DESOXIMETASONE - Generic Drug Details

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

Desoximetasone is the generic ingredient in three branded drugs marketed by Actavis Mid Atlantic, Cosette, Fougera Pharms, Lupin, Padagis Israel, Rising, Sciegen Pharms Inc, Zydus Lifesciences, Taro, Epic Pharma Llc, Padagis Us, Altana, Glenmark Pharms Ltd, Novel Labs Inc, Pai Holdings Pharm, The J Molner, and Sun Pharma Canada, and is included in forty NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Desoximetasone has four patent family members in four countries.

There are seven drug master file entries for desoximetasone. Twelve suppliers are listed for this compound.

Summary for DESOXIMETASONE

International Patents:	4
US Patents:	2
Tradenames:	3
Applicants:	17
NDAs:	40
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	10
Patent Applications:	7,811
Drug Prices:	Drug price trends for DESOXIMETASONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DESOXIMETASONE
What excipients (inactive ingredients) are in DESOXIMETASONE?	DESOXIMETASONE excipients list
DailyMed Link:	DESOXIMETASONE at DailyMed

See drug prices for DESOXIMETASONE

See drug sales revenues for DESOXIMETASONE

Recent Clinical Trials for DESOXIMETASONE

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
Siriraj clinical research center	Phase 3

See all DESOXIMETASONE clinical trials

Pharmacology for DESOXIMETASONE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for DESOXIMETASONE

Anti-Inflammatory Agents

Glucocorticoids

Anatomical Therapeutic Chemical (ATC) Classes for DESOXIMETASONE

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XC	Corticosteroids, potent, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for DESOXIMETASONE

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 DESOXIMETASONE

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	GEL;TOPICAL	018586-001	Mar 29, 1982		DISCN	Yes	No
Taro	TOPICORT	desoximetasone	OINTMENT;TOPICAL	018594-001	Jan 17, 1985	AB	RX	Yes	Yes
Padagis Israel	DESOXIMETASONE	desoximetasone	OINTMENT;TOPICAL	077770-001	Apr 20, 2015	AB	RX	No	No
Padagis Us	DESOXIMETASONE	desoximetasone	GEL;TOPICAL	077552-001	Jan 9, 2006	AB	RX	No	No
Glenmark Pharms Ltd	DESOXIMETASONE	desoximetasone	OINTMENT;TOPICAL	202838-001	Sep 20, 2013		DISCN	No	No
Actavis Mid Atlantic	DESOXIMETASONE	desoximetasone	CREAM;TOPICAL	205082-001	Sep 4, 2015	AB	RX	No	No
Lupin	DESOXIMETASONE	desoximetasone	OINTMENT;TOPICAL	208104-001	Dec 1, 2016	AB	RX	No	No

Expired US Patents for DESOXIMETASONE

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 DESOXIMETASONE

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)
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)
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DESOXIMETASONE

Last updated: July 27, 2025

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Introduction

Desoximetasone is a potent topical corticosteroid primarily prescribed for inflammatory and allergic skin conditions, including psoriasis, eczema, and dermatitis. Recognized for its anti-inflammatory, antipruritic, and vasoconstrictive properties, desoximetasone is marketed under various brand names globally. Understanding its market dynamics and financial trajectory entails analyzing clinical efficacy, regulatory landscape, competitive positioning, and evolving healthcare trends influencing its demand and revenue generation.

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Pharmacological Profile and Therapeutic Indications

Desoximetasone acts by suppressing inflammatory cell migration and reversing capillary dilation, thereby reducing redness, swelling, and itching associated with dermatological conditions. Its high potency class positions it against other corticosteroids such as clobetasol propionate; however, its safety profile, especially risk of skin atrophy and systemic absorption, determines usage limitations [1].

Therapeutically, it chiefly targets moderate to severe inflammatory skin disorders. The drug's topical application offers localized relief with minimal systemic exposure, making it preferred in scenarios requiring stringent safety controls.

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Market Size and Growth Drivers

The global dermatological therapeutics market, valued at approximately USD 23 billion in 2022, is projected to grow at a CAGR of around 6.2% through 2030 [2]. A key segment within this is corticosteroid-based medications, including desoximetasone.

Several catalysts underpin the market's upward trajectory:

• Rising Prevalence of Skin Disorders: The increasing incidence of psoriasis, eczema, and contact dermatitis driven by lifestyle changes, pollution, and urbanization amplifies demand. Data indicates psoriasis affects over 125 million worldwide, with a rising trend in developing countries [3].

• Advancement in Formulations: Innovations such as ultra-potent formulations, combined therapies, and novel delivery systems (e.g., foam, cream) elevate treatment adherence and efficacy.

• Aging Population: Elderly demographics exhibit higher susceptibility to chronic dermatological conditions, stimulating sustained demand.

• Growing Awareness and Healthcare Access: Enhanced awareness initiatives and expanding healthcare infrastructure, especially in emerging markets, facilitate broader prescription and over-the-counter availability.

Competitive Landscape

Desoximetasone faces competition from both other potent corticosteroids and alternative therapeutic classes. Market players include Novartis, Mylan, and Teva Pharmaceuticals, offering formulations under various brand names like Topicort (Lederle/AbbVie) and others.

In addition to generic entries, the patent expiry of earlier corticosteroids has led to increased generic penetration, intensifying price competition. Notably, generic versions account for a significant market share, contributing to reduced pricing but also expanding patient accessibility [4].

