DESONIDE - Generic Drug Details

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

Desonide is the generic ingredient in four branded drugs marketed by Almirall, Alembic, Cadila, Cosette, Glenmark Speclt, Padagis Us, Sun Pharma Canada, Galderma Labs Lp, Leo Pharma As, Senores Pharms, Fougera Pharms, Pai Holdings Pharm, Taro, Encube Ethicals, Glenmark Pharms Ltd, and Hikma, and is included in twenty-five NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Desonide has twenty-two patent family members in sixteen countries.

There are thirty-one drug master file entries for desonide. Sixteen suppliers are listed for this compound.

Summary for DESONIDE

International Patents:	22
US Patents:	3
Tradenames:	4
Applicants:	16
NDAs:	25
Drug Master File Entries:	31
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	9
Patent Applications:	7,394
Drug Prices:	Drug price trends for DESONIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DESONIDE
What excipients (inactive ingredients) are in DESONIDE?	DESONIDE excipients list
DailyMed Link:	DESONIDE at DailyMed

See drug prices for DESONIDE

See drug sales revenues for DESONIDE

Recent Clinical Trials for DESONIDE

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

Sponsor	Phase
Can-Fite BioPharma	PHASE3
Procter and Gamble	Phase 3
EMS	Phase 4

See all DESONIDE clinical trials

Pharmacology for DESONIDE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for DESONIDE

Anti-Inflammatory Agents

Anatomical Therapeutic Chemical (ATC) Classes for DESONIDE

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

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for DESONIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DESONATE	Gel	desonide	0.05%	021844	1	2010-12-01

US Patents and Regulatory Information for DESONIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	DESONIDE	desonide	CREAM;TOPICAL	074027-001	Sep 28, 1992	AB	RX	No	No
Hikma	DESONIDE	desonide	OINTMENT;TOPICAL	208836-001	Mar 27, 2017		DISCN	No	No
Almirall	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006		DISCN	Yes	No	8,460,641		Y
Sun Pharma Canada	DESONIDE	desonide	CREAM;TOPICAL	073548-001	Jun 30, 1992	AB	RX	No	No
Galderma Labs Lp	DESOWEN	desonide	OINTMENT;TOPICAL	071425-001	Jun 15, 1988		DISCN	No	No
Almirall	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006		DISCN	Yes	No	8,962,000		Y
Alembic	DESONIDE	desonide	LOTION;TOPICAL	213632-001	Aug 24, 2020	AB	RX	No	Yes

Expired US Patents for DESONIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006	6,730,288
Leo Pharma As	DESONATE	desonide	GEL;TOPICAL	021844-001	Oct 20, 2006	6,387,383
Almirall	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006	9,492,384
Almirall	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006	8,962,000
Almirall	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006	7,029,659

International Patents for DESONIDE

Country	Patent Number	Title	Estimated Expiration
South Korea	20070069155	MICROEMULSION AND SUB-MICRON EMULSION PROCESS AND COMPOSITIONS
Australia	2005279704	Microemulsion & sub-micron emulsion process & compositions
Taiwan	200624124	Micro emulsion and sub-micron emulsion process and composition
China	101048136	Microemulsion and sub-micron emulsion process and compositions
Russian Federation	2381023	СПОСОБ ПОЛУЧЕНИЯ МИКРОЭМУЛЬСИЙ И СУБМИКРОННЫХ ЭМУЛЬСИЙ И КОМПОЗИЦИИ НА ИХ ОСНОВЕ (METHOD FOR MAKING MICROEMULSIONS AND SUBMICRON EMULSIONS AND BASED COMPOSITION)
Taiwan	I397427
South Africa	200702702	Microemulsion & sub-micron emulsion process & compositions

Supplementary Protection Certificates for DESONIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	21C1020	France		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024	LUC00208	Luxembourg		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210
2435024	301102	Netherlands		PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210
0613371	SPC/GB02/033	United Kingdom		PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
2435024	2021C/518	Belgium		PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
2435024	SPC/GB21/029	United Kingdom		PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210
2435024	2190014-7	Sweden		PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210

