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. Seventeen 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 TARO on August 3^rd, 1994.

Summary for DESONATE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	1
Patent Applications:	4,720
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
Canada	2417646	SYSTEME DE DISTRIBUTION D'UN GEL TOPIQUE (TOPICAL GEL DELIVERY SYSTEM)
Luxembourg	92401
Poland	213237
South Africa	200301037	Topical gel delivery system.

Supplementary Protection Certificates for DESONATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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
1304992	CR 2013 00053	Denmark		PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322

Market Dynamics and Financial Trajectory for Desonate (Desonide)

Introduction to Desonate

Desonate, a brand name for the topical corticosteroid desonide, is widely used for the treatment of various skin conditions, including eczema, psoriasis, and allergic dermatitis. Understanding the market dynamics and financial trajectory of Desonate is crucial for stakeholders in the pharmaceutical industry.

Market Overview

The global market for desonide, including its API (Active Pharmaceutical Ingredient) and formulated products like Desonate, is experiencing significant growth. Here are some key points:

Market Size and Growth

The Desonide API market is projected to see strong growth rates from 2023 to 2031, driven by increasing demand for topical corticosteroids. The market size is expected to expand substantially, with projections indicating a notable increase in revenue across various segments, including aerosol, capsule, suspension, tablet, and powder formulations[3].

Geographical Segmentation

The market is segmented geographically into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region is expected to contribute to the overall growth, with Asia-Pacific likely to be a significant driver due to its large population and growing healthcare needs[3].

Market Dynamics

Drivers

• Increasing Prevalence of Skin Conditions: The rising incidence of skin diseases such as eczema, psoriasis, and allergic dermatitis is a major driver for the desonide market.
• Advancements in Formulations: Innovations in delivery systems, such as gels, creams, and ointments, enhance patient compliance and efficacy, driving market growth.
• Expanding Healthcare Infrastructure: Improvements in healthcare infrastructure, especially in emerging markets, increase access to treatments like Desonate[3].

Restraints

• Regulatory Challenges: Strict regulatory environments can slow down the approval and launch of new formulations.
• Generic Competition: The availability of generic versions of desonide can reduce the market share of branded products like Desonate[4].
• Safety Concerns: Potential side effects and safety concerns associated with long-term use of topical corticosteroids can impact market growth.

Opportunities

• Emerging Markets: Expanding into new geographical markets, particularly in Asia-Pacific and Latin America, offers significant growth opportunities.
• Innovative Delivery Systems: Developing new delivery systems that improve efficacy and patient compliance can open up new market segments.
• Dermatology Research: Advances in dermatology research could lead to new indications for desonide, further expanding its market[3].

Challenges

• Counterfeit Medications: The risk of counterfeit medications, especially when purchased online, poses a challenge to the legitimate market for Desonate[4].
• Economic Factors: Economic downturns can affect healthcare spending and impact the demand for non-essential treatments.

Financial Trajectory

Historical Performance

In the past, companies involved in the production and distribution of desonide have shown significant financial growth. For example, Perrigo Company plc, a major player in the consumer healthcare and pharmaceuticals sector, reported a 15% increase in sales in fiscal 2014, driven by organic growth and acquisitions. This growth included contributions from their dermatology and topical products segment[2].

Future Projections

The financial trajectory for Desonate and related products is expected to be positive. The Desonide API market is forecasted to experience strong growth rates, with the market size expected to increase substantially from 2023 to 2031. This growth will be driven by increasing demand, new formulations, and expansion into emerging markets[3].

Key Players and Strategies

LEO Pharma

LEO Pharma, the manufacturer of Desonate, has been actively involved in dermatology research and development. The company has made significant investments in R&D, including a $70 million equity financing and R&D support deal for a global phase 3 trial of a dermatology treatment[5].

Perrigo Company plc

Perrigo, another major player, has a strong focus on organic growth and strategic acquisitions. Their vision to be a leader in providing quality, affordable healthcare products aligns with the growing demand for desonide and other topical corticosteroids[2].

Competitive Landscape

The competitive landscape for Desonate includes both branded and generic versions of desonide. The market is highly competitive, with several manufacturers offering various formulations. The discontinuation of certain formulations, such as the 0.05% gel version of Desonate, can impact market dynamics and create opportunities for other products[4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Desonate. FDA approvals and compliance with regulatory standards are essential for the launch and continued sale of these products. The FDA's approval of Desonate in various formulations and the monitoring of generic versions ensure that only safe and effective products reach the market[4].

Consumer and Healthcare Provider Perspectives

Patient Compliance

Patient compliance is a critical factor in the success of Desonate. Innovations in formulations that make the product easier to use and more effective can significantly improve patient outcomes and drive market growth.

Healthcare Provider Recommendations

Healthcare providers play a vital role in recommending Desonate and other desonide products. Their confidence in the efficacy and safety of these products is crucial for maintaining market share.

Technological Advancements

Technological advancements in drug delivery systems and formulation development are expected to enhance the market for Desonate. New technologies that improve the bioavailability and stability of desonide can lead to better treatment outcomes and increased market demand.

Global Expansion

Global expansion is a key strategy for companies involved in the desonide market. Entering new markets, especially in regions with growing healthcare needs, can significantly boost sales and revenue.

Key Takeaways

• The Desonide API market is projected to experience strong growth from 2023 to 2031.
• Increasing prevalence of skin conditions and advancements in formulations are major drivers.
• Regulatory challenges, generic competition, and safety concerns are significant restraints.
• Emerging markets and innovative delivery systems offer substantial growth opportunities.
• Key players like LEO Pharma and Perrigo Company plc are focusing on R&D and strategic acquisitions to maintain market leadership.

FAQs

What is Desonate used for?

Desonate is used for the treatment of various skin conditions, including eczema, psoriasis, and allergic dermatitis.

Who manufactures Desonate?

Desonate is manufactured by LEO Pharma.

What are the key drivers of the Desonide API market?

The key drivers include the increasing prevalence of skin conditions, advancements in formulations, and expanding healthcare infrastructure.

What are the main restraints on the Desonide API market?

The main restraints include regulatory challenges, generic competition, and safety concerns associated with long-term use.

What are the future projections for the Desonide API market?

The market is expected to experience strong growth rates from 2023 to 2031, driven by increasing demand and new formulations.

Sources

1. Market Research Reports: Desonide - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030.
2. Annual Reports: Perrigo - Annual Reports.
3. Market Research Intellect: Global Desonide API Market Size, Scope And Forecast Report.
4. Drugs.com: Generic Desonate Availability.
5. Fierce Biotech: GE Healthcare executive jumps ship to lead dermatology biotech LEO.