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	6,387,383

International Patents for DESONATE

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

Country	Patent Number	Title	Estimated Expiration
Poland	213237
South Korea	20030057526
Poland	360589

Supplementary Protection Certificates for DESONATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	132021000000095	Italy		PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
1304992	PA2013025,C1304992	Lithuania		PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323

Market Dynamics and Financial Trajectory for Desonate

Last updated: July 29, 2025

Introduction

Desonate (desonide ophthalmic suspension or gel) emerges as a notable corticosteroid treatment designated for managing ocular inflammatory conditions. As with many niche pharmaceuticals, its market landscape is shaped by factors including clinical demand, regulatory environment, patent status, competitive dynamics, and emerging therapeutic alternatives. This analysis delineates the current market structure, anticipated growth trajectory, and strategic insights into Desonate’s financial prospects.

Pharmacological Profile and Therapeutic Indications

Desonate, a low-potency corticosteroid, is primarily indicated for allergic conjunctivitis, anterior uveitis, and ocular inflammation following surgery or trauma. Its favorable safety profile, owing to minimal systemic absorption, makes it a first-line topical treatment in ophthalmology. The drug’s targeting of inflammation with reduced adverse effects relative to higher-potency counterparts positions it as a preferred option, especially in delicate patient populations.

Market Landscape and Key Drivers

1. Growing Prevalence of Ocular Inflammatory Diseases

The expanding base of patients suffering from ocular inflammation plays a pivotal role in market expansion. Rising incidences are attributed to aging populations, increased screening protocols, and higher prevalence of allergic conjunctivitis, especially in urbanized regions with environmental pollutants. The Global Ocular Inflammation Market was valued at approximately USD 1.1 billion in 2022, with projections indicating a CAGR of around 4.2% through 2030 [1].

2. Advancements in Ophthalmic Drug Technologies

Development of formulations that improve drug bioavailability, reduce dosing frequency, and enhance patient adherence critically influences Desonate’s market share. The ophthalmic drug delivery sector is witnessing innovation in sustained-release and minimally invasive delivery systems, implicitly pressuring traditional corticosteroid offerings.

3. Regulatory and Reimbursement Dynamics

Approval pathways for ophthalmic steroids are well-established, with Desonate already cleared in the U.S. and Europe. Reimbursement frameworks in these territories favor drugs with proven safety profiles and cost-effective management options, supporting sustained market penetration. However, pricing pressures due to competitive generics and biosimilars could influence revenue streams.

4. Competitive Landscape

Generic corticosteroids, such as prednisolone acetate and dexamethasone formulations, dominate the market due to lower cost. The key differentiator for Desonate hinges on its safety profile, dosing regimen, and clinician preference. Major players include Alcon, Allergan (AbbVie), and pharmaceutical companies developing newer anti-inflammatory agents, including biologics.

5. Impact of Biologic and Nonsteroidal Alternatives

Emerging biologics and non-steroidal anti-inflammatory drugs (NSAIDs) targeting ocular inflammation threaten to erode market share, especially as these agents demonstrate comparable efficacy with fewer side effects. The introduction of these therapies could cap the growth potential of traditional corticosteroids like Desonate in certain applications.

Financial Trajectory and Market Forecasts

1. Revenue Projections

Although precise sales data for Desonate are proprietary, industry estimates suggest that the ophthalmic corticosteroid segment, including Desonate, grew modestly at about 3–5% CAGR over the past five years. Based on market analyses [2], Desonate’s sales are projected to reach USD 150–200 million globally within the next five years, contingent on regulatory approval expansion, physician adoption, and formulary inclusion.

2. Pricing and Reimbursement Trends

Pricing strategies will significantly influence revenue. As patents age and generics flood the market, prices are expected to decline, exerting downward pressure on margins. Contractual discounts, rebates, and tiered reimbursement models could further impact net revenues.

3. Patent and Regulatory Outlook

Desonate’s patent exclusivity benefits are expected to expire by 2025–2027, after which significant generic competition will likely suppress prices and market share. Conversely, securing additional formulations, combination therapies, or indications could extend its financial lifespan, provided new patents or regulatory protections are granted.

4. Strategic Opportunities and Risks

Investment in targeted clinical trials to expand indications (e.g., dry eye, other inflammatory pathologies) could open new revenue streams. However, risks include rapid market entry by biosimilars, regulatory delays, and unfavorable reimbursement policies.

Market Entry and Expansion Strategies

• Clinical Differentiation: Highlighting safety and tolerability in prescriber education.
• Formulation Innovation: Developing sustained-release or combination drugs.
• Geographic Expansion: Prioritizing emerging markets with increasing ophthalmic disease burdens.
• Partnerships: Collaborating with global distributors and ophthalmology networks.

Conclusion

Desonate is poised at a juncture where its relatively established safety profile and targeted indications can foster steady growth. Nonetheless, intensifying generic competition, evolving treatment paradigms, and patent expirations present significant hurdles. Strategic adaptation—through formulation enhancements, indication expansion, and geographic penetration—will be instrumental in optimizing its financial trajectory over the coming decade.

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Key Takeaways

• Desonate occupies a niche in ophthalmic corticosteroids with favorable safety, positioning it for continued moderate growth.
• The expanding global burden of ocular inflammatory conditions supports demand, but competition from generics and novel therapies constrains upside potential.
• Patent expirations around 2025–2027 threaten revenue streams; strategic innovation and indication expansion are vital.
• Price reductions due to generics will likely pressure margins; partnerships and formulation advancements offer mitigative pathways.
• A balanced approach focusing on clinical differentiation and geographic expansion can sustain Desonate’s market relevance.

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FAQs

1. When will Desonate face patent expiry, and how will it impact the market?
Patent protection for Desonate is expected to expire between 2025 and 2027, after which generic competitors could significantly reduce its market share and revenue.

2. How does Desonate compare against competing corticosteroids in terms of safety?
Desonate’s low potency and minimal systemic absorption confer a superior safety profile, especially in long-term or repeated use scenarios, making it preferable over higher-potency corticosteroids in sensitive patients.

3. What are the primary factors influencing Desonate’s market growth?
Key drivers include rising prevalence of ocular inflammation, clinician preference for safety profiles, regulatory approval status, and competitive landscape shifts, including biosimilar entry.

4. Are there any recent regulatory changes affecting Desonate’s market?
While no recent regulatory amendments directly impact Desonate, evolving guidelines favoring safer, lower-risk ophthalmic corticosteroids bolster its clinical utility.

5. What strategic moves can pharmaceutical companies undertake to extend Desonate’s financial lifespan?
Innovations in formulation, expanding indications beyond inflammation, pursuing new geographic markets, and establishing strategic alliances can prolong its market viability.

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Sources:
[1] MarketsandMarkets, “Ocular Inflammation Market,” 2022.
[2] IQVIA, Pharmaceutical Market Reports, 2022.