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, Bostal, Breckenridge, Chartwell Rx, Cipla, Glenmark Speclt, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, MSN, Novitium Pharma, Qilu, Rising, Sciegen Pharms Inc, Sunshine, Teva Pharms Usa, Torrent, Unichem, Watson Labs Inc, and Zydus Pharms, and is included in twenty-eight 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-two suppliers are listed for this compound.

Summary for solifenacin succinate

International Patents:	23
US Patents:	1
Tradenames:	3
Applicants:	27
NDAs:	28
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	59
Patent Applications:	3,589
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
Xing Liu	NA
Shanghai University of Traditional Chinese Medicine	N/A
Longhua Hospital	N/A

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
Annora Pharma	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	215761-002	Jun 15, 2022	AB	RX	No	No
Aurobindo Pharma	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	206817-002	Dec 27, 2022	AB	RX	No	No
Glenmark Speclt	SOLIFENACIN SUCCINATE	solifenacin succinate	TABLET;ORAL	209239-001	May 20, 2019	AB	RX	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	6,017,927*PED
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518-002	Nov 19, 2004	6,017,927*PED

International Patents for solifenacin succinate

Country	Patent Number	Title	Estimated Expiration
Croatia	P20160901
Serbia	55044	FARMACEUTSKA KOMPOZICIJA KOJA SADRŽI SOLIFENACIN (PHARMACEUTICAL COMPOSITION CONTAINING SOLIFENACIN)
European Patent Office	2572717	COMPOSITION PHARMACEUTIQUE CONTENANT DE LA SOLIFÉNACINE (PHARMACEUTICAL COMPOSITION CONTAINING SOLIFENACIN)

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

Market Dynamics and Financial Trajectory for Solifenacin Succinate

Last updated: November 15, 2025

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Introduction

Solifenacin succinate is a selective antimuscarinic agent primarily prescribed for overactive bladder (OAB) treatment. Its distinctive profile as a once-daily oral medication engages significant market interest given the prevalence of OAB and related urinary conditions globally. Understanding its market dynamics and financial trajectory equips pharmaceutical stakeholders with essential insights into growth potential, competitive landscape, and strategic positioning.

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Pharmacological Profile and Therapeutic Importance

Solifenacin succinate, marketed under brand names such as Vesicare, stands out due to its enhanced selectivity for M3 muscarinic receptors in the bladder, resulting in improved efficacy and fewer systemic side effects relative to earlier antimuscarinics [1]. Its pharmacokinetic profile facilitates adherence through once-daily dosing, aligning with current patient preferences for convenience. The drug’s efficacy in reducing urinary urgency, frequency, and incontinence has solidified its role in managing OAB, contributing to steady demand.

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Market Overview & Trends

Global Prevalence of Overactive Bladder

The global prevalence of OAB is approximately 12-16%, impacting millions and fueling ongoing demand for effective therapies [2]. The associated healthcare costs, spanning direct medical expenses and indirect productivity losses, surpass USD 16 billion annually, reinforcing the economic importance of efficacious treatments like solifenacin.

Key Market Players & Competition

Major pharmaceutical companies like AstraZeneca (original developer), Pfizer, and Astellas have historical stakes in the antimuscarinic segment. The introduction of generic formulations post-patent expiry significantly influences market pricing dynamics and volume sales. As of 2023, the dominant landscape comprises branded Solifenacin (Vesicare) alongside a growing portfolio of generics, affecting revenue streams and profit margins.

Regulatory Approvals & Market Expansion

Regulatory approval processes across regions—US FDA, EMA, and others—continue to evolve, with particular emphasis on safety profiles and biosimilar entry pathways. The drug’s approval in emerging markets further broadens the geographic footprint, albeit with variations in market access and reimbursement frameworks.

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Market Drivers and Restraints

Drivers

• Increasing OAB Prevalence: Aging populations, notably in North America and Europe, drive sustained demand.
• Advancement in Pharmacology: Improved selectivity and tolerability enhance patient compliance and expand prescription rates.
• Broadening Indications: Ongoing research explores solifenacin’s utility in neurogenic bladder and other urological conditions, potentially extending market reach [3].

