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-four 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
VA Office of Research and Development	N/A
University Hospitals Cleveland Medical Center	N/A
University of Utah	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

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	3,721,687
Fougera Pharms	TEMOVATE	clobetasol propionate	OINTMENT;TOPICAL	019323-001	Dec 27, 1985	3,721,687
Fougera Pharms	TEMOVATE	clobetasol propionate	SOLUTION;TOPICAL	019966-001	Feb 22, 1990	3,721,687

International Patents for TEMOVATE

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

Country	Patent Number	Title	Estimated Expiration
Norway	132100
Netherlands	7811738
Netherlands	6900795
Spain	362679

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TEMOVATE

Last updated: July 27, 2025

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Introduction

TEMOVATE, with the generic name clobetasol propionate, is a potent topical corticosteroid predominantly used to treat inflammatory and pruritic manifestations of various skin diseases, including psoriasis, eczema, and dermatitis. As a high-potency steroid, TEMOVATE holds a significant position within dermatological therapeutics, influencing both clinical practices and pharmaceutical markets. This analysis explores the evolving market dynamics and financial trajectory of TEMOVATE, considering regulatory landscapes, competitive forces, patent statuses, and emerging trends shaping its market outlook.

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Regulatory Landscape and Patent Status

TEMOVATE’s active ingredient, clobetasol propionate, has been well established in the dermatology space since its initial approval. Its patent shield has largely expired or is nearing expiration in many jurisdictions, enabling generic manufacturers to enter the market. In the United States, for example, Teva Pharmaceuticals has launched generic versions post patent expiry, intensifying price competition [1].

Regulatory acceptance of generics often leads to significant price erosion but increases drug accessibility. Conversely, the original branded product, under its proprietary name, maintains premium pricing, particularly in regions where regulatory exclusivity persists or where generics face market-entry barriers.

Current patent expirations and exclusivity periods significantly influence the market share distribution, with generics increasingly capturing the demand traditionally held by branded TEMOVATE. The expiration timeline varies globally, but in mature markets like North America and Europe, generic penetration is robust, exerting downward pressure on pricing and revenue streams [2].

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Market Demand Drivers

Demand for TEMOVATE remains driven by:

• Prevalence of dermatological conditions: Psoriasis and eczema continue to affect large population segments worldwide, with estimates indicating over 125 million psoriasis sufferers globally [3]. Growing awareness and diagnosis rates sustain elevated demand.

• Physician preferences for potent corticosteroids: While potent corticosteroids are effective, prudent use limitations are enforced due to potential side effects such as skin atrophy and HPA axis suppression. Nevertheless, physicians prescribe TEMOVATE for acute management, influencing steady demand.

• Patient compliance: The efficacy of topical corticosteroids results in high patient satisfaction, fostering consistent use.

• Regional healthcare infrastructure: Developed regions with advanced dermatology practices exhibit higher prescription rates of potent steroids. In contrast, emerging markets witness rising demand due to increasing skin disease prevalence and improving healthcare access.

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Market Competition and Price Dynamics

The market landscape for TEMOVATE is highly competitive, characterized by:

• Generic proliferation: After patent expiration, numerous manufacturers introduce similar formulations at reduced pricing, challenging the brand’s pricing power. This has led to a significant decline in branded sales and margin compression.

• Alternative therapies: The emergence of newer topical agents such as calcineurin inhibitors (e.g., tacrolimus) and biologics for severe cases diversifies treatment options, potentially affecting demand.

• Formulation innovations: Advances in delivery systems, such as foam or lotion formulations, aim to improve patient compliance, yet also fragment the market.

Price competition, primarily driven by generics, reduces margins for original manufacturers. According to IQVIA data, the U.S. retail market for topical corticosteroids decreased by approximately 40% following patent expiries [4].

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Emerging Trends and Market Forces

Several trends are shaping the future trajectory of TEMOVATE:

• Regulatory shifts towards corticosteroid stewardship: Concerns over systemic side effects from potent topical steroids have led to tighter prescribing guidelines, especially in Europe. These restrictions influence demand and prescribing practices [5].

