TOPICORT Drug Patent Profile

When do Topicort patents expire, and what generic alternatives are available?

Topicort is a drug marketed by Taro and Sun Pharma Canada and is included in ten NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has four patent family members in four countries.

The generic ingredient in TOPICORT is desoximetasone. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the desoximetasone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Topicort

A generic version of TOPICORT was approved as desoximetasone by PADAGIS ISRAEL on July 1^st, 2003.

Summary for TOPICORT

International Patents:	4
US Patents:	2
Applicants:	2
NDAs:	10
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	4
Drug Prices:	Drug price information for TOPICORT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TOPICORT
What excipients (inactive ingredients) are in TOPICORT?	TOPICORT excipients list
DailyMed Link:	TOPICORT at DailyMed

See drug prices for TOPICORT

See drug sales revenues for TOPICORT

Recent Clinical Trials for TOPICORT

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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 4
Psoriasis Treatment Center of Central New Jersey	Phase 4
Taro Pharmaceuticals USA	Phase 4

See all TOPICORT clinical trials

Pharmacology for TOPICORT

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for TOPICORT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TOPICORT	Topical Spray	desoximetasone	0.25%	204141	1	2013-12-18

US Patents and Regulatory Information for TOPICORT

TOPICORT is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	TOPICORT	desoximetasone	CREAM;TOPICAL	073210-001	Nov 30, 1990	AB	RX	No	Yes
Taro	TOPICORT	desoximetasone	OINTMENT;TOPICAL	074286-001	Jun 7, 1996		DISCN	No	No
Taro	TOPICORT	desoximetasone	GEL;TOPICAL	074904-001	Jul 14, 1998	AB	RX	No	Yes
Taro	TOPICORT	desoximetasone	OINTMENT;TOPICAL	018763-001	Sep 30, 1983		DISCN	Yes	No
Taro	TOPICORT	desoximetasone	CREAM;TOPICAL	073193-001	Nov 30, 1990	AB	RX	No	Yes
Taro	TOPICORT	desoximetasone	CREAM;TOPICAL	017856-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Taro	TOPICORT	desoximetasone	OINTMENT;TOPICAL	018594-001	Jan 17, 1985	AB	RX	Yes	Yes

Expired US Patents for TOPICORT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharma Canada	TOPICORT	desoximetasone	SPRAY;TOPICAL	204141-001	Apr 11, 2013	5,990,100

International Patents for TOPICORT

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

Country	Patent Number	Title	Estimated Expiration
Canada	2609579	PREPARATION LIQUIDE STABLE COMPRENANT DE LA DESOXYMETASONE ET DU MYRISTATE ISOPROPYLIQUE A TENEUR REDUITE EN IMPURETES OXYDEES EN CAS DE STOCKAGE DE LONGUE DUREE (STABLE LIQUID DESOXIMETASONE COMPOSITIONS WITH REDUCED OXIDIZED IMPURITY)
European Patent Office	1888026	PREPARATION LIQUIDE STABLE COMPRENANT DE LA DESOXYMETASONE ET DU MYRISTATE ISOPROPYLIQUE A TENEUR REDUITE EN IMPURETES OXYDEES EN CAS DE STOCKAGE DE LONGUE DUREE (A STABLE LIQUID FORMULATION COMPRISING DESOXIMETASONE AND ISOPROPYL MYRISTATE WITH REDUCED OXIDIZED IMPURITY DURING LONG-TERM STORAGE)
World Intellectual Property Organization (WIPO)	2006130510
Israel	187666	הרכב נוזלי ויציב של דסוקסימטאסון ואיזופרופיל מיריסטט עם רמת זיהומים מחומצנים פחותה במהלך איחסון ארוך טווח (Stable liquid formulation comprising desoximetasone and isopropyl myristate with reduced oxidized impurity during long-term storage)

Market Dynamics and Financial Trajectory for TOPICORT

Last updated: July 31, 2025

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Introduction

TOPICORT (generic name: clobetasol propionate), a potent topical corticosteroid, is widely prescribed for managing inflammatory and pruritic skin disorders such as psoriasis, eczema, and dermatitis. Understanding the market dynamics and financial trajectory of TOPICORT requires a comprehensive analysis of regulatory environment, competitive landscape, market demand, innovation pipeline, and global access patterns. This detailed assessment aims to inform business decisions, investment strategies, and stakeholder management within this lucrative segment of dermatological therapeutics.

