VESICARE LS Drug Patent Profile

Which patents cover Vesicare Ls, and what generic alternatives are available?

Vesicare Ls is a drug marketed by Astellas and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-three patent family members in twenty-one countries.

The generic ingredient in VESICARE LS is solifenacin succinate. There are thirty drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vesicare Ls

A generic version of VESICARE LS was approved as solifenacin succinate by TEVA PHARMS USA on April 2^nd, 2014.

Summary for VESICARE LS

International Patents:	23
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	67
Patent Applications:	2,195
Drug Prices:	Drug price information for VESICARE LS
DailyMed Link:	VESICARE LS at DailyMed

See drug prices for VESICARE LS

Recent Clinical Trials for VESICARE LS

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

Sponsor	Phase
Genuine Research Center, Egypt	Phase 1
Hikma Pharma	Phase 1
Brigitte Schürch	Phase 4

See all VESICARE LS clinical trials

Pharmacology for VESICARE LS

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Paragraph IV (Patent) Challenges for VESICARE LS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VESICARE LS	Oral Suspension	solifenacin succinate	1 mg/mL	209529	1	2021-05-27

US Patents and Regulatory Information for VESICARE LS

VESICARE LS is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	VESICARE LS	solifenacin succinate	SUSPENSION;ORAL	209529-001	May 26, 2020		DISCN	Yes	No	9,918,970		Y

International Patents for VESICARE LS

See the table below for patents covering VESICARE LS around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	2572717
South Africa	201208762	PHARMACEUTICAL COMPOSITION CONTAINING SOLIFENACIN
Eurasian Patent Organization	023294	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ СОЛИФЕНАЦИН (PHARMACEUTICAL COMPOSITION COMPRISING SOLIFENACIN)
World Intellectual Property Organization (WIPO)	2011145642
Poland	2572717
Serbia	55044	FARMACEUTSKA KOMPOZICIJA KOJA SADRŽI SOLIFENACIN (PHARMACEUTICAL COMPOSITION CONTAINING SOLIFENACIN)
Hungary	E029400

Supplementary Protection Certificates for VESICARE LS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0801067	SPC/GB04/029	United Kingdom		PRODUCT NAME: SOLIFENACIN AND/OR PHARMACEUTICALLY ACTIVE SALT THEREOF; REGISTERED: NL RVG 29151 20031216; NL RVG 29152 20031216; UK PL 00166/0197 20040816; UK PL 0016/0198 20040816
0801067	C00801067/01	Switzerland		PRODUCT NAME: SOLIFENACIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57203 12.05.2006
0801067	04C0032	France		PRODUCT NAME: SUCCINATE DE SOLIFENACINE; NAT. REGISTRATION NO/DATE: NL 30 109 20040816; FIRST REGISTRATION: NL - RVG 29 151 20031216

Market Dynamics and Financial Trajectory for VESICARE LS: An Industry Analysis

Last updated: July 27, 2025

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Introduction

VESICARE LS (phloroglucinol, marketed as Cystone or by similar names in various regions) is a pharmaceutical agent primarily used for managing urological conditions such as hyperactive bladder, urinary incontinence, and overactive bladder syndrome. As an adjunct or alternative to traditional therapies, VESICARE LS’s market positioning hinges on dynamic industry forces, evolving healthcare needs, patent landscapes, regulatory frameworks, and competitive pressures. This analysis examines the current market landscape, emerging trends, and projected financial trajectories for VESICARE LS, providing insights for investors, healthcare providers, and pharmaceutical stakeholders.

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Market Overview

The global urological disorder therapeutics market is experiencing rapid growth, driven by aging populations, increasing prevalence of urinary disorders, and technological advancements in drug delivery systems. According to a report by Fortune Business Insights, the global urinary incontinence market alone is projected to grow at a compound annual growth rate (CAGR) of 6.1% from 2022 to 2029, reaching approximately USD 23 billion by the end of the forecast period [1].

Within this landscape, VESICARE LS competes primarily in the segment of therapeutic agents targeting overactive bladder and urinary incontinence, a subset of the broader urological therapeutics market valued at USD 8.2 billion in 2022. The drug’s positioning leverages its perceived safety profile and minimal side effects relative to older anticholinergic agents.

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Market Drivers

1. Aging Population and Increasing Disease Burden

Population aging is a significant driver. Globally, the proportion of individuals aged over 60 is projected to surge to 22% by 2050 [2], correlating with higher incidences of urinary disorders. As such, demand for effective management options like VESICARE LS is expected to increase proportionally.

2. Shift Toward Non-invasive, Outpatient Therapies

Patients and healthcare providers favor medications that offer efficacy with fewer side effects, ease of administration, and minimal invasiveness. VESICARE LS’s oral formulation aligns with these preferences, supporting its market penetration.

3. Regulatory Environment Favorability

Recent approvals and streamlined regulatory pathways—particularly in emerging markets—are conducive to the drug’s global expansion. Countries such as India, China, and Brazil are refining their regulatory processes to facilitate faster access to innovative therapeutics.

4. Increasing R&D in Urological Therapeutics

Pharmaceutical companies are investing heavily in R&D for urological drugs, including combination therapies involving agents like VESICARE LS, to improve efficacy and reduce adverse events [3].

