VESICARE Drug Patent Profile

When do Vesicare patents expire, and what generic alternatives are available?

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vesicare

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

Summary for VESICARE

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	172
Clinical Trials:	67
Patent Applications:	2,012
Drug Prices:	Drug price information for VESICARE
Drug Sales Revenues:	Drug sales revenues for VESICARE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VESICARE
What excipients (inactive ingredients) are in VESICARE?	VESICARE excipients list
DailyMed Link:	VESICARE at DailyMed

See drug prices for VESICARE

See drug sales revenues for VESICARE

Recent Clinical Trials for VESICARE

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 clinical trials

Pharmacology for VESICARE

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Paragraph IV (Patent) Challenges for VESICARE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VESICARE	Tablets	solifenacin succinate	5 mg and 10 mg	021518	1	2009-04-08

US Patents and Regulatory Information for VESICARE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518-001	Nov 19, 2004	AB	RX	Yes	No
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518-002	Nov 19, 2004	AB	RX	Yes	Yes
Astellas	VESICARE LS	solifenacin succinate	SUSPENSION;ORAL	209529-001	May 26, 2020		RX	Yes	Yes	9,918,970		Y

Expired US Patents for VESICARE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518-001	Nov 19, 2004	6,017,927*PED
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518-002	Nov 19, 2004	6,017,927*PED

International Patents for VESICARE

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

Country	Patent Number	Title	Estimated Expiration
Canada	2208839	DERIVES DE QUINUCLIDINE ET COMPOSITION PHARMACEUTIQUE LES CONTENANT (QUINUCLIDINE DERIVATIVES AND MEDICINAL COMPOSITION THEREOF)
Japan	3014457
European Patent Office	0801067	NOUVEAUX DERIVES DE QUINUCLIDINE ET COMPOSITION PHARMACEUTIQUE LES CONTENANT (NOVEL QUINUCLIDINE DERIVATIVES AND MEDICINAL COMPOSITION THEREOF)

Supplementary Protection Certificates for VESICARE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0801067	CA 2004 00037	Denmark
0801067	SPC014/2004	Ireland		SPC014/2004: 20050803, EXPIRES: 20181215
0801067	04C0032	France		PRODUCT NAME: SUCCINATE DE SOLIFENACINE; NAT. REGISTRATION NO/DATE: NL 30 109 20040816; FIRST REGISTRATION: NL - RVG 29 151 20031216

VESICARE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VESICARE

Introduction to VESICARE

VESICARE, also known as Solifenacin Succinate, is a medication used to treat overactive bladder (OAB) symptoms such as frequent or urgent urination, and incontinence. It belongs to the class of anticholinergic drugs and is marketed by Astellas Pharma Inc.

Global Market Size and Growth

The global Solifenacin Succinate market is experiencing significant growth. As of 2024, the global market size is estimated to be USD 102,151.2 million, with a projected compound annual growth rate (CAGR) of 50.90% from 2024 to 2031[1].

Regional Market Breakdown

North America

In North America, the Solifenacin Succinate market is substantial, with a sales revenue of USD 40,860.4 million in 2024. The United States dominates this region with a sales revenue of USD 32,238.9 million, growing at a CAGR of 48.9% from 2024 to 2031. Canada and Mexico also contribute significantly, with CAGRs of 49.9% and 49.6%, respectively[1].

Europe

Europe holds a significant market share, with a sales revenue of USD 30,645.3 million in 2024. The region is expected to grow at a CAGR of 49.4% from 2024 to 2031. Key markets include the United Kingdom, with a sales revenue of USD 5,148.42 million and a CAGR of 50.2%, and France, with a sales revenue of USD 2,819.37 million and a CAGR of 48.6%[1].

Asia Pacific

The Asia Pacific region accounts for around 23% of the global revenue, with a market size of USD 23,494.7 million in 2024. This region is expected to grow at a CAGR of 52.9% from 2024 to 2031, making it one of the fastest-growing markets for Solifenacin Succinate[1].

Latin America and Middle East & Africa

Latin America contributes around 5% of the global revenue, with a market size of USD 5,107.5 million in 2024, growing at a CAGR of 50.3%. The Middle East and Africa hold a smaller but still significant share, with a market size of USD 2,043 million in 2024 and a CAGR of 50.6% from 2024 to 2031[1].

Overactive Bladder Treatment Market Context

The broader overactive bladder treatment market, which includes drugs like Solifenacin Succinate, is also growing. The global overactive bladder treatment market was valued at USD 3.5 billion in 2022 and is expected to reach USD 4.2 billion by 2027, growing at a CAGR of 3.6% from 2022 to 2027. This growth is driven by an increasing number of patients with OAB, adequate reimbursement policies, and investments in novel drugs and devices[4].

