SANCTURA XR Drug Patent Profile

Which patents cover Sanctura Xr, and when can generic versions of Sanctura Xr launch?

Sanctura Xr is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in SANCTURA XR is trospium chloride. There are sixteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the trospium chloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sanctura Xr

A generic version of SANCTURA XR was approved as trospium chloride by GLENMARK PHARMS LTD on August 13^th, 2010.

Summary for SANCTURA XR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	8
Patent Applications:	1,040
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SANCTURA XR
DailyMed Link:	SANCTURA XR at DailyMed

Recent Clinical Trials for SANCTURA XR

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

Sponsor	Phase
Neil M. Resnick	Phase 4
National Institute on Aging (NIA)	Phase 4
Karuna Therapeutics	Phase 1

See all SANCTURA XR clinical trials

Paragraph IV (Patent) Challenges for SANCTURA XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SANCTURA XR	Extended-release Capsules	trospium chloride	60 mg	022103	1	2009-03-02

US Patents and Regulatory Information for SANCTURA XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007		DISCN	Yes	No

Expired US Patents for SANCTURA XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007	7,410,978
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007	7,781,448
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007	7,781,449
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007	7,763,635
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007	7,759,359

International Patents for SANCTURA XR

See the table below for patents covering SANCTURA XR around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005046684
Japan	5610663
Austria	493981
Japan	5783489
Spain	2359375

Market Dynamics and Financial Trajectory for SANCTURA XR

Last updated: July 29, 2025

---

Introduction

SANCTURA XR (trospium chloride extended-release capsules) is a prescription medication driven by its primary indication for the treatment of overactive bladder (OAB). Approved by the U.S. Food and Drug Administration (FDA) in 2007, SANCTURA XR represents a significant development within anticholinergic therapy, distinguished by its extended-release formulation aimed at improving patient compliance and reducing side effects associated with traditional formulations. This analysis explores the market environment, competitive landscape, financial performance, and future outlook of SANCTURA XR, providing insights essential to stakeholders involved in licensing, investment, and strategic planning.

---

Market Overview and Dynamics

Prevalence and Demographic Trends

The global overactive bladder market is expanding, driven by an aging population and increased awareness of bladder health. The National Overactive Bladder Assessment (NOBLE) indicates that approximately 33 million adults in the United States suffer from OAB, with prevalence increasing with age—primarily affecting individuals over 65 years old. As the population ages, healthcare providers are incentivized to adopt therapies that effectively manage symptoms while minimizing adverse effects.

Therapeutic Landscape

SANCTURA XR competes within a crowded class of anticholinergic agents, with primary rivals including oxybutynin, tolterodine, solifenacin, darifenacin, and mirabegron. The latter, a β3 adrenergic agonist, offers an alternative mechanism of action, often favored for its tolerability profile. Despite competition, SANCTURA XR’s distinct extended-release (ER) formulation offers advantages such as improved compliance and reduced dosing frequency.

Market Penetration and Adoption

The extended-release formulation has facilitated broader adoption, especially among elderly patients who are sensitive to side effects like dry mouth and cognitive impairment. The shift toward minimally invasive treatments has bolstered SANCTURA XR’s market share, particularly in specialty urology and gynecology practices. However, physician preference varies based on side effect profiles, insurance coverage, and familiarity with the etiology and management of OAB.

---

Competitive Landscape and Market Share

Positioning of SANCTURA XR

SANCTURA XR's unique selling proposition centers on its mechanism as a selective muscarinic receptor antagonist, providing symptom relief with a favorable side effect profile. Its once-daily dosing enhances adherence compared to immediate-release formulations, which typically require multiple daily doses.

Market Share Dynamics

According to recent market research, SANCTURA XR accounts for approximately 8-12% of the U.S. prescription anticholinergic OAB market, competing primarily with tolterodine ER and solifenacin. The adoption rate is influenced by formulary inclusion, drug efficacy perceptions, and marketing efforts. Given the corticostriatal interplay in OAB management, SANCTURA XR’s market share remains competitive but susceptible to fluctuations driven by emerging therapies and innovation.

Impact of New Entrants and Therapies

Emerging therapies, notably β3 adrenergic agonists like mirabegron (Myrbetriq), have captured a growing segment due to better tolerability. Additionally, the development pipeline includes non-pharmacologic interventions, neuromodulation, and combination therapies, potentially constraining SANCTURA XR's market expansion.

---

Financial Trajectory

Revenue Performance

Since its launch, SANCTURA XR has demonstrated stable revenue streams, though growth trajectory has plateaued in recent years. The drug's sales are influenced by factors such as patent exclusivity, competitive pricing, and payer coverage.

In 2021, estimated U.S. sales of SANCTURA XR hovered around $120 million, marking a modest increase from previous years, supported by expanded formularies and increasing awareness among physicians treating OAB.

