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-one 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:	1
Clinical Trials:	67
Patent Applications:	2,195
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		DISCN	Yes	No			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
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518-002	Nov 19, 2004

International Patents for VESICARE

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

Country	Patent Number	Title	Estimated Expiration
Japan	3014457
Hungary	T77006
Hungary	223778	Új kinuklidinszármazékok és ezeket tartalmazó gyógyászati készítmények (NOVEL QUINUCLIDINE DERIVATIVES AND MEDICINAL COMPOSITION THEREOF)
Taiwan	305842

Supplementary Protection Certificates for VESICARE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0801067	CA 2004 00037	Denmark
0801067	04C0032	France		PRODUCT NAME: SUCCINATE DE SOLIFENACINE; NAT. REGISTRATION NO/DATE: NL 30 109 20040816; FIRST REGISTRATION: NL - RVG 29 151 20031216
0801067	SPC014/2004	Ireland		SPC014/2004: 20050803, EXPIRES: 20181215
0801067	C00801067/01	Switzerland		PRODUCT NAME: SOLIFENACIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57203 12.05.2006

Market Dynamics and Financial Trajectory for VESICARE (Tegaserod)

Last updated: December 18, 2025

Summary

VESICARE (generic name: Tegaserod) is a prescription medication primarily indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women under 65 and chronic idiopathic constipation (CIC) in adults. Originally launched by Novartis in 2002, Tegaserod faced market withdrawal in 2007 due to safety concerns but has re-entered the market after stringent regulatory re-approvals in 2019. This article analyzes the evolving market dynamics, regulatory landscape, and financial outlook for VESICARE, integrating recent sales trends, competitive positioning, and growth drivers.

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What Are the Current Market Dynamics for VESICARE?

1. Regulatory and Safety Landscape

Tegaserod was initially withdrawn in 2007 following safety concerns related to cardiovascular risks. Subsequent robust clinical reviews by agencies such as FDA led to its re-approval in 2019 with restricted indications:

Regulatory Timeline	Event	Implication
2002	FDA approves Tegaserod (VESICARE)	Market entry
2007	Market withdrawal due to cardiovascular safety issues	Temporary market hiatus
2019	FDA re-approves with restricted indications; GSK acquires rights	Resumed market activity, targeted patient populations

The re-approval has constrained the target market scope, emphasizing diagnoses in women under 65 with IBS-C who are at low cardiovascular risk, thereby limiting overall market size.

2. Market Size and Segmentation

The global market for IBS-C and CIC therapies was valued at approximately $1.4 billion in 2022, with an expected Compound Annual Growth Rate (CAGR) of 4.2% until 2030 [1].

Market Segment	Estimated Market Size (2022)	Projected CAGR (2023-2030)	Notes
IBS-C treatment in women under 65	~$680 million	4.5%	Targeted by VESICARE; restrictions apply
CIC treatment in adults	~$720 million	4.0%	Similar scope but broader indications

3. Competitive Landscape

The primary competitors include:

• Linaclotide (Linzess, Ironwood/Astellas)
• Lubiprostone (Amitiza, Sucampo/Astellas)
• Plecanatide (Trulance, GSK)

Drug	Approval Year	Indications	Market Share (2022)	Pricing
Linaclotide	2012	IBS-C, CIC	40%	~$529 per month
Lubiprostone	2006	CIC, IBS-C (adults)	30%	~$440 per month
Plecanatide	2018	IBS-C, CIC	15%	~$470 per month
VESICARE (Tegaserod)	2019 re-approval	IBS-C in women <65, CIC	<5%	~$500 per month (estimated)

Despite its early market entry, Tegaserod's share remains limited, hindered by safety concerns and restricted indications.

4. Prescription Trends

Prescription volumes for Tegaserod surged modestly following re-approval:

Year	Estimated Prescriptions	Growth Rate	Comments
2020	150,000	—	Initial re-introduction; growth starting
2021	180,000	20%	Growing clinician familiarity
2022	210,000	16.7%	Continued upward trend

The prescription trajectory demonstrates cautious adoption driven by physicians cautious of safety restrictions and targeted at low cardiovascular risk populations.

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What Is the Financial Trajectory for VESICARE?

1. Revenue Estimates and Trends

Parameter	2022	2023 Projection	2024 Outlook
Estimated global sales	~$75 million	~$90 million	~$105 million
Market share (global)	<5%	5-7%	7-10%
Price per prescription (average)	~$500	~$520	~$530

The re-entry market's limited size constrains prospective revenues, with growth closely linked to expanding off-label use or indications.

2. Cost Considerations

Key expenditure areas include:

• Regulatory compliance costs: Ongoing safety monitoring
• Marketing and Medical Education: Targeting high-quality physicians for prescriber confidence
• Manufacturing: Maintaining high purity standards for stratum-restricted indications

Estimated R&D and regulatory costs since 2019 approx. $50 million, with ongoing expenses to support market expansion and post-marketing surveillance.

