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Last Updated: March 16, 2025

Desonide - Generic Drug Details


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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, Taro, Galderma Labs Lp, Leo Pharma As, Cintex Svcs, Fougera Pharms, Pai Holdings Pharm, 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. Seventeen suppliers are listed for this compound.

Drug Prices for desonide

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Drug Sales Revenue Trends for desonide

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Recent Clinical Trials for desonide

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

SponsorPhase
Procter and GamblePhase 3
EMSPhase 4
Massachusetts General HospitalPhase 3

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Pharmacology for desonide
Medical Subject Heading (MeSH) Categories for desonide
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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Galderma Labs Lp DESOWEN desonide OINTMENT;TOPICAL 071425-001 Jun 15, 1988 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Cosette DESONIDE desonide CREAM;TOPICAL 074027-001 Sep 28, 1992 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Encube Ethicals DESONIDE desonide OINTMENT;TOPICAL 210998-001 Jan 30, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Alembic DESONIDE desonide OINTMENT;TOPICAL 212473-001 Oct 23, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Expired US Patents for desonide

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Leo Pharma As DESONATE desonide GEL;TOPICAL 021844-001 Oct 20, 2006 ⤷  Try for Free ⤷  Try for Free
Almirall VERDESO desonide AEROSOL, FOAM;TOPICAL 021978-001 Sep 19, 2006 ⤷  Try for Free ⤷  Try for Free
Almirall VERDESO desonide AEROSOL, FOAM;TOPICAL 021978-001 Sep 19, 2006 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 3 of 3 entries

International Patents for desonide

CountryPatent NumberTitleEstimated Expiration
Japan 2008511550 ⤷  Try for Free
Russian Federation 2381023 СПОСОБ ПОЛУЧЕНИЯ МИКРОЭМУЛЬСИЙ И СУБМИКРОННЫХ ЭМУЛЬСИЙ И КОМПОЗИЦИИ НА ИХ ОСНОВЕ (METHOD FOR MAKING MICROEMULSIONS AND SUBMICRON EMULSIONS AND BASED COMPOSITION) ⤷  Try for Free
South Africa 200702702 Microemulsion & sub-micron emulsion process & compositions ⤷  Try for Free
World Intellectual Property Organization (WIPO) 2006024095 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 4 of 4 entries

Supplementary Protection Certificates for desonide

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
2435024 132021000000095 Italy ⤷  Try for Free 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
2435024 2190014-7 Sweden ⤷  Try for Free 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 ⤷  Try for Free 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 ⤷  Try for Free 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
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory of Desonide

Introduction

Desonide, a topical corticosteroid, has been a staple in the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses since its approval in 1972. Here, we delve into the market dynamics and financial trajectory of Desonide, highlighting its impact, challenges, and the strategies employed by its originator, Perrigo Co. Plc.

Market Approval and Recognition

Desonide has received widespread approval globally, indicating its significant recognition and use in the pharmaceutical market. First approved in the United States in January 1972, Desonide has been used to treat various medical conditions, including dermatitis, atopic dermatitis, and pruritus[1][4].

Therapeutic Areas and Versatility

Desonide's therapeutic versatility is a key factor in its market success. It targets the glucocorticoid receptor (GR), modulating the immune response and treating immune system diseases, congenital disorders, and skin and musculoskeletal diseases. This broad range of indications has contributed to its enduring presence in the market[1].

Originator and Intellectual Property

Perrigo Co. Plc, the originator of Desonide, holds the intellectual property rights and has been responsible for its initial development and commercialization. Perrigo's expertise in developing and manufacturing a wide range of healthcare products has been instrumental in Desonide's success[1].

Market Performance and Sales

Perrigo's financial reports reflect the steady performance of Desonide within their product portfolio. For instance, in fiscal 2014, Perrigo achieved a 15% increase in sales, driven by a mix of organic growth, sales from acquired products, and new product launches. This growth was part of an eight-year streak of increasing revenue, operating cash flow, and adjusted operating margin[2].