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Regulatory and Patent Landscape

The regulatory environment heavily influences TOPICORT's market trajectory. As a topical corticosteroid with a well-established safety and efficacy profile, it previously benefited from patent protections that limited generic competition. However, patent expirations across major markets—such as the U.S. in 2020—have accelerated the introduction of generic equivalents, intensifying market competition [1].

Regulatory hurdles vary geographically. In the U.S., the FDA’s abbreviated new drug application (ANDA) pathway facilitates generic approvals post-patent expiry, fostering rapid market entry. Conversely, markets such as Europe impose stricter bioequivalence requirements, affecting timing and pricing strategies. Additionally, ongoing concerns over corticosteroid overuse and associated side effects prompt regulatory agencies to enforce stricter labeling and usage guidelines, impacting prescribing patterns [2].

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Market Demand and Therapeutic Area Trends

The demand for TOPICORT remains buoyed by its positioning as a first-line therapy in dermatology, especially for moderate to severe inflammatory skin conditions. The global dermatology therapeutics market, projected to reach $46 billion by 2027, underscores significant growth potential [3].

Factors propelling demand include:

• Prevalence of skin disorders: An estimated 2-3% of the global population suffers from psoriasis, with eczema affecting approximately 10-20% of children and 3% of adults worldwide [4].
• Aging demographics: Increased age-related dermatological conditions drive prescription rates.
• Rising awareness and diagnosis: Enhanced dermatological healthcare access amplifies prescription frequency.
• Off-label use and combination formulations: Expanding therapeutic indications maintain momentum in usage.

However, concerns over long-term corticosteroid use, such as skin atrophy and systemic absorption, have prompted clinicians to limit potency and duration, influencing market volume.

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Competitive Landscape and Market Share Dynamics

Following patent expirations, the market experienced a surge in generic clobetasol propionate formulations. Major players include Mylan (now part of Viatris), Sun Pharma, Dr. Reddy’s Laboratories, and Sandoz, which has intensified competition through price competition and distribution channels. The entry of biosimilars and formulations with improved delivery systems (e.g., foam, lotion) further fragments market share.

Brand-name products like Temovate (manufactured by Valeant Pharmaceuticals), although historically dominant, now face stiff generic competition that has driven down prices substantially. Manufacturers employing aggressive bidding, rebate strategies, and expanded distribution networks have increased their penetration in developing regions, where healthcare infrastructure is evolving.

The competitive environment has shifted from premium pricing to volume-driven sales, especially as healthcare payers seek cost-effective options. Consequently, profit margins for manufacturers have compressed, emphasizing operational efficiency.

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Emerging Innovations and R&D Outlook

Innovation in topical corticosteroids is minimal; the primary trends involve optimizing delivery methods and safety profiles. Recent R&D efforts focus on:

• Novel formulations: Foam, gel, and sheet-based preparations aim to improve patient compliance and drug absorption.
• Combination therapies: Incorporating anti-inflammatory agents with moisturizers or antimicrobial agents enhances efficacy and reduces systemic corticosteroid exposure [5].
• Reduced potency options: Development of lower-potency formulations helps address safety concerns while broadening indication spectrum.

While there is limited pipeline activity directly targeting TOPICORT, adjacent innovations in dermatology, including biologics and targeted immunomodulators, could indirectly influence market share in severe or resistant cases.

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Global Market Access and Pricing Dynamics

Emerging markets, notably India, China, and Latin America, represent significant growth opportunities due to rising dermatological conditions and expanding healthcare infrastructure. Generic availability aligns with affordability drives, given government and insurance reimbursement policies favor cost-effective therapeutics.

Price erosion, however, poses threat to profit margins. The U.S. market exemplifies this, with prices declining by approximately 40% since patent expirations due to intense generic competition. Conversely, in markets with regulatory hurdles and limited local manufacturing, branded products retain premium pricing advantages.

