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-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 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:	2,012
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
Hikma Pharma	Phase 1
Genuine Research Center, Egypt	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		RX	Yes	Yes	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
Croatia	P20160901
Spain	2588008
Brazil	112012029461	composição farmacêutica contendo solifenacina

Supplementary Protection Certificates for VESICARE LS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0801067	04C0032	France		PRODUCT NAME: SUCCINATE DE SOLIFENACINE; NAT. REGISTRATION NO/DATE: NL 30 109 20040816; FIRST REGISTRATION: NL - RVG 29 151 20031216
0801067	C00801067/01	Switzerland		PRODUCT NAME: SOLIFENACIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57203 12.05.2006
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

VESICARE LS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VESICARE LS

Introduction

VESICARE LS, marketed by Astellas Pharma Inc., is a prescription medicine containing the active ingredient solifenacin succinate. It is primarily used to treat neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older. Here, we delve into the market dynamics and financial trajectory of VESICARE LS.

Market Size and Growth

The global solifenacin succinate market, which includes VESICARE LS, is projected to experience significant growth. According to Cognitive Market Research, the global solifenacin succinate market size is estimated to be USD 102,151.2 million in 2024 and is expected to expand at a compound annual growth rate (CAGR) of 50.90% from 2024 to 2031, reaching USD 1,819,986.4 million by 2031[3].

Regional Market Breakdown

The market for solifenacin succinate is distributed across various regions, each with its own growth trajectory:

• North America: Expected to grow at a CAGR of 49.1% from 2024 to 2031, with the United States contributing significantly to this growth[3].
• Europe: Holds more than 30% of the global revenue, with a market size of USD 30,645.3 million in 2024 and a CAGR of 49.4% from 2024 to 2031[3].
• Asia Pacific: Accounts for around 23% of the global revenue, with a market size of USD 23,494.7 million in 2024 and a CAGR of 52.9% from 2024 to 2031[3].
• Latin America and Middle East & Africa: These regions also show promising growth, with CAGRs of 50.3% and 50.6%, respectively, from 2024 to 2031[3].

Patent and Regulatory Landscape

VESICARE LS is protected by one US patent and has faced one Paragraph IV challenge, indicating potential competition from generic versions. A generic version of solifenacin succinate was approved by TEVA PHARMS USA in 2014, which could impact the market dynamics of VESICARE LS[1].

FDA Approval and Clinical Significance

The FDA approval of VESICARE LS in May 2020 marked a significant milestone, as it provided a new treatment option for pediatric patients with neurogenic detrusor overactivity. This approval highlights Astellas' commitment to advancing treatment options for urologic conditions and addresses a previously limited treatment landscape for children with NDO[4].

Dosage and Administration

VESICARE LS is available as an oral suspension, specifically developed to facilitate dosing and administration in pediatric patients. This formulation is crucial for managing the condition effectively in children, who may have difficulty with tablet forms[4].

Financial Performance

The financial performance of VESICARE LS is closely tied to the overall performance of Astellas Pharma Inc. and the broader solifenacin succinate market. Here are some key financial indicators:

• Revenue Growth: The significant CAGR of the solifenacin succinate market indicates strong revenue growth potential for VESICARE LS.
• Market Share: Astellas' commitment to R&D and its strategic focus on urologic conditions help maintain a competitive market share.
• Cost and Pricing: The availability of generic versions could impact pricing strategies, but the unique formulation of VESICARE LS for pediatric use may help maintain premium pricing[1][3].

Competitive Landscape

The competitive landscape for VESICARE LS includes both branded and generic versions of solifenacin succinate. Key competitors include:

• Generic Manufacturers: Companies like TEVA PHARMS USA, which have already received approval for generic versions.
• Other Branded Products: Other medications targeting similar conditions, although VESICARE LS's pediatric focus provides a niche market advantage[1].

Future Outlook

The future outlook for VESICARE LS is promising due to several factors:

• Increasing Healthcare Investments: Growing investments in healthcare and rising awareness of urinary disorders are expected to drive demand.
• Expanding Patient Base: The approval for pediatric use expands the patient base, contributing to market growth.
• Innovative Formulations: The oral suspension formulation enhances patient compliance and satisfaction, particularly in pediatric patients[3][4].

Challenges and Opportunities

Despite the positive outlook, there are challenges and opportunities to consider:

• Generic Competition: The presence of generic versions could reduce market share and pricing power.
• Regulatory Environment: Changes in regulatory policies or additional approvals for competitors could impact market dynamics.
• R&D Investments: Continued investment in R&D can help Astellas maintain a competitive edge and explore new indications or formulations[1][3].

Key Takeaways

• Market Growth: The solifenacin succinate market, including VESICARE LS, is expected to grow significantly at a CAGR of 50.90% from 2024 to 2031.
• Regional Variance: Different regions show varying growth rates, with North America, Europe, and Asia Pacific being key markets.
• Regulatory Approval: FDA approval for pediatric use has expanded the patient base and treatment options.
• Competitive Landscape: The presence of generic versions and other branded products necessitates strategic marketing and R&D investments.

FAQs

What is VESICARE LS used for?

VESICARE LS is a prescription medicine used to treat neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older. It helps increase the amount of urine the bladder can hold and reduce urine leakage[4].

Who is the manufacturer of VESICARE LS?

VESICARE LS is manufactured and marketed by Astellas Pharma Inc.[1].

What is the active ingredient in VESICARE LS?

The active ingredient in VESICARE LS is solifenacin succinate[1].

What is the expected market size of the solifenacin succinate market by 2031?

The global solifenacin succinate market is expected to reach USD 1,819,986.4 million by 2031, growing at a CAGR of 50.90% from 2024 to 2031[3].

Is there a generic version of VESICARE LS available?

Yes, a generic version of solifenacin succinate was approved by TEVA PHARMS USA in 2014[1].

Sources

1. DrugPatentWatch: VESICARE LS Drug Patent Profile.
2. GSK Annual Report 2013: Annual Report 2013 | GSK.
3. Cognitive Market Research: Solifenacin Succinate Market Report 2024 (Global Edition).
4. PR Newswire: FDA Approves VESIcare LS™ (solifenacin succinate) Oral Suspension for Pediatric Patients.