Clocortolone pivalate - Generic Drug Details

What are the generic sources for clocortolone pivalate and what is the scope of freedom to operate?

Clocortolone pivalate is the generic ingredient in two branded drugs marketed by Taro and Legacy Pharma, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for clocortolone pivalate. One supplier is listed for this compound.

Summary for clocortolone pivalate

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	2
Patent Applications:	6,276
Drug Prices:	Drug price trends for clocortolone pivalate
What excipients (inactive ingredients) are in clocortolone pivalate?	clocortolone pivalate excipients list
DailyMed Link:	clocortolone pivalate at DailyMed

See drug prices for clocortolone pivalate

Recent Clinical Trials for clocortolone pivalate

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

Sponsor	Phase
WAYCro	Phase 1
Taro Pharmaceuticals USA	Phase 1
Promius Pharma, LLC	Phase 4

See all clocortolone pivalate clinical trials

Pharmacology for clocortolone pivalate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for clocortolone pivalate

D07AB	Corticosteroids, moderately potent (group II)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

US Patents and Regulatory Information for clocortolone pivalate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Legacy Pharma	CLODERM	clocortolone pivalate	CREAM;TOPICAL	017765-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Taro	CLOCORTOLONE PIVALATE	clocortolone pivalate	CREAM;TOPICAL	206370-001	Apr 21, 2020	AB	RX	No	No

Market Dynamics and Financial Trajectory for Clocortolone Pivalate

Last updated: February 21, 2026

Is Clocortolone Pivalate a Recognized Therapeutic Agent?

Clocortolone pivalate is a topical corticosteroid primarily used in dermatology for conditions like eczema, dermatitis, and psoriasis. It is marketed in certain countries, particularly in Europe, under specific brand names. Its authorization and regulatory status vary geographically, influencing market accessibility.

What is the Regulatory Status and Market Availability?

• Europe: Approved in countries such as Italy, Spain, and Germany. Marketed under brand names like Clovate or Clocortolone.
• Asia: Available in select markets, with regulatory approval processes similar to Europe.
• United States: Not approved by the Food and Drug Administration (FDA); limited or no market presence.

How Does the Market Penetration Look?

Limited compared to other topical corticosteroids, such as hydrocortisone or triamcinolone. The niche use is primarily in dermatological settings where options are set by regional approvals.

Market Size (Estimated)

Region	Estimated Market Size (USD, 2022)	Growth Rate (CAGR, 2022–2027)	Key Factors
Europe	$50 million	4%	Established formularies, regional approvals
Asia-Pacific	$20 million	5%	Growing dermatology demand, expanding approvals
Rest of World	$5 million	3%	Limited distribution, regulatory barriers

Total global market estimate (2022): $75 million, with projected growth driven by increasing prevalence of skin conditions and expanding approvals.

What are the Factors Influencing Market Dynamics?

Patents and Market Exclusivity

Clocortolone pivalate's patent landscape is limited. Most formulations are off-patent or have expired, leading to generic competition. This weakens profit margins and influences market entry dynamics.

Competitive Landscape

• Major competitors: Hydrocortisone, betamethasone, triamcinolone.
• Market saturation: Moderate, with many generics available.
• Pricing: Competitive pricing pressures have constrained revenue potential.

Regional Policies and Prescribing Trends

• European Regulations: Strict approval procedures restrict market entry to regionally authorized drugs.
• Consumer Preferences: Preference for safer, lower-potency corticosteroids in certain markets influences sales.
• Physician Adoption: Limited awareness outside dermatology specialists affects prescribing behavior.

R&D and Pipeline Outlook

No significant R&D investments for clocortolone pivalate are publicly reported, indicating limited future pipeline development. The focus has shifted to alternative treatments and newer corticosteroids.

How Do Financials Shape the Outlook?

Revenue Projections

• Current Revenue (2022): Approximate global sales at $75 million.
• Forecast (2027): Expected to reach $90 million, assuming steady growth driven by regional approvals and increased dermatology cases.

Cost Structure

Low R&D expenses due to generic status. Marketing costs are minimal, primarily for regional promotion.

Profitability

Margins are thin as generic competition drives prices down. Companies with existing dermatology portfolios derive limited incremental revenue from clocortolone pivalate.

Critical Market Influencers

• Regulatory approvals: Key to market expansion.
• Patent expiration: Accelerates generic entry.
• Regional healthcare policies: Impact prescribing habits and reimbursement.
• Competitive dynamics: Larger companies may introduce derivative or combination formulations.

What are the Risks and Opportunities?

Risks	Opportunities
Patent expiry leads to generic price erosion	Growing skin disease prevalence in emerging markets
Regulatory hurdles in new regions	Potential for combination therapies
Limited pipeline development	Increasing awareness and education in dermatology

Final Considerations

Clocortolone pivalate enters a mature, low-growth segment with moderate revenue potential. Market expansion hinges on regulatory approvals and regional prescribing habits, while generic competition limits profit margins.

Key Takeaways

• The drug is approved mainly in Europe and select Asian markets, with no FDA approval.
• The global market was approximately $75 million in 2022, with a projected CAGR of 4–5%.
• Patent expiration has facilitated generic entry, suppressing margins.
• Growth driven by regional approvals, prevalence of dermatological conditions, and expanding healthcare access in emerging markets.
• Limited R&D and pipeline activity reduce future growth prospects.

FAQs

1. Is clocortolone pivalate available in the United States?
No, it is not approved by the FDA and has limited or no market presence there.

2. What factors influence the drug’s sales in Europe?
Approval status, regional prescribing habits, competition from generics, and healthcare policies.

3. Are there any ongoing clinical trials for new uses of clocortolone pivalate?
No significant trials are publicly reported; development focus appears minimal.

4. How does the pricing compare to other topical corticosteroids?
Pricing is generally lower due to generic competition but varies regionally.

5. What is the potential for growth in emerging markets?
Moderate; growth depends on approval processes, dermatology disease prevalence, and healthcare infrastructure expansion.

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References

[1] European Medicines Agency. (2022). Clocortolone pivalate marketing authorization information. EMA.
[2] MarketWatch. (2023). Dermatology drug market size and forecasts.
[3] GlobalData. (2022). Topical corticosteroids market analysis.
[4] FDA. (2022). Drug approvals and reviews.
[5] IMS Health. (2022). Dermatology prescription trends.