Market access strategies such as licensing, local manufacturing, and Tiered pricing are prevalent to navigate diverse regulatory landscapes.

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Financial Trajectory and Investment Outlook

The financial prospects of TOPICORT are characterized by short- and long-term considerations:

• Post-patent expiry: Rapid decline in branded sales, replaced by lower-priced generics. The U.S. market experienced an average price erosion of nearly 50% within two years post-patent expiry [6].
• Market saturation: Mature markets see stabilization or decline, shifting focus to emerging regions.
• Growth opportunities: Expansion in developing countries, especially through affordability-driven strategies, sustains revenue flow. Additionally, the adoption of innovative formulations can command premium pricing, partially offsetting volume reductions.

Profitability hinges on operational efficiency, supply chain management, and strategic alliances. Companies investing in manufacturing scalability and regulatory navigation are poised to capitalize on volume gains.

Forecasts suggest a gradual decline in premium branded TOPICORT sales over the next five years, with total market value stabilizing in the $1-2 billion range globally, driven mainly by generic volume and emerging markets.

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Risks and Market Challenges

Key risks influencing TOPICORT's financial path include:

• Regulatory restrictions: Safety concerns may prompt restrictive labeling or usage limitations.
• Pricing pressures: Payer pushback and formulary exclusions threaten margins.
• Market saturation: Excess supply and generic competition depress prices.
• Safety concerns: Long-term corticosteroid side effects may result in class-wide usage restrictions.

These factors demand continuous monitoring and strategic agility among stakeholders.

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Conclusion

The market dynamics and financial trajectory for TOPICORT reflect a mature but evolving landscape. Patent expirations ushered in an era of competition, reducing profitability for branded products and favoring cost-sensitive generics. Innovation efforts are primarily centered on delivery systems and safety profiles, with limited pipeline activity directly targeting TOPICORT.

Global expansion, especially into emerging markets, remains crucial for sustaining revenue streams. Companies capable of balancing cost efficiencies with strategic innovation and regulatory compliance will effectively navigate the post-patent era.

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Key Takeaways

• Patent expiries drastically increased generic competition, compressing profit margins for TOPICORT.
• Market demand remains robust across the globe, driven by dermatological prevalence and aging populations.
• Competitive landscape is ascending in intensity, with aggressive pricing and diversified formulations.
• Innovation focus is on delivery methods and safety, with limited pipeline activity directly in the corticosteroid space.
• Future prospects hinge on strategic expansion into emerging markets, operational efficiencies, and safety profile enhancements.

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FAQs

1. What is the primary factor affecting TOPICORT’s market share post-patent expiration?
   Patent expiration opened the market to generic competitors, causing pricing pressures and loss of exclusive market share previously held by branded formulations.

2. How are emerging markets influencing TOPICORT’s global sales?
   With increasing healthcare infrastructure and demand for affordable dermatological treatments, emerging markets present significant growth opportunities for both generic and branded products.

3. What innovations are companies implementing to maintain competitiveness?
   Focus is on developing user-friendly formulations such as foams and gels, combining corticosteroids with other actives, and improving safety profiles to attract prescribers and patients.

4. What are the main risks faced by companies in the TOPICORT market?
   Regulatory restrictions, escalating pricing pressures, safety concerns, and oversupply in mature markets threaten long-term profitability.

5. What is the outlook for TOPICORT’s financial trajectory over the next five years?
   Expect declining revenues in developed markets due to generic competition, while revenues in emerging markets may grow. Strategic diversification and innovation could stabilize overall market returns.

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Sources
[1] U.S. FDA. "Generic Drugs: Fact Sheet."
[2] European Medicines Agency. "Guidelines on Safety and Usage."
[3] Grand View Research. "Dermatology Therapeutics Market Size & Forecast."
[4] World Health Organization. "Epidemiology of Skin Disorders."
[5] Journal of Dermatological Treatment. "Advances in Topical Corticosteroid Formulations."
[6] IQVIA. "Market Trends Post-Patent Expiry."