Emerging biologic therapies targeting underlying immune pathways (e.g., IL-17 inhibitors for psoriasis) challenge corticosteroid dominance but remain primarily in the systemic or injectable category, giving topical corticosteroids a continued niche.

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Regulatory Framework & Market Accessibility

Regulatory agencies such as the FDA, EMA, and other national bodies necessitate rigorous safety and efficacy data prior to approval. Desoximetasone’s high potency classification invites strict prescribing guidelines, with limitations on duration and application area to mitigate adverse effects.

The ease of over-the-counter availability varies globally, often influenced by safety considerations. While many markets restrict potent corticosteroids to prescriptions, expanding access in emerging economies remains a strategic focus, potentially increasing consumption volumes.

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Financial Trajectory & Revenue Outlook

Financial projections for desoximetasone hinge on several factors:

• Patent and Formulation Lifecycle: With patents having expired or nearing expiry, revenue streams face downward pressure due to generics. However, formulation innovations and new combination therapies offer pathways for revenue retention.

• Market Penetration and Pricing Strategies: Companies leveraging aggressive pricing, targeted marketing, and expanding regional presence can offset volume declines and sustain margins.

• Expanding Indications: Research exploring off-label uses or adjunct indications could open new markets, although such avenues require regulatory substantiation.

• Regional Growth: Developing economies are expected to contribute proportionally to revenues owing to increasing dermatological condition prevalence and expanding healthcare access.

For example, a leading pharmaceutical company reported that topical corticosteroids, including desoximetasone, composed approximately 15% of its dermatology segment revenue in 2022. Given the market trends, a compounded annual decline of 2-3% is anticipated for branded desoximetasone products post-patent expiry, whereas generics could see a volume-driven increase.

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Market Challenges and Risks

Despite positive growth prospects, several challenges threaten market stability:

• Safety Concerns & Regulatory Restrictions: Adverse effects associated with potent corticosteroids, including skin thinning and systemic toxicity, lead to tighter use guidelines.

• Pricing Pressures & Generics: Heightened competition from generics diminishes profit margins and presses manufacturers to innovate.

• Emerging Alternatives: Biologics and non-steroid topical agents (e.g., calcineurin inhibitors) could supplant corticosteroids in certain indications, impacting long-term demand.

• Regulatory Hurdles in Emerging Economies: Variations in approval processes/requirements can delay market entry or expansion plans.

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Future Outlook & Strategic Considerations

The future landscape for desoximetasone is characterized by a shift toward tailored therapies and combination formulations. Companies are investing in:

• Novel Delivery Systems: Improving drug stability, reducing adverse effects, and enhancing patient compliance.

• Combination Therapies: Pairing corticosteroids with antimicrobials or moisturizers to extend indications and treatment efficacy.

• Digital & Teledermatology: Leveraging remote consultation channels can increase prescription efficiency and patient adherence.

• Market Expansion in Asia-Pacific and Latin America: These regions promise growth owing to rising disease prevalence and healthcare investments.

In the longer term, the transition from potent corticosteroids to safer, targeted therapies may influence desoximetasone’s market share. Nonetheless, its affordability and well-established efficacy ensure it remains a vital component in dermatological pharmacotherapy.

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Key Takeaways

• The demand for desoximetasone is driven by rising dermatological conditions, aging populations, and formulation innovations, anchoring a steady growth trajectory despite patent expiries.

• Competitive forces, especially generic entries, exert downward pressure on revenues, compelling manufacturers to innovate in delivery and combination therapies.

• Regulatory frameworks influence market accessibility, with stricter prescribing guidelines protecting patient safety but potentially limiting growth in some regions.

• The expanding role of biologics and alternative agents presents both challenges and opportunities for desoximetasone’s positioning.

• Strategic investments in formulation technology, regional expansion, and maintaining safety profiles are critical for sustaining profitability.

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FAQs

1. What are the main therapeutic uses of desoximetasone?
Desoximetasone is primarily prescribed for inflammatory skin conditions such as psoriasis, eczema, and dermatitis, where it alleviates redness, swelling, and itching.

2. How does patent expiry impact desoximetasone's market?
Patent expiration often leads to increased generic competition, reducing prices and profit margins while expanding access. Companies may counter this with formulation innovations and new indications.

3. Are there safety concerns with using desoximetasone?
Yes. Potent corticosteroids like desoximetasone can cause skin atrophy, telangiectasia, and systemic effects if misused. Regulatory agencies impose strict prescribing guidelines to mitigate risks.

4. What emerging therapies could threaten desoximetasone's market share?
Biological agents targeting immune pathways (e.g., IL-17 inhibitors) and non-steroidal topical agents are emerging alternatives for certain conditions.

5. What regions offer the most growth opportunities for desoximetasone?
Emerging markets in Asia-Pacific, Latin America, and Africa are poised for growth due to increasing disease prevalence, improving healthcare infrastructure, and expanding medication access.

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References

[1] Pharmacology and safety profile of topical corticosteroids. Journal of Dermatological Treatment. 2020.

[2] Global dermatology therapeutics market report. MarketResearch.com. 2022.

[3] Epidemiology of psoriasis worldwide. National Psoriasis Foundation. 2021.

[4] Impact of generic entry on corticosteroid markets. Pharmaceutical Market Analysis. 2022.