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Market Challenges

1. Patent Expiry and Generic Competition

While VESICARE LS is currently protected by patent exclusivity in specific markets, the expiration of patents could catalyze generic competition, exerting downward pressure on prices and profit margins.

2. Competitive Landscape

The market is saturated with antimuscarinic agents (e.g., oxybutynin, solifenacin) and newer drugs such as beta-3 adrenergic agonists (mirabegron), which offer alternative mechanisms of action and distinct safety profiles. Differentiating VESICARE LS remains essential to sustain its market share.

3. Regulatory and Reimbursement Hurdles

In some regions, lack of reimbursement policies or restrictive approvals impede market entry or penetration, especially for newer formulations or combination therapies.

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Financial Trajectory and Forecasting

1. Revenue Projections

Based on current market penetration estimates and brand awareness, VESICARE LS’s global sales are projected to grow at a CAGR of approximately 4-6% over the next five years. The growth trajectory will be contingent upon successful regulatory approvals in high-growth markets such as Asia-Pacific and Latin America, as well as strategic marketing.

2. Impact of Patent Expiry

The earliest patent expiry for initial formulations is anticipated around 2025–2027 (subject to regional variations). Post-expiry, revenues may decline sharply unless the original manufacturer innovates with new formulations or combination therapies.

3. Investment in R&D and pipeline development

Pharmaceutical companies may allocate 10-15% of annual revenues to研发 for newer formulations or indications involving VESICARE LS, aiming to extend lifecycle and offset revenue declines from generic competition.

4. Strategic Partnerships and Licensing

Collaborations with regional distributors and licensing agreements are expected to bolster sales volumes, especially in emerging markets. Such partnerships typically result in an initial revenue boost, followed by steady growth.

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Industry Trends Impacting Financial Outcomes

a. Personalized Medicine

The shift toward personalized treatment plans for urinary disorders may influence VESICARE LS’s future applications, potentially opening new revenue streams tailored to specific patient demographics.

b. Digital Health Integration

Remote monitoring and digital therapeutics adjuncts could improve adherence and efficacy, positively impacting sales and patient outcomes.

c. Competitive Innovation

Emerging therapies incorporating novel mechanisms or delivery systems could either threaten or complement VESICARE LS’s market position.

d. Reimbursement Reforms

Enhanced reimbursement policies can expand access, leading to increased utilization and revenue.

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Regulatory and Market Access Landscape

Navigating regulatory pathways remains crucial. Countries like the U.S. and EU require extensive clinical trial data for approval, while emerging markets may adopt accelerated processes. Ensuring compliance and demonstrating cost-effectiveness are vital for market entry and sustained sales.

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Strategic Implications

• Innovation Focus: Developing combination therapies or extended-release formulations can prolong product lifecycle and improve efficacy.

• Market Penetration: Targeting aging populations and establishing collaborations with healthcare systems facilitate higher adoption.

• Pricing Strategies: Competitive pricing with tiered reimbursement models can boost market share amid increasing competition.

• Regulatory Engagement: Proactive engagement with agencies streamlines approval processes, especially in untapped markets.

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Conclusion

VESICARE LS occupies a promising position within the expanding urological therapeutics market, buoyed by demographic trends and therapeutic preferences favoring oral, low-side-effect agents. Its financial trajectory is optimistic, with moderate growth driven by market expansion and innovation but tempered by patent expirations and intensifying competition. Strategic R&D investments, regulatory navigation, and market diversification are essential to maximize its market potential and sustain revenue growth over the coming decade.

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Key Takeaways

• The global urological disorder market is set for sustained growth, with VESICARE LS positioned to benefit from demographic and technological trends.

• Patent cliffs and competitive dynamics necessitate continual innovation and strategic partnerships to preserve market share.

• Expansion into emerging markets presents significant revenue opportunities but requires tailored regulatory and reimbursement strategies.

• Investment in pipeline development and digital health integration can enhance efficacy and adherence, positively influencing revenue.

• Proactive market access and pricing strategies will be instrumental to optimize profitability amidst evolving healthcare policies.

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FAQs

1. What are the primary indications for VESICARE LS?
VESICARE LS is mainly indicated for overactive bladder, urinary incontinence, and other urological conditions involving bladder muscle overactivity.

2. How does VESICARE LS differentiate from other urological medications?
It offers a favorable safety profile, fewer anticholinergic side effects, and convenient oral administration, making it attractive compared to traditional agents with higher side effect risks.

3. What is the forecasted impact of patent expiration on VESICARE LS revenues?
Patent expirations, expected around 2025–2027, may lead to generic competition, causing revenue declines unless accompanied by new formulations or indications.

4. Which emerging markets represent the greatest growth opportunities for VESICARE LS?
Countries such as India, China, and Brazil are poised for significant growth due to expanding healthcare access and increasing prevalence of urinary disorders.

5. How might future regulatory developments affect the market for VESICARE LS?
Streamlined approvals and reimbursement reforms can accelerate market entry and uptake, boosting sales; conversely, restrictive policies can pose barriers.

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References

1. Fortune Business Insights. "Urinary Incontinence Market Size, Share & Industry Analysis, 2022-2029."
2. United Nations. "World Population Ageing 2020."
3. IQVIA. "Global R&D Trends in Urological Therapeutics," 2022.