VERDESO Drug Patent Profile

When do Verdeso patents expire, and when can generic versions of Verdeso launch?

Verdeso is a drug marketed by Almirall and is included in one NDA. There are three patents protecting this drug.

This drug has twenty-two patent family members in sixteen countries.

The generic ingredient in VERDESO 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 Verdeso

A generic version of VERDESO was approved as desonide by TARO on August 3^rd, 1994.

Summary for VERDESO

International Patents:	22
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	60
Patent Applications:	4,822
Drug Prices:	Drug price information for VERDESO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VERDESO
What excipients (inactive ingredients) are in VERDESO?	VERDESO excipients list
DailyMed Link:	VERDESO at DailyMed

See drug prices for VERDESO

US Patents and Regulatory Information for VERDESO

VERDESO is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006		DISCN	Yes	No	9,492,384		Y
Almirall	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006		DISCN	Yes	No	8,460,641		Y
Almirall	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006		DISCN	Yes	No	8,962,000		Y

Expired US Patents for VERDESO

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
Almirall	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006	7,029,659

International Patents for VERDESO

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2007111706	СПОСОБ ПОЛУЧЕНИЯ МИКРОЭМУЛЬСИЙ И СУБМИКРОННЫХ ЭМУЛЬСИЙ И КОМПОЗИЦИИ НА ИХ ОСНОВЕ
European Patent Office	2438910	Procédé et compositions de micro-émulsion et d'émulsion submicronique (Microemulsion & sub-micron emulsion process & compositions)
Poland	1796636

Supplementary Protection Certificates for VERDESO

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

VERDESO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VERDESO

Introduction to VERDESO

VERDESO (desonide) foam is a topical corticosteroid indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Here, we will delve into the market dynamics and financial trajectory associated with this medication.

Market Context: Atopic Dermatitis Treatment

The global atopic dermatitis (AD) treatment market is experiencing significant growth, driven by factors such as a large under-diagnosed patient pool, high prevalence among adults and children, and the development of new treatment options. The market is anticipated to reach $31.7 billion by 2031, growing at a CAGR of 14.1%[1].

Competitive Landscape

In the AD treatment market, VERDESO competes with other topical corticosteroids and newer biologic therapies. Key competitors include Pfizer’s Eucrisa (crisaborole) and Sanofi’s Dupixent (dupilumab), which have significantly altered market dynamics. While traditional treatments like Protopic (tacrolimus) and Elidel (pimecrolimus) are facing generic erosion, newer therapies are driving market growth[1].

Regional Market Performance

The North America region dominates the global AD treatment market due to a large target population, higher treatment awareness, swift adoption of novel medications, and better reimbursement policies. This region is likely to be a significant market for VERDESO, given its approval and usage in the U.S.[1].

Key Drivers and Challenges

• Increasing Incidence of Atopic Dermatitis: The rising incidence of AD, especially among children and adolescents, is a key driver for the demand of treatments like VERDESO.
• Technological Advancements: Improvements in drug formulations and delivery systems, such as the foam formulation of VERDESO, enhance patient compliance and efficacy.
• Regulatory Environment: Regulatory approvals and favorable reimbursement policies in regions like North America support the market growth of VERDESO.
• Generic Erosion and Patient Compliance: Despite these drivers, the market faces challenges such as generic erosion of older treatments and poor patient compliance in some countries, which can impact the overall growth trajectory[1][3].

Financial Performance and Projections

While specific financial data for VERDESO is not readily available, its performance can be inferred from the broader context of the AD treatment market and the financial health of its manufacturers.

• Revenue Growth: The AD treatment market's projected growth to $31.7 billion by 2031 indicates a favorable financial trajectory for treatments like VERDESO.
• Market Share: As a topical corticosteroid, VERDESO will likely maintain a significant market share, especially in the mild-to-moderate AD segment, which accounts for a substantial portion of the market[1].

Manufacturer's Financial Health

Companies involved in the dermatology sector, such as those manufacturing VERDESO, often report strong financial performance driven by their dermatology portfolios. For example, Almirall, a company focused on dermatology, reported a 13.5% increase in net sales in 2014, driven by their dermatology products, and demonstrated strong financial health through successful bond issuances and strategic acquisitions[5].

R&D and Innovation

The continuous investment in research and development (R&D) by pharmaceutical companies is crucial for maintaining market position. The development of new treatments and the improvement of existing ones, such as the foam formulation of VERDESO, are key to staying competitive in the market. Companies like Almirall and others in the dermatology sector prioritize R&D to ensure long-term growth and sustainability[2][5].

Regulatory and Safety Considerations

VERDESO, like other topical corticosteroids, must navigate regulatory requirements and safety concerns. The drug has been shown to reversibly suppress the hypothalamic-pituitary-adrenal (HPA) axis, which can lead to systemic effects. Regulatory oversight and periodic evaluations for HPA axis suppression are essential for its continued use and market acceptance[4].

Key Takeaways

• Growing Market: The AD treatment market is expanding rapidly, driven by new therapies and increasing incidence.
• Competitive Landscape: VERDESO competes with both traditional and newer treatments, with a focus on mild-to-moderate AD cases.
• Regional Strength: North America is a key market due to favorable reimbursement policies and high treatment awareness.
• Financial Health: The financial trajectory for VERDESO is positive, supported by the overall growth of the AD treatment market and the financial health of its manufacturers.
• Regulatory and Safety Focus: Continuous monitoring of safety and regulatory compliance is crucial for maintaining market position.

FAQs

1. What is VERDESO used for?

   • VERDESO (desonide) foam is used for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older[4].

2. How does VERDESO compare to other AD treatments?

   • VERDESO competes with other topical corticosteroids and newer biologic therapies like Dupixent and Eucrisa. It is particularly effective for mild-to-moderate AD cases[1].

3. What are the potential side effects of VERDESO?

   • VERDESO can cause systemic absorption and effects including HPA axis suppression, manifestations of Cushing’s syndrome, and other systemic effects. It is advised to use it for no more than 4 weeks to minimize these risks[4].

4. Which regions are key markets for VERDESO?

   • North America is a dominant market for VERDESO due to a large target population and favorable reimbursement policies[1].

5. How does the financial health of manufacturers impact VERDESO's market performance?

   • The financial health of manufacturers, such as strong revenue growth and R&D investments, supports the market performance of VERDESO by ensuring continuous innovation and market presence[2][5].

Cited Sources

1. Global Atopic Dermatitis Treatment Market: iHealthcareAnalyst
2. Annual Report 2018: Annual Reports
3. Topical Drug Delivery Market: Verified Market Research
4. VERDESO Prescribing Information: Drugs.com
5. Annual Report 2014: Annual Reports