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:	2,287
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		DISCN	Yes	No
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518-002	Nov 19, 2004		DISCN	Yes	No
Astellas	VESICARE LS	solifenacin succinate	SUSPENSION;ORAL	209529-001	May 26, 2020		DISCN	Yes	No	9,918,970		Y

International Patents for VESICARE

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

Country	Patent Number	Title	Estimated Expiration
Austria	233761
Australia	4355396
Australia	695616
Canada	2208839	DERIVES DE QUINUCLIDINE ET COMPOSITION PHARMACEUTIQUE LES CONTENANT (QUINUCLIDINE DERIVATIVES AND MEDICINAL COMPOSITION THEREOF)
China	1045601
China	1171109
Germany	122004000048

Supplementary Protection Certificates for VESICARE

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	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
0801067	91133	Luxembourg		91133, EXPIRES: 20181118
0801067	CA 2004 00037	Denmark
0801067	SPC014/2004	Ireland		SPC014/2004: 20050803, EXPIRES: 20181215
0801067	C00801067/01	Switzerland		PRODUCT NAME: SOLIFENACIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57203 12.05.2006

VESICARE (solifenacin) market dynamics and financial trajectory: sales trends, share drivers, payer pressure, and long-horizon revenue outlook

Last updated: June 25, 2026

How has VESICARE (solifenacin) performed commercially and what are the key market dynamics?

VESICARE’s commercial trajectory is shaped by (1) mature overactive bladder (OAB) demand, (2) intense competitive substitution inside the antimuscarinic class and against newer OAB mechanisms, and (3) long-term patent and exclusivity erosion that drives generic entry economics.

Market structure that affects revenue

• OAB is a chronic condition with ongoing treatment, but the category is segmented by patient tolerance and formulary placement rather than clinical breakthrough cycles.
• Antimuscarinics face ongoing payer scrutiny tied to safety, cognitive risk perception, and step edits, which narrows premium pricing runway over time.
• Generic penetration compresses ASPs once exclusivity ends; net revenue becomes more sensitive to volume, channel mix, and rebates rather than brand pricing.

Competitive forces

• Antimuscarinic class competition: VESICARE competes with other oral agents used for OAB, including tolterodine (IR/ER), oxybutynin (including ER/transdermal), fesoterodine, darifenacin, and trospium.
• β3-adrenergic agonist competition: mirabegron and vibegron pressure antimuscarinic share through tolerability and cognitive risk considerations.
• Combination therapy and sequencing: clinicians increasingly sequence from antimuscarinics to β3 agonists and/or combine, which reduces addressable share for any single antimuscarinic at steady state.

What this means for financial trajectory

• Brand growth is typically front-loaded when exclusivity is intact.
• After generic approvals, VESICARE’s revenue shifts from brand economics to limited brand premium, retention among higher-performing prescribers, and any residual differentiation from dosing and tolerability patterns.

What is VESICARE’s payer and formulary profile and how does it impact pricing and net sales?

OAB formularies commonly implement step therapy and prior authorization for agents with perceived safety issues, especially in older patients. That framework affects net-to-gross through rebate design and placement tiering.

Key formulary levers

• Step edits: payers often require trials of older, cheaper antimuscarinics before covering higher-cost agents.
• Safety and tolerability positioning: anticholinergic burden drives utilization management for high-risk populations.
• Plan-specific substitution: once generics establish broad coverage, VESICARE’s ability to maintain formulary status depends on contracts and rebates, not on clinical differentiation alone.

Revenue implication

• Long-run net sales generally track the ability to retain preferred status versus competing generics and to defend against β3 agonist adoption in newer cohorts.

When does VESICARE lose exclusivity and what generic entry risks exist?

A precise exclusivity and patent-by-patent timeline requires Orange Book and patent-list records for VESICARE’s specific NDA product and strength(s). Without those records in-hand, a complete expiration and generic risk assessment cannot be rendered to a litigation-grade standard.

What Orange Book status applies to VESICARE and how many patents are listed?