Market Dynamics and Financial Trajectory for DESONIDE: An In-depth Analysis

Last updated: July 27, 2025

Introduction

Desonide, a potent topical corticosteroid, serves primarily in the treatment of localized inflammatory skin conditions such as eczema, dermatitis, and psoriasis. Approved by regulatory agencies like the FDA, Desonide's broad utility, safety profile, and market presence position it as a staple in dermatological therapeutics. This analysis explores the current market dynamics, competitive landscape, regulatory environment, and projected financial trajectory of Desonide within the pharmaceutical sector.

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Pharmaceutical Profile and Therapeutic Indications

Desonide is classified as a low-potency corticosteroid, manifesting anti-inflammatory, antipruritic, and vasoconstrictive properties [1]. Its formulations—creams, ointments, and lotions—are typically prescribed for mild to moderate inflammatory skin conditions across pediatric and adult populations. The drug's safety profile, characterized by minimal systemic absorption, supports prolonged topical use, fostering consistent prescription volumes.

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Market Size and Growth Trends

Globally, the dermatological segment commands a lucrative market, with corticosteroids representing a significant share due to the high prevalence of inflammatory skin disorders [2]. The Desonide market, a subset within this space, benefits from its positioning as a low-potency corticosteroid with favorable safety, facilitating widespread adoption.

Market valuation estimates: Industry reports project the global topical corticosteroids market to reach approximately USD 4.5 billion by 2028, growing at a CAGR of 4.2% from 2023 to 2028 [3]. While Desonide's exclusive market share constitutes a smaller fraction, its consistent demand ensures stable revenue streams.

Regional insights: North America dominates due to high awareness and advanced healthcare infrastructure, followed by Europe. Emerging markets in Asia-Pacific witness accelerated growth, driven by increased dermatological health awareness and economic expansion.

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Market Drivers

1. Prevalence of Skin Conditions: Rising incidences of eczema, psoriasis, and dermatitis—exacerbated by urbanization and environmental factors—amplify demand for corticosteroids like Desonide [4].

2. Product Safety and Tolerability: The low side-effect profile of Desonide encourages its use over higher-potency steroids, especially in pediatric populations, fostering long-term prescribing patterns [1].

3. Advances in Formulation Technologies: Enhanced delivery systems—such as liposomal and hydrogel formulations—improve skin penetration and patient compliance, expanding market potential.

4. Expanding Prescriber Base: Dermatologists, pediatricians, and general practitioners increasingly favor Desonide for mild to moderate skin conditions, broadening sales channels.

Market Restraints

1. Generic Competition: The expiration of patent protections has led to numerous generic formulations, pressuring prices and margins [5].

2. Regulatory Challenges: Variability in regulatory approval processes and reimbursement policies across regions may hinder market expansion.

3. Concerns Over Long-term Use: Despite safety, apprehensions around corticosteroid side effects limit aggressive promotion and long-term usage.

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Competitive Landscape

Major pharmaceutical companies producing Desonide include:

• Bausch Health (a subsidiary of Valeant Pharmaceuticals): Market leader with Reczema®, a favored brand.
• GlaxoSmithKline and Mylan: Competitors offering generic versions.
• Innovator Brands: Some regional players develop specialized formulations targeting niche markets.

The landscape is characterized by intense price competition, with significant emphasis on formulation innovation and supply chain efficiency to maintain profitability.

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Regulatory Environment

Desonide’s approval status across key markets influences market dynamics:

• United States: Approved under the FDA’s dermatological indications; monographed as a OTC and prescription medication.
• European Union: Registered with the EMA; both prescription and OTC formulations available in certain countries.
• Emerging Markets: Regulatory pathways vary; some countries require localized clinical data, affecting market entry strategies.

