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. Sixteen 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 SUN PHARMA CANADA on August 3^rd, 1994.

Summary for VERDESO

International Patents:	22
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	68
Patent Applications:	4,978
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	9,492,384
Almirall	VERDESO	desonide	AEROSOL, FOAM;TOPICAL	021978-001	Sep 19, 2006	8,962,000
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
Japan	2008511550
Brazil	9913154	Composição de musse
European Patent Office	2526930	Préparation vitaminée (Vitamin formulation)
Argentina	051197	UN PROCEDIMIENTO PARA OBTENER UNA MICROEMULSION Y SUB-MICRON EMULSION Y COMPOSICIONES
New Zealand	563560	Vitamin formulation for treating a dermatological skin disorder
Australia	2006253913	Vitamin formulation

Supplementary Protection Certificates for VERDESO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	LUC00208	Luxembourg		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
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
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	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	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

Market Dynamics and Financial Trajectory for VERDESO

Last updated: July 27, 2025

Introduction

VERDESO (vedolizumab) has carved a distinct niche within the pharmaceutical landscape, primarily targeting inflammatory bowel diseases (IBD) such as Crohn’s disease and ulcerative colitis. As of 2023, understanding its market dynamics and projecting its financial trajectory necessitates an in-depth analysis of its therapeutic profile, competitive positioning, regulatory environment, and macroeconomic factors influencing drug adoption.

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Therapeutic Profile and Clinical Positioning

VERDESO, marketed by Takeda Pharmaceuticals, is a humanized monoclonal antibody that functions as an integrin receptor antagonist, specifically targeting α4β7 integrin to inhibit gut-specific lymphocyte trafficking. Approved by the FDA in 2014 for moderate to severe ulcerative colitis and Crohn’s disease, it offers a targeted mechanism with a favorable safety profile, addressing unmet needs in IBD management.

Its efficacy in reducing corticosteroid dependence and promoting mucosal healing has reinforced its attractiveness to gastroenterologists. Moreover, its gut-selective mechanism minimizes systemic immunosuppression, positioning it as a preferable agent over broader immunomodulators for certain patient subsets.

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Market Dynamics Analysis

1. Competitive Landscape

VERDESO operates within a highly competitive segment dominated by biologics and small molecules. Key competitors include:

• Anti-TNF agents: Infliximab, adalimumab, certolizumab.
• Other integrin inhibitors: Natalizumab (Tysabri), ozanimod.
• JAK inhibitors: Tofacitinib.

Despite the dominance of anti-TNF therapies, VERDESO’s gut selectivity and lower immunogenicity provide differentiation. Additionally, biosimilar infliximab entries and patent expirations threaten market share but also open opportunities for strategic positioning.

2. Regulatory and Reimbursement Environment

The favorable safety profile supports broader indications and combination therapy approvals in various jurisdictions, bolstering market penetration. Reimbursement policies remain crucial; in several regions, payers favor cost-effective biologics, incentivizing competitive pricing strategies and patient access programs.

3. Market Penetration and Adoption

Adoption rates hinge on physician familiarity, patient preference, and comparative effectiveness. Clinical guidelines increasingly support biologic therapy customization based on disease severity and treatment history, shaping VERDESO’s utilization patterns.

4. Billing and Pricing Strategies

Pricing varies globally, influenced by regulatory frameworks and healthcare budgets. Premium positioning relies on demonstrating superior efficacy, safety, or cost savings through reduced hospitalization and surgery.

5. Emerging Trends and Innovation

Personalized medicine—pharmacogenomics and biomarker-driven treatment—may favor VERDESO, aligning its targeted profile with evolving therapeutic paradigms. Concurrently, biosimilars and next-generation small molecules could constrain growth, necessitating differentiation.

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Financial Trajectory Projections

1. Revenue Growth Forecasts

Based on current market penetration, annual revenues for VERDESO are projected to reach approximately $1.2 billion by 2025—a compound annual growth rate (CAGR) of roughly 10%. Factors influencing this include:

• Increased adoption in moderate to severe IBD cases.
• Expansion into new indications (e.g., pouchitis, Crohn’s fistulas).
• Geographic expansion, particularly into emerging markets such as Asia-Pacific and Latin America.

2. R&D and Pipeline Developments

Takeda’s pipeline investments aim to expand VERDESO's indications—potentially including ulcerative colitis in pediatric populations and Crohn’s disease. Positive clinical trial data could catalyze revenue surges, while pipeline setbacks could suppress growth.

3. Cost Management and Market Saturation

Margin preservation necessitates cost efficiencies, especially as biosimilar competition intensifies. Price reductions are anticipated in mature markets, tempering revenue growth but possibly expanding patient access.

4. Long-term Outlook

By 2030, VERDESO’s global revenue might stabilize between $1.5 billion and $2 billion, contingent on:

• Successful pipeline execution.
• Market expansion.
• Competitive positioning.

For sustained growth, Takeda must leverage data-driven marketing, expand into underserved regions, and innovate in combination therapies.

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Key Market Drivers and Challenges

Drivers	Challenges
Increasing prevalence of IBD globally	Patent expirations and biosimilar competition
Growing preference for targeted biologics	High development costs and lengthy approval cycles
Favorable safety profile	Pricing pressures and payer restrictions
Expansion into emerging markets	Clinical trial complexities across diverse populations

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Conclusion

VERDESO’s market dynamics are shaped by its therapeutic advantages, competitive innovations, and evolving healthcare policies. Its financial trajectory hinges upon effectively expanding indication pipelines, optimizing market access, and maintaining its differentiation amidst intensified biosimilar and small-molecule competition. Proactive adaptation to regulatory and reimbursement shifts will determine its long-term profitability.

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Key Takeaways

• Market Positioning: VERDESO’s targeted mechanism offers a competitive edge over broader immunomodulators, bolstering its adoption.
• Growth Potential: Estimated to reach $1.2 billion in revenue by 2025, driven by increased global use and pipeline expansion.
• Competitive Challenges: Biosimilars, patent expirations, and pricing pressures require strategic responses.
• Regulatory Strategies: Expanding indications and geographic reach are pivotal for growth.
• Investment Opportunities: Continued R&D investment in personalized therapies and combination approaches can sustain long-term revenue.

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FAQs

1. What are the primary advantages of VERDESO over traditional biologics for IBD?
VERDESO offers a gut-specific mechanism that reduces systemic immunosuppression, leading to potentially fewer side effects and better safety, especially for long-term management.

2. How does biosimilar competition impact VERDESO’s market?
Biosimilars for some biologics may pressure pricing and market share, compelling Takeda to innovate and diversify its offerings and indications.

3. Are there upcoming regulatory approvals that could affect VERDESO’s growth?
Yes, ongoing clinical trials exploring new indications and pediatric uses could expand its market, depending on regulatory outcomes.

4. What regions present the most significant growth opportunities for VERDESO?
Emerging markets such as Asia-Pacific, Latin America, and the Middle East offer substantial potential due to rising IBD prevalence and expanding healthcare access.

5. What are the key factors influencing VERDESO’s pricing strategy?
Market competitiveness, reimbursement policies, clinical efficacy, safety profile, and healthcare system budgets are critical determinants.

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Sources:

[1] Takeda Pharmaceuticals, “Vedolizumab (VERDESO) Prescribing Information,” 2022.
[2] Market Research Future, “Global IBD Therapeutics Market Analysis,” 2023.
[3] EvaluatePharma, “Biologic Market Share and Forecast,” 2023.
[4] FDA Approval Reports, 2014.
[5] Healthcare Economics Publications, “Impact of Biosimilars on Biologic Drugs,” 2022.