Financial Performance of Astellas Pharma Inc.

Astellas Pharma Inc., the manufacturer of VESICARE, has seen varied financial performance in recent years. For the fiscal year 2021, Astellas reported a consolidated revenue of ¥1,296.2 billion, with a gross profit of ¥1,043.2 billion. However, the company faced significant challenges, including impairment losses and restructuring costs, which impacted their net income[5].

Revenue and Profit Margins

In the fiscal year 2021, Astellas's revenue from brand-name medicines, including VESICARE, was ¥1,249.5 billion. The gross profit margin was around 80%, indicating strong profitability from their pharmaceutical products. However, operating profit and net income were affected by various expenses and losses[5].

Impact of VESICARE on Financials

VESICARE is a significant contributor to Astellas's revenue. Despite the overall financial challenges faced by the company, the sales of VESICARE have been robust. The drug's performance is crucial for the company's financial health, given its market share and growth potential.

Competitive Landscape

The overactive bladder treatment market is competitive, with various drugs and treatment options available. Solifenacin Succinate competes with other anticholinergic drugs like Oxybutynin, Tolterodine, and Darifenacin, as well as with Mirabegron, which has fewer side effects compared to anticholinergics[4].

Side Effects and Patient Preference

The side effect profile of VESICARE, as outlined in its product monograph, includes dry mouth, constipation, and vision blurred, among others. While these side effects are common in anticholinergic drugs, they can influence patient preference and adherence to treatment. Mirabegron, with its fewer side effects, poses a competitive challenge to VESICARE[3].

Market Drivers and Challenges

Drivers

• Increasing Prevalence of Overactive Bladder: The growing number of patients with OAB is a key driver for the market.
• Adequate Reimbursement Policies: Favorable reimbursement policies for OAB treatments support market growth.
• Investment in Novel Drugs and Devices: Continuous investment in research and development of new treatments is driving the market forward[4].

Challenges

• Product Recalls: Any recalls of Solifenacin Succinate or similar drugs can negatively impact market growth.
• Social Stigma: Social stigma associated with OAB can reduce the number of patients seeking treatment.
• Competition from Alternative Treatments: The availability of alternative treatments, such as Botox and neuromodulation, can divert market share away from pharmaceuticals like VESICARE[4].

Future Outlook

Given the robust growth projections for the Solifenacin Succinate market, VESICARE is poised to continue playing a significant role in the treatment of overactive bladder. The drug's strong market presence, combined with the increasing prevalence of OAB and favorable reimbursement policies, suggests a bright financial trajectory for Astellas Pharma Inc. in this segment.

Key Takeaways

• Global Market Growth: The global Solifenacin Succinate market is expected to grow at a CAGR of 50.90% from 2024 to 2031.
• Regional Dominance: North America and Europe are significant markets, with Asia Pacific showing the highest growth rate.
• Competitive Landscape: VESICARE competes with other anticholinergic drugs and Mirabegron.
• Financial Performance: Astellas Pharma Inc.'s revenue is significantly influenced by VESICARE sales.
• Market Drivers and Challenges: Increasing OAB prevalence, reimbursement policies, and investment in new treatments drive the market, while product recalls and social stigma pose challenges.

FAQs

What is the projected global market size for Solifenacin Succinate in 2024?

The global Solifenacin Succinate market size is estimated to be USD 102,151.2 million in 2024[1].

What is the CAGR for the Solifenacin Succinate market from 2024 to 2031?

The CAGR for the Solifenacin Succinate market from 2024 to 2031 is 50.90%[1].

Which region has the highest growth rate for Solifenacin Succinate?

The Asia Pacific region has the highest growth rate, with a CAGR of 52.9% from 2024 to 2031[1].

What are the main side effects of VESICARE?

Common side effects include dry mouth, constipation, vision blurred, and others as outlined in the product monograph[3].

How does VESICARE compete in the overactive bladder treatment market?

VESICARE competes with other anticholinergic drugs and Mirabegron, which has fewer side effects[4].

Sources

1. Cognitive Market Research - Solifenacin Succinate Market Report 2024 (Global Edition)
2. Servier - Servier confirms its 2025 trajectory to achieve its 2030 ambition
3. Astellas Pharma Inc. - Vesicare Product Monograph
4. MarketsandMarkets - Overactive Bladder Treatment Market Size And Global Industry
5. Astellas Pharma Inc. - Financial results for the fiscal year 2021 (FY2021)