Solifenacin succinate - Generic Drug Details

What are the generic sources for solifenacin succinate and what is the scope of freedom to operate?

Solifenacin succinate is the generic ingredient in three branded drugs marketed by Astellas, Accord Hlthcare, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Annora Pharma, Aurobindo Pharma, Austarpharma, Breckenridge, Chartwell Rx, Cipla, Esjay Pharma, Glenmark Speclt, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, MSN, Qilu, Rising, Sciegen Pharms Inc, Sunshine, Teva Pharms Usa, Unichem, Watson Labs Inc, and Zydus Pharms, and is included in twenty-seven NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Solifenacin succinate has twenty-three patent family members in twenty-one countries.

There are twenty-nine drug master file entries for solifenacin succinate. Twenty-six suppliers are listed for this compound.

Summary for solifenacin succinate

International Patents:	23
US Patents:	1
Tradenames:	3
Applicants:	26
NDAs:	27
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	58
Patent Applications:	3,267
Drug Prices:	Drug price trends for solifenacin succinate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for solifenacin succinate
What excipients (inactive ingredients) are in solifenacin succinate?	solifenacin succinate excipients list
DailyMed Link:	solifenacin succinate at DailyMed

See drug prices for solifenacin succinate

Recent Clinical Trials for solifenacin succinate

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

Sponsor	Phase
Shanghai University of Traditional Chinese Medicine	N/A
Longhua Hospital	N/A
Hikma Pharma	Phase 1

See all solifenacin succinate clinical trials

Pharmacology for solifenacin succinate

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for solifenacin succinate

Muscarinic Antagonists

Urological Agents

Anatomical Therapeutic Chemical (ATC) Classes for solifenacin succinate

G04BD	Drugs for urinary frequency and incontinence
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for SOLIFENACIN SUCCINATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VESICARE LS	Oral Suspension	solifenacin succinate	1 mg/mL	209529	1	2021-05-27
VESICARE	Tablets	solifenacin succinate	5 mg and 10 mg	021518	1	2009-04-08

US Patents and Regulatory Information for solifenacin succinate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	206817-002	Dec 27, 2022	AB	RX	No	No
Aurobindo Pharma	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	206817-001	Dec 27, 2022	AB	RX	No	No
Ajanta Pharma Ltd	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	205483-001	May 20, 2019		DISCN	No	No
Chartwell Rx	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	210582-002	May 20, 2019	AB	RX	No	No
Annora Pharma	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	215761-002	Jun 15, 2022	AB	RX	No	No
Sunshine	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	213346-001	Apr 13, 2020		DISCN	No	No

Expired US Patents for solifenacin succinate

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

International Patents for solifenacin succinate

Country	Patent Number	Title	Estimated Expiration
Croatia	P20160901
Spain	2588008
Brazil	112012029461	composição farmacêutica contendo solifenacina
Mexico	2012013328	COMPOSICION FARMACEUTICA QUE CONTIENE SOLIFENACINA. (PHARMACEUTICAL COMPOSITION CONTAINING SOLIFENACIN.)
Taiwan	201208684	Pharmaceutical composition comprising solifenacin
Japan	WO2011145642	ソリフェナシン含有医薬組成物

Supplementary Protection Certificates for solifenacin succinate

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

Solifenacin succinate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Solifenacin Succinate

Introduction

Solifenacin succinate, a medication primarily used to treat overactive bladder (OAB) symptoms, has been gaining significant traction in the global pharmaceutical market. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of the solifenacin succinate market.

Global Market Size and Growth

As of 2024, the global solifenacin succinate market size is estimated to be USD 102,151.2 million. This market is projected to experience robust growth, reaching USD 1,819,986.4 million by 2031, with a compound annual growth rate (CAGR) of 50.90% from 2024 to 2031[1].

Regional Market Breakdown

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

North America

North America holds the largest market share, with a market size of USD 40,860.4 million in 2024. The region is expected to grow at a CAGR of 49.1% from 2024 to 2031. The United States and Canada are the key contributors, with the U.S. market valued at USD 32,238.9 million and Canada at USD 4,903.26 million in 2024[1].

Europe

Europe accounts for more than 30% of the global revenue, with a market size of USD 30,645.3 million in 2024. The European market is anticipated to grow at a CAGR of 49.4% from 2024 to 2031[1].

Asia Pacific

The Asia Pacific region holds 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, driven by countries like India and Australia[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also contribute to the global market, with market sizes of USD 5,107.5 million and USD 2,043.0 million, respectively, in 2024. These regions are expected to grow at CAGRs of 50.3% and 50.6%, respectively, from 2024 to 2031[1].

