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, 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.

Summary for desonide

International Patents:	22
US Patents:	3
Tradenames:	4
Applicants:	15
NDAs:	25
Drug Master File Entries:	31
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	8
Patent Applications:	6,117
Drug Prices:	Drug price trends for desonide
Drug Sales Revenues:	Drug sales revenues 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
Procter and Gamble	Phase 3
EMS	Phase 4
NeoStrata Company, Inc.	Phase 3

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
Glenmark Speclt	DESONIDE	desonide	LOTION;TOPICAL	209494-001	Sep 26, 2017	AB	RX	No	No
Fougera Pharms	DESONIDE	desonide	LOTION;TOPICAL	075860-001	Mar 19, 2002	AB	RX	No	No
Alembic	DESONIDE	desonide	CREAM;TOPICAL	214396-001	Dec 8, 2022	AB	RX	No	No
Fougera Pharms	DESONIDE	desonide	OINTMENT;TOPICAL	075751-001	Mar 12, 2001	AB	RX	No	No
Alembic	DESONIDE	desonide	LOTION;TOPICAL	213632-001	Aug 24, 2020	AB	RX	No	No
Taro	DESONIDE	desonide	OINTMENT;TOPICAL	074254-001	Aug 3, 1994	AB	RX	No	No
Galderma Labs Lp	DESOWEN	desonide	LOTION;TOPICAL	072354-001	Jan 24, 1992	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	7,029,659

International Patents for desonide

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2438910	Procédé et compositions de micro-émulsion et d'émulsion submicronique (Microemulsion & sub-micron emulsion process & compositions)
Brazil	PI0514806	composições e processo de microemulsão e emulsão sub-mìcron
Japan	4972553
Russian Federation	2007111706	СПОСОБ ПОЛУЧЕНИЯ МИКРОЭМУЛЬСИЙ И СУБМИКРОННЫХ ЭМУЛЬСИЙ И КОМПОЗИЦИИ НА ИХ ОСНОВЕ
Hong Kong	1110198	MICROEMULSION & SUB-MICRON EMULSION PROCESS & COMPOSITIONS
Canada	2578594	PROCEDE ET COMPOSITIONS A BASE DE MICROEMULSION & EMULSION SUBMICRONIQUE (MICROEMULSION & SUB-MICRON EMULSION PROCESS & COMPOSITIONS)
Argentina	051197	UN PROCEDIMIENTO PARA OBTENER UNA MICROEMULSION Y SUB-MICRON EMULSION Y COMPOSICIONES

Supplementary Protection Certificates for desonide

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	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
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	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	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
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	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

Desonide Market Analysis and Financial Projection Experimental

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.