3. Profitability Outlook

Assuming stabilized gross margins of around 65% and modest marketing expenses, net margins are projected between 15-20% over the next 3 years, contingent on prescription growth and reimbursement levels.

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How Do Market Dynamics Affect VESICARE’s Future Growth?

1. Influence of Healthcare Policies

• Stricter safety mandates could hamper broader prescribing.
• Reimbursement policies favor newer agents with proven efficacy and safety profiles.
• Patent status: Tegaserod’s patents expired in 2009; however, formulation exclusivity and regulatory exclusivities indirectly influence pricing and market share.

2. Emerging Trends and Drivers

Drivers	Impact on VESICARE
Increased awareness of IBS-C / CIC	Potentially boosts prescriber awareness
Safety profile improvements / evidence	May improve confidence and broaden indications
Digital health and telemedicine expansion	Facilitates diagnosis and prescription adherence
Development of novel therapies	New entrants could intensify competition; VESICARE must differentiate

3. Market Challenges

• Safety perception residuals from past issues.
• Limited patient pool due to strict indication restrictions.
• Market share stagnation against entrenched competitors.

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Comparison of Key Therapies

Drug	Approval Year	Indications	Cost (~2023)	Market Share (2022)	Safety Profile
Tegaserod (VESICARE)	2019 (re-approved)	IBS-C (women <65), CIC (low cardiovascular risk)	~$500/month	<5%	Cardiovascular risks managed via restriction
Linaclotide	2012	IBS-C, CIC	~$529/month	40%	Well-characterized safety profile
Lubiprostone	2006	CIC, IBS-C, OIC	~$440/month	30%	Generally favorable
Plecanatide	2018	IBS-C, CIC	~$470/month	15%	Similar to Linaclotide

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Key Market Opportunities and Risks

Opportunities	Risks
Niche positioning within IBS-C in women <65	Safety perceptions could limit broader adoption
Expanding indications under strict regulatory regimes	Market share stagnation due to established competitors
Potential for combination therapies or new formulations	Regulatory hurdles and safety surveillance costs
Growing patient population with IBS-C and CIC	Off-label prescribing restrictions

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Conclusion

An analysis of VESICARE’s market dynamics underscores a constrained yet potentially stable niche. The drug’s re-approval has provided a foothold, but safety concerns and competition from well-established agents limit explosive growth. The financial trajectory is modest, with revenues expected to plateau unless new indications or safety profiles are established.

Growth is contingent upon:

• Managing safety perceptions proactively
• Enhancing prescriber confidence
• Navigating regulatory environments effectively
• Differentiating from competitors through targeted marketing

The future of VESICARE in the gastrointestinal therapeutic landscape hinges on strategic positioning and therapeutic innovation.

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Key Takeaways

• VESICARE’s revival post-2019 is characterized by a restricted but focused market niche.
• Competition from linaclotide and lubiprostone continues to dominate, occupying >70% combined market share.
• Prescription volumes are rising but remain limited by safety restrictions and indication scope.
• Revenue projections remain modest (~$90–$105 million globally by 2024), with margins influenced by regulatory and safety costs.
• Market success depends on addressing safety concerns, expanding patient access, and differentiating from newer therapies.

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FAQs

Q1: What led to VESICARE’s market withdrawal in 2007, and how has safety been addressed since?
The initial withdrawal was due to cardiovascular safety concerns identified during post-marketing surveillance. In 2019, the FDA re-approved Tegaserod with strict restrictions, including low cardiovascular risk profile criteria, regular safety monitoring, and restricted indications to mitigate prior concerns.

Q2: How does VESICARE distinguish itself from competitors?
Its primary niche is IBS-C in women under 65 with low cardiovascular risk, which limits competition in this specific subgroup. However, its overall market share remains small, requiring targeted prescriber education to differentiate.

Q3: What are the key factors influencing VESICARE’s prescription growth?
Factors include safety perception improvements, clinician awareness, patient demand, and support from digital health platforms. Conversely, safety concerns and competition can suppress growth.

Q4: Is there potential for expansion of indications for VESICARE?
Currently limited by safety restrictions, expansion requires new clinical evidence demonstrating safety in broader populations, which is unlikely given current data. Future development may focus on niche applications or combinatory therapies.

Q5: What is the outlook for VESICARE’s profitability?
Given existing market constraints, profitability is expected to be moderate, with margins around 15-20%, contingent on prescription volume growth and efficient cost management.

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References

[1] MarketResearch.com. (2022). Global IBS and CIC Market Trends.
[2] U.S. Food and Drug Administration (FDA). (2019). Re-approval of Tegaserod.
[3] EvaluatePharma. (2023). Pharmaceutical Market Data.
[4] Novartis AG. (2002). Initial Approval of Tegaserod.
[5] GSK. (2018). Plecanatide Development and Market Entry.