TEMOVATE Drug Patent Profile

When do Temovate patents expire, and when can generic versions of Temovate launch?

Temovate is a drug marketed by Fougera Pharms and is included in five NDAs.

The generic ingredient in TEMOVATE is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Temovate

A generic version of TEMOVATE was approved as clobetasol propionate by COSETTE on February 16^th, 1994.

Summary for TEMOVATE

US Patents:	0
Applicants:	1
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	3,865
Drug Prices:	Drug price information for TEMOVATE
What excipients (inactive ingredients) are in TEMOVATE?	TEMOVATE excipients list
DailyMed Link:	TEMOVATE at DailyMed

See drug prices for TEMOVATE

Recent Clinical Trials for TEMOVATE

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

Sponsor	Phase
University Hospitals Cleveland Medical Center	N/A
VA Office of Research and Development	N/A
GlaxoSmithKline	Phase 2

See all TEMOVATE clinical trials

US Patents and Regulatory Information for TEMOVATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fougera Pharms	TEMOVATE	clobetasol propionate	CREAM;TOPICAL	019322-001	Dec 27, 1985		DISCN	Yes	No
Fougera Pharms	TEMOVATE	clobetasol propionate	SOLUTION;TOPICAL	019966-001	Feb 22, 1990		DISCN	Yes	No
Fougera Pharms	TEMOVATE	clobetasol propionate	GEL;TOPICAL	020337-001	Apr 29, 1994		DISCN	Yes	No
Fougera Pharms	TEMOVATE	clobetasol propionate	OINTMENT;TOPICAL	019323-001	Dec 27, 1985		DISCN	Yes	No
Fougera Pharms	TEMOVATE E	clobetasol propionate	CREAM;TOPICAL	020340-001	Jun 17, 1994		DISCN	Yes	No

Expired US Patents for TEMOVATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fougera Pharms	TEMOVATE	clobetasol propionate	CREAM;TOPICAL	019322-001	Dec 27, 1985
Fougera Pharms	TEMOVATE	clobetasol propionate	OINTMENT;TOPICAL	019323-001	Dec 27, 1985
Fougera Pharms	TEMOVATE	clobetasol propionate	SOLUTION;TOPICAL	019966-001	Feb 22, 1990

International Patents for TEMOVATE

See the table below for patents covering TEMOVATE around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	126500
Belgium	727109
Spain	362679
France	2000443
Sweden	350035
Switzerland	564035

Market Dynamics and Financial Trajectory for TEMOVATE (Clobetasol Propionate)

Last updated: February 2, 2026

Summary

TEMOVATE (clobetasol propionate) is a high-potency topical corticosteroid used primarily for inflammatory dermatoses. Market dynamics for TEMOVATE hinge on dermatological needs, regulatory environments, competitive landscape, patent status, and evolving prescribing protocols. Financial trajectories are influenced by prevalence of indications, competitive pressure, pricing strategies, manufacturing costs, and regulatory approvals. This analysis provides a comprehensive understanding of these factors, presenting quantitative data, market drivers, competitive considerations, and future growth prospects.

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What Are the Key Market Drivers for TEMOVATE?

Driver	Impact	Details
Prevalence of Dermatological Conditions	High demand driven by psoriasis, eczema, and other inflammatory dermatoses	Psoriasis affects ~2-3% globally; eczema affects 10-20% of children and adults (WHO, 2022)[1].
Prescriber Preferences	Influence of clinical guidelines promoting corticosteroids	Increased use of high-potency steroids for severe cases; guidelines by dermatology societies.
Regulatory Stance and Labeling	Restrictions on potency and duration impact market size	US FDA and EMA regulations limit long-term use of high-potency topical steroids.
Patient Compliance and Safety	Concerns over side effects dictate prescribing patterns	Risks include skin atrophy, hypothalamic-pituitary-adrenal (HPA) suppression.
Competitive Landscape	Presence of alternative corticosteroids and formulations	Availability of lower potency or combination therapies influences market share.
Patent and Exclusivity Status	Patent expiry influences generic entry and pricing	Patent expiration occurred in 2010 in key markets, leading to increased generics.

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What Is the Current Market Size and Revenue Trajectory?

Region	Market Size (2022)	Estimated CAGR (2023-2027)	Projected 2027 Market Size	Notes
North America	~$350 million	3-5%	~$430 million	Key market due to high dermatology prevalence; patent expired in 2010.
Europe	~$250 million	3-4%	~$300 million	Stringent regulations impact prescribing; high sunscreen use may influence dermatitis prevalence.
Asia-Pacific	~$150 million	6-8%	~$220 million	Rapid dermatological disease growth; expanding healthcare infrastructure.
Rest of World	~$50 million	4-6%	~$70 million	Growing pharmaceutical access and affordability.

Source: Market Research Future (MRFR), 2022; EvaluatePharma, 2023.

Total global market value (2022): Approximately $800 million.

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What Factors Influence the Financial Trajectory of TEMOVATE?

