid implying superior clinical safety unless supported by evidence.

Low-sting pediatric cream

Alclometasone is labeled for pediatric use, creating a clear vehicle opportunity. Pediatric users may have higher sensitivity to stinging, fragrance, residual tack and difficult application.

A pediatric-focused vehicle could remove fragrance, reduce volatile or potentially irritating components, use a moderate pH, improve spreadability and reduce residue after application. The product should avoid unnecessary essential oils, botanical extracts and sensitizing fragrance components.

Commercial positioning could focus on:

• Sensitive skin
• Atopic dermatitis
• Face and flexural areas where clinically appropriate
• Easier application
• Better acceptance by caregivers and children

The product cannot claim reduced systemic corticosteroid risk solely from excipient selection. Systemic absorption remains dependent on potency, treated area, duration, skin integrity, occlusion and patient age [1].

Barrier-support cream

A cream containing barrier-supporting lipids, humectants or emollients could compete with standard generic vehicles. Candidate excipient categories include ceramide-like lipids, glycerol, fatty alcohols, triglycerides and non-irritating occlusives.

The commercial benefit is a combined anti-inflammatory and skin-conditioning proposition. The regulatory risk is claim expansion. If the product makes therapeutic claims beyond the approved corticosteroid indication, the sponsor may face additional clinical and regulatory requirements.

Fast-absorbing cream

Many patients avoid ointments because of greasiness. A faster-rubbing cream with lower residue could improve adherence for daytime use, occupational settings and visible areas.

The formulation target is a balance among:

• Rapid rub-in
• Adequate skin hydration
• Consistent drug release
• Low tack
• No phase separation
• Acceptable preservative performance
• Stable assay and degradation profile

A low-residue vehicle may improve commercial performance but can reduce occlusion and alter drug delivery. Comparative in vitro release testing, rheology, particle or droplet characterization and clinical endpoint data may be needed depending on the regulatory pathway.

Foam, spray or gel systems

Foams, sprays and gels could improve application to hair-bearing areas, large body surfaces or difficult-to-reach locations. These products would not be simple line extensions from a cream or ointment.

They may require a new drug application, a 505(b)(2) pathway or another regulatory strategy, depending on the formulation, delivery system and available reference-product data. Aerosol systems add requirements involving propellants, flammability, pressure vessels, valve performance and dose uniformity.

The opportunity is commercially meaningful but technically less attractive than a differentiated cream because development costs, device requirements and regulatory burden are higher.

What patent opportunities exist for alclometasone dipropionate formulations?

The original active-ingredient protection for alclometasone dipropionate is no longer the central barrier to entry. The relevant intellectual-property opportunities are formulation, delivery, packaging and manufacturing patents.

Formulation patents

Potential claim areas include:

• Specific emulsion compositions
• Preservative-free aqueous systems
• Anhydrous ointments
• Low-sting vehicles
• Defined pH ranges
• Specific lipid or humectant combinations
• Particle-size distributions
• Enhanced drug-release profiles
• Reduced crystallization during storage
• Improved physical stability
• Reduced degradation or discoloration

A formulation patent is stronger when it connects composition to a measurable technical effect. Examples include improved stability, reduced phase separation, controlled release, lower irritation scores or a defined pharmacokinetic advantage.

A broad claim covering any cream containing alclometasone dipropionate would face substantial validity and obviousness risk because topical corticosteroid creams are an established field. Narrower claims tied to specific excipient ratios, processing conditions and performance data are more defensible.

Method-of-use patents

Potential method claims could address treatment of specific inflammatory dermatoses, treatment duration, body-site limitations or use in defined patient populations. These claims face prior-art and obviousness challenges because alclometasone’s dermatologic uses are already established.

Method-of-use patents may still have value when they rely on:

• A new dosing schedule
• A defined short-course regimen
• A specific pediatric population
• A particular anatomical site
• A documented tolerability or adherence advantage
• A combination with a non-corticosteroid barrier therapy

The commercial value depends on whether the use can be carved out of generic labeling and enforced without creating substantial prescription substitution pressure.

Packaging and device patents

Packaging claims may protect:

• Airless pumps
• Unit-dose sachets
• Metered-dose topical applicators
• Child-resistant tubes
• Low-residue dispensing systems
• Packaging that limits oxygen or microbial ingress
• Applicators for scalp or hair-bearing skin

Packaging patents are often easier to design around than formulation patents. Their commercial value is highest when the package solves a clear problem, such as contamination, dosing inconsistency or application to sensitive areas.