Restraints

• Competitive Landscape: The proliferation of generic alternatives exerts downward pressure on prices.
• Safety Concerns: Risks such as dry mouth, constipation, and cognitive effects in elderly populations can limit uptake.
• Reimbursement Variance: Payor policies differ globally, influencing patient access and sales volumes.

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Financial Trajectory Analysis

Historical Revenue and Sales Trends

Initially launched in 2005, solifenacin achieved rapid uptake due to its favorable profile, peaking around 2010 with annual sales exceeding USD 1 billion [4]. Post-patent expiry in key markets (e.g., US in 2018 for Vesicare), sales declined sharply, with generic competition, but stabilization occurs through increased adoption in emerging markets and expanding indications.

Impact of Patent Expiry and Generics

Patent expiration introduced price erosion, decreasing brand revenues by approximately 30-50%. However, price competition and increased volume sales in developing regions mitigated revenue decline. The drug’s market share shifted from branded dominance to a more balanced landscape incorporating multiple generic manufacturers.

Current and Projected Future Earnings

Forecasts suggest that the global solifenacin market will recover and grow modestly, driven by:

• Market Penetration in Emerging Economies: CAGR of approximately 4-6% over the next five years.
• Pipeline Developments: New formulations, combination therapies, and novel delivery methods could enhance revenues.
• Increased Adoption in Related Conditions: Neurogenic bladder and other urological disorders present revenue diversification opportunities.

The Financial Trajectory is expected to stabilize around USD 600-800 million in annual sales by 2025 in mature markets, with potential for growth in underpenetrated regions.

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Strategic Opportunities & Challenges

Opportunities

• Generic Market Expansion: Lower-cost options enhance access, increasing overall volume.
• Product Differentiation: Extended-release formulations or combination products offer competitive advantages.
• Digital Health Integration: Digital adherence tools could improve outcomes, fostering brand loyalty.

Challenges

• Pricing Pressures: Cost containment policies threaten profit margins.
• Regulatory Hurdles: Variability across jurisdictions complicates global rollout.
• Safety Profile Management: Ensuring minimal adverse effects remains critical to sustain market trust.

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Conclusion

Solifenacin succinate sustains a vital role within the OAB therapeutic landscape, despite challenges from generic competition and regulatory dynamics. Its financial trajectory demonstrates resilience, particularly through strategic expansion into emerging markets and pipeline innovations. Stakeholders must navigate pricing, safety, and market access considerations to optimize long-term value and market share.

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Key Takeaways

• The global overactive bladder market underpins ongoing demand for solifenacin succinate, with growth driven by aging demographics and expanding indications.
• Patent expirations and generic entry have significantly impacted revenues, yet brand variants maintain relevance through targeted differentiation and regional expansion.
• Financial outlooks project stabilized revenues of USD 600-800 million annually by 2025, with growth in less saturated markets.
• Strategic focus on product innovation, market access, and utilization of digital health tools will be critical for sustaining profitability.
• Navigating safety concerns and regulatory environments remains essential to maintain market trust and competitive advantage.

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FAQs

1. How has patent expiration affected solifenacin’s market share?
Patent expiry has introduced significant generic competition, leading to price declines and reduced brand sales. However, market penetration in emerging regions and new formulations help sustain revenues.

2. What are the key safety concerns associated with solifenacin succinate?
Common side effects include dry mouth, constipation, and blurred vision. Cognitive effects in elderly patients are also noted, necessitating careful patient selection.

3. Which regions hold the highest growth potential for solifenacin?
Emerging markets in Asia, Latin America, and the Middle East present substantial growth opportunities due to increasing prevalence and improving healthcare infrastructure.

4. How might pipeline developments impact its future market?
Innovations such as extended-release formulations or oligonucleotide combinations could broaden indications and improve adherence, boosting future sales.

5. What strategic moves could pharmaceutical companies adopt to maximize profitability?
Investing in biosimilars, expanding indications, entering new geographies, and leveraging digital adherence strategies can enhance market positioning and financial outcomes.

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Sources

[1] U.S. Food and Drug Administration. Vesicare (Solifenacin) Prescribing Information.
[2] Milsom, I., et al. (2012). Global prevalence and burden of overactive bladder. European Urology.
[3] Fesler, S. D., et al. (2018). Expanded therapeutic applications of solifenacin. Urology Journal.
[4] Company Annual Reports and Market Research Data (2010–2022).