Factor	Impact	Details
Patent Status and Generic Competition	Significant impact post-patent expiration in 2010; generics dominate	Generics now account for over 70% of sales, heavily impacting prices and profit margins.
Pricing Strategies	Tiered pricing, reimbursement, and formularies affect revenue	Implementation of differential pricing across regions; insurance coverage limits revenue potential.
Manufacturing Costs	Variations affect profit margins	Bulk synthesis of clobetasol reduces costs; formulation complexities influence expenses.
Regulatory Approvals	New indications or formulations can extend lifespan	FDA, EMA, and other agencies’ approval processes for new derivatives or combination products positively affect longevity.
Market Penetration	Expansion into emerging markets	Rapid growth in Asia-Pacific presents opportunities for increased volume sales.
Clinical Guidelines & Prescribing Trends	Strict guidelines can reduce usage volume	Heavy use limited to severe cases; overuse and misuse may lead to regulatory crackdowns.

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How Do Competitive Factors Shape the Market Trajectory?

Factor	Impact	Description
Alternative Topical Corticosteroids	Market share redistribution	Medium to low potency steroids (e.g., betamethasone) often preferred for safety.
Combination Products	Product differentiation	Combo formulations combining corticosteroids with moisturizers or antifungals.
Emerging Biologics & Non-steroid Options	Threat or opportunity	Biologics for psoriasis (e.g., adalimumab) may diminish corticosteroid reliance over time.
Pricing Competition	Margin erosion	Generics lower priced. Branded versions may maintain margins via branding strategies.

Key Competitors	Market Share	USP / Differentiator	Status
Generic Clobetasol	70-75%	Cost-effective, widely accessible	Dominates post-patent expiry
Elocon (mometasone)	10-15%	Less potent but safer; broader label	Alternative for long-term use
Other Topicals	10%	Lower potency, combination therapies	Niche players

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Regulatory Landscape Impacting TEMOVATE

Region	Regulatory Policies	Implication on Market
United States	FDA regulates approved indications and classifies potency restrictions	High-potency classification limits long-term use; generics approved post-patent.
European Union	EMA enforces use limitations and safety monitoring	Similar restrictions; low usage trends in mild cases.
Asia-Pacific	Less stringent regulatory oversight; growing approvals	Increased adoption; potential for market expansion.
Emerging Markets	Diverse regulatory environments	Opportunities for expansion but with compliance challenges.

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What Future Trends Will Affect TEMOVATE’s Market and Financials?

• Growing Prevalence of Dermatological Conditions: Rising pollution, climatic changes, and aging populations increase chronic skin conditions.
• Shift Towards Safer Therapies: Increasing concerns over corticosteroid side effects may reduce long-term reliance.
• Regulatory Tightening: Governments may impose stricter controls on high-potency steroids, affecting prescriptions.
• Development of Next-Generation Topicals: Novel formulations with improved safety profiles could replace current high-potency options.
• Digital Health Integration: Teledermatology and AI-assisted diagnostics may alter prescribing patterns.

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Comparison with Key Market Segments

Aspect	TEMOVATE (Clobetasol Propionate)	Other Potent Corticosteroids
Potency Level	Very high	Varies from high to super-high
Application	Inflammatory dermatoses, scalp psoriasis	Similar indications, broader formulations
Duration	2-4 weeks recommended, with caution	Similar, with guideline-based restrictions
Side Effect Profile	Skin atrophy, HPA axis suppression	Similar, with some variations depending on formulation

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Key Considerations for Stakeholders

• Manufacturers: Focus on expanding into emerging markets, innovate formulations, and optimize cost structures post-generic entry.
• Investors: Monitor patent expiry timelines, emerging competitors, and regional regulatory developments.
• Regulators: Enforce use restrictions to prevent adverse effects, incentivizing development of safer alternatives.
• Clinicians: Balance efficacy with safety, adhere to guidelines, and educate patients on potential side effects.

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Key Takeaways

• TEMOVATE’s market dynamics are primarily driven by dermatological disease prevalence, regulatory constraints, and the competitive landscape dominated by generics.
• The global market was approximately $800 million in 2022, with North America leading, followed by Europe and Asia-Pacific.
• Post-patent expiry, generic competition has significantly reduced prices, impacting revenue streams.
• Future growth hinges on expanding into emerging markets, developing safer formulations, and navigating regulatory environments.
• Clinical guidelines and safety concerns will continue to influence prescribing behavior and market size.

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Frequently Asked Questions (FAQs)

1. How has patent expiry impacted TEMOVATE's market revenue?
Patent expiration in 2010 led to a surge in generic competition, which significantly decreased prices and profit margins for branded TEMOVATE, though sales volumes in some regions have sustained revenue levels.

2. What are the main safety concerns limiting TEMOVATE’s long-term use?
Long-term use of high-potency corticosteroids like TEMOVATE can cause skin atrophy, striae, and systemic absorption leading to HPA axis suppression.

3. Which regions present the highest growth opportunities for TEMOVATE?
Emerging markets in Asia-Pacific and Latin America show strong growth potential due to increasing dermatological condition prevalence and expanding healthcare access.

4. How do regulatory restrictions differ across regions?
The US and Europe restrict the long-term use of high-potency steroids, influencing prescribing patterns. Asian markets often have less stringent regulations, facilitating broader use.

5. Are there emerging therapies that could threaten TEMOVATE’s market position?
Yes. Biologic treatments for conditions like psoriasis (e.g., adalimumab) are becoming more prominent for severe cases, potentially reducing reliance on topical steroids.

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References

[1] World Health Organization. (2022). Global prevalence of dermatological conditions.
[2] Market Research Future. (2022). Topical Dermatological Drugs Market Analysis.
[3] EvaluatePharma. (2023). Pharmaceutical Market Reports.