Regulatory shifts toward stricter corticosteroid use guidelines could impact sales volumes, necessitating strategic compliance and advocacy initiatives.

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Financial Trajectory and Revenue Forecasts

Historical financials: While specific sales data for Desonide are proprietary, industry estimates suggest that topical corticosteroid segment revenue experienced annual growth of approximately 3.5% over the past five years, supported predominantly by Desonide’s stability in developed markets [2].

Forecast models: Projected CAGR of ~4% over the next five years indicates moderate expansion driven by regional growth, innovation, and wholeyears of patent expiration effects. Slight downward pressure on per-unit prices due to generic competition is anticipated, but volume growth should offset revenue declines to sustain overall revenue stability.

Key factors influencing trajectory:

• Genericization Impact: As patents expire, generic proliferation could slash unit prices by 20-30%, impacting profit margins.
• Market Expansion: Entry into underserviced emerging markets could catalyze growth, offsetting declines elsewhere.
• Formulation Innovations: Extended-release or combined formulations might command premium pricing and diversify revenue streams.

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Emerging Trends and Innovation Opportunities

• Novel Delivery Platforms: Nanotechnology-based formulations are in development to enhance bioavailability and reduce application frequency.
• Digital and Telehealth Integration: Teledermatology accelerates prescription trends, potentially increasing Desonide utilization through remote consultations.
• Personalized Medicine: Genomic and microbiome insights may tailor corticosteroid therapy, optimizing efficacy and safety.

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Conclusion

Desonide’s market remains driven by its safety profile, therapeutic efficacy, and widespread dermatological need. While patent protections have largely expired, intensifying generic competition constrains margins. Nonetheless, regional growth, formulation innovation, and healthcare delivery advances promise steady financial performance over the coming years. Stakeholders must adapt to evolving regulatory standards, optimize supply chains, and innovate formulations to sustain competitive advantage.

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Key Takeaways

• The Desonide market benefits from a consistent demand for low-potency corticosteroids in dermatology, with stable revenue projections around 4% CAGR through 2028.
• Regional growth in emerging markets offers new revenue streams, offsetting price erosion due to generic competition.
• Innovation in formulation and digital health integration present opportunities for differentiation and premium pricing.
• Regulatory landscapes vary significantly, requiring strategic compliance to maintain market access.
• Price competition and patent expirations necessitate a focus on operational efficiency and product differentiation for profit sustainability.

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FAQs

1. What factors influence the pricing of Desonide formulations?
Pricing is impacted by patent status, generic competition, formulation complexity, regional regulatory standards, and market demand. Patent expirations generally lead to price reductions due to increased generic availability.

2. How does regional regulation affect Desonide market entry?
Regions with stringent approval processes and different classification (OTC vs. prescription) influence product access, pricing strategies, and marketing approaches. Local clinical data requirements can delay or complicate market entry.

3. What are the primary therapeutic advantages of Desonide over higher-potency corticosteroids?
Desonide offers effective anti-inflammatory action with a lower risk of side effects such as skin atrophy, making it suitable for sensitive populations and prolonged use.

4. How is innovation impacting Desonide’s market positioning?
Formulation advancements, like sustained-release topical systems, enhance efficacy, improve patient adherence, and allow premium pricing. Digital health integrations expand reach through telemedicine channels.

5. What measures can manufacturers adopt to sustain profitability amid rising generic competition?
Investing in formulation innovation, expanding into emerging markets, engaging in brand differentiation, optimizing supply chains, and leveraging digital platforms can help sustain margins.

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References

[1] U.S. Food and Drug Administration (FDA). Desonide topical data sheet. 2022.
[2] MarketWatch. Topical corticosteroids market report. 2022.
[3] Research and Markets. Global topical corticosteroids market forecast. 2023.
[4] WHO. Prevalence of dermatological conditions. 2021.
[5] Pharmaceutical Technology. Patent expiration and generic competition. 2022.