Organic and Inorganic Growth

Perrigo's business strategy has balanced organic and inorganic growth. From 2008 to 2014, the company achieved a net sales compound annual growth rate of 16%, with 8% from organic sales and 8% from inorganic sales. This balanced approach has helped maintain Desonide's market presence alongside other products[2].

Competitive Landscape

The generic drug market, including Desonide, has faced significant competition due to the FDA's accelerated approvals of new generics. This led to a surge in new competitors and downward pricing pressure. Perrigo, aware of these market dynamics, closely tracked competitors and adjusted its strategies accordingly[5].

Impact of Generic Competition

The influx of new generic drugs has resulted in never-before-seen levels of competition, affecting pricing and market share. Despite this, Perrigo has managed to maintain its position through strategic acquisitions, new product launches, and geographic expansion[5].

Financial Highlights

Perrigo's financial performance over the years reflects the resilience of Desonide in the market. Here are some key financial highlights:

  • Net Sales Growth: In fiscal 2014, Perrigo reported a 15% increase in net sales, reaching $4.060 billion[2].
  • Adjusted Operating Income: The company saw a 28% increase in adjusted operating income to $1.029 billion in fiscal 2014[2].
  • Research and Development: Perrigo has consistently increased investments in R&D, such as a 5% increase in 2018 to enhance its new product pipeline and address supply constraints[3].

Strategic Expansions and Investments

Perrigo has expanded its growth strategy through various means:

  • Licensing Deals: For example, the company secured a licensing deal for the non-prescription Nasonex® Nasal Spray in 2018[3].
  • New Product Launches: Over 90 new products were launched in 2018, generating approximately $170 million in net sales[3].
  • Geographic Expansion: Perrigo has expanded its presence in key markets worldwide, including Canada, China, Latin America, Israel, and Australia[2].

Challenges and Adaptations

Despite the challenges posed by generic competition, Perrigo has adapted by focusing on:

  • Value Brands: Enhancing its position in value brands, as seen in the acquisition of OTC products in Australia and New Zealand[2].
  • Supply Chain Efficiencies: Improving supply chain efficiencies and addressing supply constraints through increased investments[3].

Future Outlook

Perrigo's future growth strategy includes:

  • Organic Top-Line Revenue Growth: Aiming for a 5-10% increase in organic top-line revenue[2].
  • Operating Income Leverage: Targeting a 10-20% increase in operating income through disciplined M&A and operational efficiencies[2].
  • Adjacent Categories: Expanding into adjacent categories such as adult nutrition, ophthalmics, pet care, and diabetes care[2].

Key Takeaways

  • Desonide has maintained a strong market presence since its approval in 1972.
  • Perrigo's balanced growth strategy has helped navigate competitive market dynamics.
  • Continuous investments in R&D and strategic expansions have been crucial for Desonide's financial trajectory.
  • The company's ability to adapt to generic competition has ensured its enduring success.

FAQs

What is Desonide used for?

Desonide is used for the symptomatic treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, including dermatitis, atopic dermatitis, and pruritus[1][4].

Who is the originator of Desonide?

Perrigo Co. Plc is the originator of Desonide and holds the intellectual property rights for the drug[1].

How has Desonide performed in the market?

Despite facing significant generic competition, Desonide has maintained its market presence through Perrigo's strategic growth initiatives and continuous R&D investments[2][5].

What are the key financial highlights for Perrigo related to Desonide?

Perrigo has reported significant net sales growth, adjusted operating income increases, and consistent R&D investments, reflecting the drug's stable financial trajectory[2][3].

How has Perrigo adapted to market challenges?

Perrigo has adapted by focusing on value brands, improving supply chain efficiencies, and expanding into adjacent categories to maintain market competitiveness[2][3].

Sources

  1. Synapse by Patsnap: Desonide: Detailed Review of its Transformative R&D Success Mechanism of Action.
  2. Annual Reports: Leveraging the Perrigo - Annual Reports.
  3. Perrigo Annual Report: 2018 Annual Report for Web.
  4. DrugBank: Desonide: Uses, Interactions, Mechanism of Action.
  5. Kessler Topaz Meltzer & Check, LLP: Principal v. Perrigo - Complaint.

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