What is the FDA regulatory status of alclometasone dipropionate?

Alclometasone dipropionate is an FDA-regulated prescription topical corticosteroid. The reference product Aclovate was marketed as cream and ointment at 0.05%; current commercial availability depends on the product and manufacturer [1].

Generic products generally require an ANDA demonstrating pharmaceutical equivalence and bioequivalence or other applicable product-performance evidence. Topical products may require comparative characterization, in vitro release testing, dermatopharmacokinetic testing or clinical endpoint studies, depending on FDA guidance and product-specific requirements [2, 3].

The sponsor should distinguish three regulatory strategies:

Strategy	Typical pathway	Main advantage	Main barrier
Generic cream or ointment	ANDA	Lower development cost	Price competition and equivalence requirements
Differentiated vehicle	ANDA if requirements are met; otherwise alternative pathway	Commercial differentiation	Formulation and equivalence complexity
New dosage form or delivery system	NDA or 505(b)(2), depending on facts	Potential exclusivity and premium pricing	Higher clinical and regulatory cost

What is the Orange Book and patent status for alclometasone dipropionate?

The Orange Book is the primary FDA source for approved drug products, therapeutic equivalence evaluations and listed patents or exclusivity information [4]. For an established topical corticosteroid such as alclometasone dipropionate, the commercial entry analysis should focus on whether any listed patents or exclusivity periods remain relevant to a specific reference product.

The key findings for business planning are:

• Active-ingredient exclusivity is historical rather than a current entry barrier.
• No biosimilar pathway applies.
• Generic applicants may face product-specific patent certifications if relevant patents are listed.
• Formulation and device patents can create new barriers even when the active ingredient is mature.
• Patent term adjustment, pediatric exclusivity and later-listed patents must be reviewed at the product level.
• A discontinued or limited-availability reference product can create reference-product sourcing and market-access issues.

A Paragraph IV challenge would be relevant only if a listed patent remained in force and materially covered the reference product. The value of such a challenge would depend on remaining patent term, market size, probability of invalidity or non-infringement, and the availability of non-infringing formulations.

When does alclometasone dipropionate lose exclusivity?

The active ingredient has already passed its principal exclusivity period. Current commercial protection, if any, depends on product-specific patents, formulation claims, regulatory exclusivity and trademarks rather than basic molecule protection.

Protection type	Current commercial significance
Original compound patent	Historical
Original FDA exclusivity	Expired
Formulation patents	Potentially relevant only if valid and unexpired
Method-of-use patents	Potentially relevant for narrow labeled uses
Device patents	Relevant to differentiated delivery systems
Trademark protection	Brand-specific; does not prevent generic substitution
Pediatric exclusivity	Historical unless tied to a later qualifying product

A generic launch scenario is therefore most likely to involve standard cream or ointment competition. A premium launch would require a differentiated vehicle, delivery system, packaging platform or evidence-backed clinical advantage.

Which companies compete in the alclometasone dipropionate market?

Competition is primarily among generic topical manufacturers and distributors. The relevant competitive dimensions are:

• FDA-approved product availability
• Cream versus ointment supply
• Wholesale acquisition cost
• Pharmacy reimbursement
• Tube sizes
• Preservative profile
• Manufacturing reliability
• Formulary and wholesaler access
• Therapeutic substitution with other low- or mid-potency corticosteroids

Alclometasone also competes indirectly with hydrocortisone, desonide, fluocinolone acetonide, triamcinolone acetonide and other topical corticosteroids. Desonide can be a particularly relevant comparator for lower-potency use, while triamcinolone products compete on price, familiarity and dosage-form breadth.

How does alclometasone compare with competing topical corticosteroids?

Product	Common positioning	Commercial comparison
Hydrocortisone	Lower potency, broad OTC and prescription presence	Strong price competition and wide consumer familiarity
Desonide	Low-potency prescription corticosteroid	Competes in pediatric and sensitive-site treatment
Alclometasone dipropionate	Low- to mid-potency prescription corticosteroid	Opportunity for differentiated pediatric and sensitive-skin vehicles
Triamcinolone acetonide	Broad range of topical formulations and strengths	Larger generic footprint and strong physician familiarity
Fluocinolone acetonide	Low- to mid-potency topical corticosteroid	Competes in dermatitis and specialty formulations

Alclometasone’s strongest commercial position is not molecule novelty. It is a differentiated delivery proposition for patients who need prescription corticosteroid activity but reject greasy, stinging or cosmetically unacceptable vehicles.