Pricing Strategy and Reimbursement

SANCTURA XR’s premium positioning reflects its extended-release benefits. The price per capsule averages around $4–$5, with insurance coverage largely dictated by formulary negotiations. Generic competitors, notably immediate-release trospium, begin to pressure pricing margins, although patent protections on SANCTURA XR delay significant generic penetration.

Reimbursement policies favor drugs with demonstrated adherence and tolerability, positioning SANCTURA XR advantageously against less tolerable alternatives. Payer negotiations and formulary placements heavily influence revenue potential.

Cost Structure and Profitability

Manufacturing costs are relatively stable, given the mature production process. Marketing and distribution constitute significant expense components, particularly as Novartis (owner of SANCTURA XR) invests in physician education and patient awareness initiatives. Gross margins are estimated at 65–70%, with profitability maintained through efficient supply chain management and strategic market positioning.

---

Regulatory and Patent Outlook

Sanctura XR’s patent protections are set to expire around 2027, opening avenues for generic competition that could significantly impact revenue streams. Nonetheless, formulation-specific patents for extended-release mechanisms may extend exclusivity, providing some market protection.

Regulatory developments, such as the approval of new delivery systems or combination written therapies, could influence SANCTURA XR's market positioning. Continued post-marketing surveillance affirms a favorable safety profile, supporting ongoing prescriptions.

---

Future Outlook and Growth Potential

Market Expansion in Emerging Regions

Global expansion remains challenging due to varying healthcare infrastructures and regulatory environments. However, emerging markets with aging populations, such as China and India, present growth opportunities, contingent on local regulatory approvals and pricing strategies.

Innovative Formulations and Combination Therapies

Research into combination therapies involving SANCTURA XR and other agents, such as β3 agonists, aims to optimize efficacy and tolerability. Development of biosimilars or reformulations with enhanced adherence features could further extend the drug’s lifecycle.

Impact of Biosimilar and Generic Competition

Patents expiring in 2027 could precipitate a wave of generics, exerting downward pressure on prices and revenues. Strategic planning must consider potential loss of exclusivity and the evolution of market share accordingly.

---

Key Takeaways

• Robust Market Need: The prevalence of overactive bladder continues to grow, underpinning steady demand for effective therapeutic options like SANCTURA XR.
• Competitive Positioning: SANCTURA XR’s once-daily dosing and tolerability confer advantages but face stiff competition from newer agents and generics.
• Revenue Stability: The product’s financial trajectory remains positive, supported by brand loyalty, formulary placements, and a favorable safety profile, though patent expiration poses a notable risk.
• Strategic Growth Drivers: Opportunities lie in geographic expansion, combination therapies, and formulation innovations, with the caveat of impending patent cliffs.
• Market Challenges: Competition from emerging therapies and potential generics necessitate proactive lifecycle management to sustain revenue.

---

FAQs

Q1: When is SANCTURA XR expected to face significant generic competition?
A: Patent protections are projected to expire around 2027, after which generic trospium formulations are likely to enter the market, increasing price competition and reducing revenues.

Q2: How does SANCTURA XR compare with mirabegron in terms of efficacy and tolerability?
A: While both are approved for OAB, SANCTURA XR’s anticholinergic profile is associated with side effects like dry mouth but generally effective. Mirabegron, as a β3 agonist, tends to have a more favorable tolerability profile, especially regarding cognitive and dry mouth effects.

Q3: What are the primary factors influencing SANCTURA XR’s market share?
A: Formulary placement, physician prescribing habits, patient adherence, insurance coverage, and competition from alternative therapies chiefly influence its share.

Q4: Are there ongoing clinical trials related to SANCTURA XR?
A: As of now, SANCTURA XR does not have significant ongoing clinical trials; however, research into new formulations and combination therapies may influence its future application.

Q5: What strategies can extend SANCTURA XR's market longevity?
A: Developing combination therapies, launching new formulations, expanding into emerging markets, and securing additional patents or exclusivities can help prolong its market presence.

---

Conclusion

SANCTURA XR's market dynamics reflect a mature but evolving landscape for overactive bladder therapies. Its extended-release formulation offers clinical and adherence advantages, supporting stable revenue streams. However, patent expiration, the emergence of new therapeutic classes, and generic competition present challenges that necessitate strategic planning. By leveraging its strengths and exploring innovation opportunities, SANCTURA XR can maintain relevance within the shifting paradigm of OAB management.

---

Sources:

[1] IQVIA. "U.S. Prescription Drug Market Data," 2022.
[2] FDA. "Sanctura (trospium chloride) Extended-Release Capsules Approval Letter," 2007.
[3] MarketsandMarkets. "Overactive Bladder Market by Drug Class and Region," 2022.
[4] EvaluatePharma. "Top Selling Drugs," 2022.
[5] Novartis. "SANCTURA XR Prescribing Information," 2022.