A precise Orange Book status requires the current FDA Orange Book listings for the exact VESICARE NDA/strength and the associated patent families. Without the Orange Book data, the number of listed patents, their claims, and their expiration/trigger dates cannot be stated accurately.

How do patent expirations affect revenue vs. how do generics affect margins?

Once exclusivity ends, market outcomes for solifenacin brands typically shift to:

• Volume erosion from AB-rated generics
• Net price compression through contract rebates and competitive ASP declines
• Reduced marketing efficiency as share gain becomes harder without a differentiated mechanism

Financial mechanism

• In brand years, revenue is driven by a mix of price and volume retention.
• After generic entry, revenue becomes volume-dependent while margin is driven by channel contracts, rebates, and product mix. Even if gross revenue stabilizes temporarily, net revenue per unit usually declines.

How does VESICARE compare with mirabegron (and vibegron) on market share dynamics?

Even without prescribing-level metrics, the economic pattern is consistent across OAB:

• β3 agonists win in certain patient profiles where tolerability and cognitive risk drive preference.
• Antimuscarinics remain relevant where formularies keep them on lower-cost tiers or where patients have already tolerated them.

Category-level impact on VESICARE

• As β3 usage grows, antimuscarinic share tends to erode at the margin.
• Brand antimuscarinics tend to face the double squeeze: generic substitution within-class plus mechanism substitution to β3 agents.

What manufacturing and supply factors influence VESICARE’s availability and financial stability?

For oral solids like solifenacin, manufacturing risks typically influence revenue mainly through:

• Supply continuity that protects loyal prescriber and distributor contracts.
• Regulatory compliance that affects ability to ship across channel partners.
• Cost of goods that changes as scale and supplier competition evolve post-generic entry.

Without plant- and batch-specific regulatory records, only high-level dynamics can be stated: in mature products, supply stability generally becomes a cost-and-service issue rather than a clinical differentiation driver.

What product lifecycle factors drive VESICARE’s long-term outlook?

Lifecycle drivers

• Mature indication: OAB treatment has stable patient demand, but switching is frequent when plan coverage changes.
• R&D pipeline substitution: newer OAB mechanisms can shift new starts away from antimuscarinics over time.
• Prescriber habits: once generics dominate, prescriber choices converge toward covered options.

Long-horizon expectation

• Brand revenues tend toward plateau then decline once brand-only economics are eroded.
• Residual branded performance depends on remaining payer differentiation, distributor contracts, and any continuing differentiation not captured in price alone.

Key financial trajectory summary for VESICARE

A quantified revenue or sales trajectory cannot be responsibly stated here without specific financial datasets (company filings, audited sales by geography, and brand net sales history). To map the trajectory credibly, the required inputs are:

• historical brand net sales by year,
• ASP trends and generic adoption rates,
• geography mix,
• rebate and payer coverage evolution.

Because those primary data are not included in the source set available to this response, only directional market dynamics and revenue drivers can be provided.

Key Takeaways

• VESICARE’s commercial dynamics are dominated by mature OAB demand combined with substitution pressure from both in-class antimuscarinic generics and β3 agonists.
• After exclusivity erosion, VESICARE revenue becomes more sensitive to volume retention and net price compression than to brand pricing.
• Payer formularies and utilization management materially shape net sales through tier placement, step therapy, and safety-related coverage rules.
• A litigation-grade exclusivity and generic entry assessment requires VESICARE’s exact Orange Book listing and patent table, which is not provided here.

FAQs

1. How do antimuscarinic step edits affect solifenacin prescribing in Medicare Part D formularies?
2. What is the typical net price impact for antimuscarinic brands after AB-rated generic entry?
3. Do β3 agonists reduce persistence rates for antimuscarinic OAB therapy, and how does that change brand revenues?
4. How do regional payer contracts influence solifenacin branded vs generic uptake?
5. What channel-mix changes (retail vs mail order) most affect solifenacin net sales post-genericization?

References

No sources were cited because no Orange Book, FDA labeling, or historical sales/financial datasets were included in the provided material.

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