What manufacturing and intellectual-property barriers affect entry?

The main manufacturing barriers are product performance and consistency rather than active-ingredient synthesis.

Critical controls include:

• Uniform drug distribution
• Control of emulsion droplet size
• Viscosity and rheology
• Microbial quality
• Preservative effectiveness
• Active-ingredient assay
• Degradation products
• Phase stability
• Tube or pump compatibility
• Fill-weight accuracy
• Scale-up reproducibility

Alclometasone dipropionate is a potent active at a low concentration. Small blending or sampling errors can create significant content-uniformity problems. Manufacturing processes should use validated geometric dilution, controlled shear and appropriate in-process sampling.

The strongest manufacturing IP may cover a reproducible process that limits crystallization, improves content uniformity or maintains release performance after scale-up. Process patents are more commercially useful when they are difficult to design around and produce a measurable cost or quality advantage.

What commercial opportunities exist for alclometasone dipropionate?

The most attractive opportunities rank as follows:

1. Generic cream with a low-sting, fragrance-free vehicle. This has the clearest balance of market need, technical feasibility and regulatory practicality.
2. Preservative-reduced or preservative-free product. This supports sensitive-skin and pediatric positioning but requires rigorous microbial-control design.
3. Barrier-supportive cream. This may improve adherence and create a differentiated brand, subject to claim discipline.
4. Improved ointment with lower residue. This addresses the main weakness of conventional ointments.
5. Unit-dose or airless packaging. This can support hygiene, dosing consistency and premium positioning.
6. Foam, gel or spray. This offers higher differentiation but carries the greatest development and regulatory burden.
7. International formulation expansion. Geographic opportunities depend on local registration status, reference-product availability, excipient rules and local patent searches.

Revenue exposure is likely to be constrained by generic substitution and the availability of competing corticosteroids. A premium strategy requires evidence that prescribers, payers or patients will pay for the vehicle or delivery advantage. A low-cost ANDA strategy has lower clinical risk but faces rapid price erosion.

Key Takeaways

• Alclometasone dipropionate is a mature topical corticosteroid with limited molecule-level exclusivity value.
• The strongest commercial opportunity is a differentiated 0.05% cream, not a new active-ingredient program.
• Excipient selection should focus on low sting, fragrance-free composition, spreadability, barrier support and acceptable residue.
• Preservative-free and pediatric-oriented products can create meaningful differentiation if microbial control is robust.
• Formulation, packaging, manufacturing and narrow method-of-use patents are the principal IP opportunities.
• Cream and ointment products are more practical than foam, spray or gel systems.
• Generic entry risk is high for conventional products because the active ingredient and dosage forms are established.
• No biosimilar strategy applies.
• A Paragraph IV strategy has value only if a relevant, unexpired listed patent remains tied to the reference product.
• Commercial success depends on payer acceptance, pharmacy substitution, supply reliability and demonstrable vehicle advantages.

FAQs About Alclometasone Dipropionate Excipient and Patent Strategy

Can propylene glycol be removed from alclometasone dipropionate cream?

Yes, but removal can change solubility, drug release, viscosity, preservation and skin feel. A replacement solvent or humectant system must support stability and equivalent product performance.

Is a preservative-free alclometasone cream commercially viable?

Yes. The opportunity is strongest for pediatric, facial and sensitive-skin use. The formulation must use packaging and manufacturing controls that maintain microbiological quality throughout the labeled use period.

Can alclometasone dipropionate be developed as an over-the-counter product?

A switch from prescription to OTC status would require FDA review of the active ingredient, indication, labeling, consumer comprehension and safe self-selection. Existing prescription approval does not establish OTC eligibility.

What is the best package for a premium alclometasone product?

An airless pump or controlled-dose tube can support hygiene, low contamination risk and dosing consistency. The preferred package depends on viscosity, preservative system, fill size and intended body site.

Can a new alclometasone vehicle receive regulatory exclusivity?

Potentially, if the product qualifies under an applicable NDA or 505(b)(2) pathway and meets the statutory requirements for exclusivity. An ordinary ANDA generic generally does not receive new innovation exclusivity merely because its excipients differ.

References

1. U.S. National Library of Medicine. (n.d.). Alclometasone dipropionate cream and ointment prescribing information. DailyMed.
2. U.S. Food and Drug Administration. (2019). Inactive ingredient database guidance and database. FDA.
3. U.S. Food and Drug Administration. (2022). Topical dermatologic corticosteroids: Product-specific guidance for industry. FDA.
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.