Drivers of Market Growth

Several factors are driving the growth of the solifenacin succinate market:

Increasing Healthcare Investments

Rising investments in healthcare infrastructure, particularly in developing countries, are boosting the demand for effective treatments for urinary disorders[1].

Growing Prevalence of Chronic Conditions

The increasing prevalence of chronic conditions such as overactive bladder is a significant driver. As the global population ages, the incidence of OAB is expected to rise, driving the demand for solifenacin succinate[1].

Rising Awareness and Diagnosis

Improved diagnostic techniques and rising awareness about urinary disorders are leading to more patients seeking treatment, thereby expanding the market[1].

Cost-Effectiveness and Economic Impact

Studies have evaluated the cost-effectiveness of solifenacin succinate compared to other antimuscarinic agents:

Cost-Effectiveness Analysis

In a Canadian cost-effectiveness analysis, solifenacin was found to be cost-effective compared to oxybutynin IR when considering the costs of incontinence pads. Solifenacin resulted in an incremental saving of CAN$1,831 per patient and an incremental QALY gain of 0.01 over one year[2].

Comparative Analysis

A UK-based study compared the cost-effectiveness of solifenacin with other antimuscarinic agents. Solifenacin provided the greatest clinical benefit and associated QALYs for urgency, frequency, and incontinence outcomes but was not cost-effective relative to oxybutynin IR for frequency and incontinence outcomes[5].

Market Segmentation

The solifenacin succinate market is segmented based on type and application:

Type

The market is segmented into different types of solifenacin succinate formulations, including tablets and other dosage forms. Each type has its own market share and growth prospects[1].

Application

The primary application of solifenacin succinate is in the treatment of overactive bladder. However, its use can also extend to other urinary disorders, contributing to its market growth[1].

Technological and Regulatory Factors

Technological advancements in drug formulation and delivery systems are enhancing the efficacy and tolerability of solifenacin succinate. Regulatory approvals and compliance with healthcare standards also play a crucial role in the market's growth[4].

Competitive Landscape

The solifenacin succinate market is competitive, with several pharmaceutical companies involved in its production and distribution. The competitive landscape is influenced by factors such as pricing, product innovation, and marketing strategies[4].

Future Market Opportunities

The future of the solifenacin succinate market looks promising due to several factors:

Expanding Healthcare Infrastructure

The development of healthcare infrastructure in developing nations is expected to increase the demand for solifenacin succinate[1].

Growing Demand for Minimally Invasive Treatments

The increasing preference for minimally invasive treatments and better patient outcomes is likely to drive the market forward[4].

Technological Innovations

Continuous technological innovations in drug delivery systems and formulations will enhance the market's growth potential[4].

Key Takeaways

• The global solifenacin succinate market is projected to grow significantly, reaching USD 1,819,986.4 million by 2031.
• North America holds the largest market share, followed by Europe and Asia Pacific.
• Increasing healthcare investments, growing prevalence of chronic conditions, and rising awareness are key drivers of market growth.
• Solifenacin succinate is cost-effective compared to other antimuscarinic agents in certain scenarios.
• Technological advancements and regulatory factors are crucial for market growth.

FAQs

Q: What is the current global market size of solifenacin succinate? A: The global solifenacin succinate market size was estimated at USD 102,151.2 million in 2024[1].

Q: What is the projected CAGR of the solifenacin succinate market from 2024 to 2031? A: The market is expected to grow at a CAGR of 50.90% from 2024 to 2031[1].

Q: Which region holds the largest market share for solifenacin succinate? A: North America holds the largest market share, with a market size of USD 40,860.4 million in 2024[1].

Q: Is solifenacin succinate cost-effective compared to other antimuscarinic agents? A: Solifenacin succinate is cost-effective in certain scenarios, particularly when considering the costs of incontinence pads, but not always compared to oxybutynin IR[2][5].

Q: What are the key drivers of the solifenacin succinate market growth? A: Key drivers include increasing healthcare investments, growing prevalence of chronic conditions, and rising awareness and diagnosis of urinary disorders[1].

Sources

1. Cognitive Market Research, "Solifenacin Succinate Market Report 2024 (Global Edition)".
2. PubMed, "Canadian cost-effectiveness analysis of solifenacin compared to oxybutynin immediate-release".
3. Market Research Intellect, "Global Solifenacin Succinate Drug Market Size and Forecast".
4. Market Research Intellect, "Solifenacin Succinate Market Size, Share, Growth & Forecast [2031]".
5. PubMed, "The cost-effectiveness of solifenacin vs fesoterodine, oxybutynin".