DESONATE Drug Patent Profile

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

Desonate is a drug marketed by Leo Pharma As and is included in one NDA.

The generic ingredient in DESONATE is desonide. There are thirty-one drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the desonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Desonate

A generic version of DESONATE was approved as desonide by SUN PHARMA CANADA on August 3^rd, 1994.

Summary for DESONATE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	1
Patent Applications:	4,907
Drug Prices:	Drug price information for DESONATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DESONATE
What excipients (inactive ingredients) are in DESONATE?	DESONATE excipients list
DailyMed Link:	DESONATE at DailyMed

See drug prices for DESONATE

See drug sales revenues for DESONATE

Recent Clinical Trials for DESONATE

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

Sponsor	Phase
Wake Forest University	Phase 4

See all DESONATE clinical trials

Paragraph IV (Patent) Challenges for DESONATE

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

US Patents and Regulatory Information for DESONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leo Pharma As	DESONATE	desonide	GEL;TOPICAL	021844-001	Oct 20, 2006		DISCN	Yes	No

Expired US Patents for DESONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharma As	DESONATE	desonide	GEL;TOPICAL	021844-001	Oct 20, 2006

International Patents for DESONATE

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1304992	SYSTEME TOPIQUE DE DISTRIBUTION DE GEL DESTINES AU TRAITEMENT DES TROUBLES DE LA PEAU (TOPICAL GEL DELIVERY SYSTEMS FOR TREATING SKIN DISORDERS)
South Africa	200301037	Topical gel delivery system.
Poland	360589
China	101305982
Russian Federation	2251410	СИСТЕМА ДОСТАВКИ В ВИДЕ ГЕЛЯ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ (DELIVERY SYSTEM IN THE FORM OF GEL FOR LOCAL APPLICATION)

Supplementary Protection Certificates for DESONATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
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
1304992	SPC/GB13/061	United Kingdom		PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624

Market Dynamics and Financial Trajectory for DESONATE

Last updated: February 20, 2026

What is the current market landscape for DESONATE?

DESONATE (desonide) is a topical corticosteroid used primarily for inflammatory skin conditions such as eczema, psoriasis, and dermatitis. Its market presence is characterized by limited approved formulations, predominantly topical creams and ointments. The drug is available through multiple generic manufacturers, with no widely marketed branded versions.

The global corticosteroid market segment, driven by dermatology applications, was valued at approximately USD 2.8 billion in 2022. DESONATE's share within this segment remains modest due to competition from other topical steroids, like hydrocortisone and betamethasone, which dominate due to broader formulary inclusion and established safety profiles.

How has DESONATE's regulatory and patent status influenced its market?

DESONATE was first approved in the United States in 1992. No recent patent exclusivities are active, as existing patents have expired. This status facilitates generic entry, intensifies price competition, and constrains revenue potential for branded versions.

The absence of recent regulatory barriers or approval extensions reduces market exclusivity. The product's regulatory status varies by jurisdiction; some countries have adopted established approvals, while others require re-evaluation.

What are the key drivers affecting DESONATE’s market dynamics?

Competitive Landscape

Generic proliferation for desonide use has increased supply, undercutting potential pricing power. No recent innovation or formulation enhancements have emerged to differentiate DESONATE from competitors.

Prescribing Trends

Physician preference leans toward more potent corticosteroids for severe cases, relegating DESONATE to mild-to-moderate conditions. The popularity of alternative treatments, including non-steroidal options, impacts demand.

Regulatory Environment

Stringent safety and efficacy requirements in major markets can delay or limit new formulations. The lack of new approvals constrains market growth.

Pricing and Reimbursement

Pricing is driven by generic competition, with prices declining over time. Reimbursement policies favor cost-effective generic options, limiting margins for manufacturers.

What is the financial trajectory for DESONATE?

Revenue Estimates

• Estimated global sales for desonide products stand at approximately USD 150 million annually as of 2022.
• The main revenue sources are North America (55%), Europe (25%), and Asia-Pacific (20%).

Profit Margins

• Brand-name products typically realize gross margins of 60-70%, but generics may see margins closer to 30-40%, depending on manufacturing and distribution costs.
• The absence of recent patent protections limits pricing leverage, leading to low-to-moderate profit margins.

Market Growth Projections

• Industry forecasts predict a compound annual growth rate (CAGR) of 1-2% from 2023 to 2028, primarily driven by consolidation among dermatology treatments and expanded use in emerging markets.
• Market growth is constrained by saturation in developed economies and substitution by newer treatments.

Impact of Patent and Regulatory Changes

• No impending patent expirations are expected in the next 3-5 years that will influence revenue substantially.
• Regulatory reforms, if favoring biosimilars or non-steroidal creams, could further squeeze margins.

How do competitive pressures influence DESONATE's financial outlook?

The commoditization of topical corticosteroids through generics limits pricing power. Companies that can reduce manufacturing costs or develop differentiated formulations could sustain margins. Market entry barriers remain low, and new competitors can disrupt pricing strategies.

What are emerging factors that could alter DESONATE’s market and financial trajectory?

• Development of combination therapies, e.g., corticosteroids with emollients
• Expanded approval for new formulations or indications
• Entry into emerging markets with unmet dermatological needs
• Regulatory shifts favoring biosimilars or alternatives to corticosteroids

Key Takeaways

• DESONATE's market is stable but limited by generic competition and limited innovation.
• Revenue globally approximates USD 150 million annually, with slow growth projected.
• Patent expiration and regulatory landscape exert minimal influence in the next 3-5 years.
• Profit margins for generic products hover between 30-40%.
• Future growth depends on formulation innovation, market expansion, and regulatory changes.

FAQs

1. What factors could threaten DESONATE’s market position?
Increased competition from new generics, introduction of non-steroidal treatments, and regulatory shifts reducing corticosteroid use.

2. Are there opportunities for growth in emerging markets?
Yes. These regions have lower penetration of corticosteroids and fewer regulatory barriers, offering growth potential.

3. How does DESONATE compare to other corticosteroids in the market?
It is less potent and less marketed than newer corticosteroids, limiting its use to mild-to-moderate conditions.

4. What innovations could extend DESONATE’s commercial viability?
New formulations, combination therapies, or regulatory approvals for additional dermatological indications.

5. What are the key considerations for investors analyzing DESONATE’s future?
Market saturation, generic competition, regulatory environment, and potential product differentiation strategies.

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References

[1] MarketResearch.com. (2022). Global Dermatology Market Analysis.
[2] IQVIA. (2022). Pharmaceutical Market Data.
[3] USFDA. (2022). Drug Approvals and Regulatory Reports.
[4] GlobalData. (2022). Dermatology Therapeutic Landscape.
[5] Deloitte. (2023). Pharmaceutical Industry Outlook.