• Increased emphasis on safety and long-term use: Companies may develop formulations with lower potency or combination products to mitigate adverse effects, impacting demand for high-potency options like TEMOVATE.

• Market consolidation: Larger pharmaceutical firms acquiring dermatology portfolios may influence distribution dynamics and pricing strategies.

• Incorporation of digital health tools: Teledermatology and AI-enhanced diagnostics improve disease management but may alter treatment pathways and prescribing behaviors, affecting drug utilization.

• Focus on developing markets: Rapid population growth and rising skin disease prevalence in Asia, Latin America, and Africa present growth opportunities, albeit with pricing sensitivity.

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Financial Trajectory Analysis

The financial outlook for TEMOVATE hinges on:

• Revenue decline in mature markets: As generics dominate, branded sales diminish. Companies relying solely on TEMOVATE for revenue will face declining profit margins unless diversified.

• Growth opportunities in emerging markets: Entry into developing economies can offset mature market declines. Cost-effective manufacturing and local partnerships will be pivotal.

• R&D investments and pipeline prospects: Innovation around steroid formulations or alternative MoAs may prolong market relevance, influencing future revenue streams.

• Pricing strategies: Patent expiries demand strategic response, balancing access and profit. Tiered pricing, patient assistance programs, and combination therapies may sustain revenues.

Industry estimates project a compound annual decline rate (CAGR) of around 10-12% for branded corticosteroids like TEMOVATE in mature markets over the next five years, primarily driven by generic market shares [6]. However, growth in emerging economies and the introduction of novel formulations could moderate this decline.

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Conclusion

The market dynamics surrounding TEMOVATE are complex, characterized by patent expiry-driven competition, evolving treatment guidelines, and regional demand variations. While traditional markets face declining revenues due to generic entries, emerging markets present growth avenues. The financial trajectory underscores a transition from branded sales dominance to a landscape influenced heavily by generics, regulatory policies, and innovation. Stakeholders must adopt adaptive strategies encompassing portfolio diversification, cost management, and regional expansion to optimize value realization.

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Key Takeaways

• Patent expirations significantly reduce branded TEMOVATE’s market share in mature markets, with aggressive generic competition leading to price erosion and margin compression.

• Growing global skin disease prevalence, especially in developing countries, offers growth opportunities, contingent on market entry strategies and local regulatory compliance.

• Regulatory and safety considerations influence prescribing patterns, potentially favoring lower-potency alternatives or combination therapies, impacting future demand.

• Innovation in formulations and delivery systems could extend product relevance and open new revenue streams.

• Strategic diversification and geographic expansion are essential for sustained financial performance amid declining branded sales.

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FAQs

1. What factors contributed to TEMOVATE’s market decline?
   Patent expiration, widespread generic manufacturing, and regulatory restrictions on potent corticosteroid use have led to decreased branded sales and aggressive pricing in key markets.

2. Are there therapeutic alternatives to TEMOVATE?
   Yes. Alternatives include lower-potency topical corticosteroids, calcineurin inhibitors, physical therapies, and biologics for severe cases, influencing demand dynamics.

3. How does regional variability affect TEMOVATE’s market?
   Developed markets exhibit rapid generic penetration and regulatory controls, reducing revenues, while emerging markets present growth potential with different pricing sensitivities.

4. What emerging trends could extend the life cycle of TEMOVATE?
   Innovations in drug delivery systems, combination products, and formulations with improved safety profiles may help retain market relevance.

5. What strategic moves are recommended for stakeholders?
   Diversify product portfolios, pursue emerging market expansion, invest in formulation innovation, and adapt to evolving regulatory protocols to sustain financial performance.

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References

1. [FDA Patent Status of Clobetasol Propionate Products](https://www.fda.gov/drugs/patents- exclusivity-and-competition/).

2. IQVIA, Topical Corticosteroids Market Analysis, 2022.

3. World Psoriasis Atlas, Global Prevalence and Burden, 2021.

4. IQVIA, Impact of Patent Expiry on Corticosteroid Market, 2021.

5. European Medicines Agency, Guidelines on Potent Corticosteroids, 2020.

6. Pharma Intelligence, Future Trends in Dermatology Market, 2022.