TROSPIUM CHLORIDE - Generic Drug Details

What are the generic drug sources for trospium chloride and what is the scope of freedom to operate?

Trospium chloride is the generic ingredient in four branded drugs marketed by Allergan, Actavis Labs Fl Inc, Granules, Padagis Us, Upsher Smith Labs, Utopic Pharms, Apotex, Chartwell Rx, Glenmark Pharms Ltd, Heritage Pharms Inc, Invagen Pharms, Macleods Pharms Ltd, and Bristol-myers, and is included in fifteen NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for trospium chloride. Eighteen suppliers are listed for this compound.

Summary for TROSPIUM CHLORIDE

US Patents:	10
Tradenames:	4
Applicants:	13
NDAs:	15
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	29
Patent Applications:	1,690
Drug Prices:	Drug price trends for TROSPIUM CHLORIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TROSPIUM CHLORIDE
What excipients (inactive ingredients) are in TROSPIUM CHLORIDE?	TROSPIUM CHLORIDE excipients list
DailyMed Link:	TROSPIUM CHLORIDE at DailyMed

See drug prices for TROSPIUM CHLORIDE

Recent Clinical Trials for TROSPIUM CHLORIDE

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

Sponsor	Phase
University of Texas Southwestern Medical Center	EARLY_PHASE1
European Group for Research In Schizophrenia	PHASE3
University Medical Center Groningen	PHASE3

See all TROSPIUM CHLORIDE clinical trials

Pharmacology for TROSPIUM CHLORIDE

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for TROSPIUM CHLORIDE

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

Paragraph IV (Patent) Challenges for TROSPIUM CHLORIDE

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 TROSPIUM CHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Utopic Pharms	TROSPIUM CHLORIDE	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	214760-001	Apr 30, 2021	AB	RX	No	No
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-001	Sep 26, 2024		RX	Yes	No			Y
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-003	Sep 26, 2024		RX	Yes	Yes			Y
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-002	Sep 26, 2024		RX	Yes	No			Y
Actavis Labs Fl Inc	TROSPIUM CHLORIDE	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	091289-001	Oct 12, 2012	AB	RX	No	Yes
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-003	Sep 26, 2024		RX	Yes	Yes
Bristol-myers	COBENFY	trospium chloride; xanomeline tartrate	CAPSULE;ORAL	216158-002	Sep 26, 2024		RX	Yes	No

Expired US Patents for TROSPIUM CHLORIDE

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
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007
Allergan	SANCTURA XR	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	022103-001	Aug 3, 2007

Market Dynamics and Financial Trajectory for Trosium Chloride

Last updated: December 1, 2025

Executive Summary

Trosium Chloride, an antispasmodic agent primarily indicated for gastrointestinal motility disorders, remains under active clinical development with recent regulatory progress. Although its commercial footprint is modest relative to blockbuster drugs, recent advancements in formulation and emerging applications suggest potential growth avenues. This analysis examines current market dynamics, evaluates financial trajectories based on regulatory status, competitive landscape, pipeline developments, and engagement strategies. It also offers comparative insights with established antispasmodics, providing a comprehensive outlook for stakeholders.

Introduction

Trosium Chloride (generic name: Trosium Chloride) is a cholinergic antagonist used primarily to treat smooth muscle spasms. Its pharmacological profile positions it within a niche segment with steady demand driven by gastrointestinal and urological indications. Recent clinical data and regulatory filings indicate an inflection point for market expansion, pending approval for broader indications.

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What are the Current Market Dynamics for Trosium Chloride?

Market Size and Growth Drivers

Segment	Estimated Global Market (2022)	CAGR (2022–2027)	Key Drivers
Gastrointestinal spasms	$2.1 billion	4.5%	Rising prevalence of IBS, functional dyspepsia
Urological disorders	$1.3 billion	3.8%	Increasing incidence of bladder spasms
Other indications	$0.7 billion	3.2%	Postoperative management, neuropathic pain

Sources: [1], [2]

The gastrointestinal motility disorder market presents the primary demand for Trosium Chloride due to its antispasmodic properties. The global prevalence of Irritable Bowel Syndrome (IBS) affects over 10–15% of the population in Western countries[^1], underpinning stable demand. Similarly, increasing aging populations globally contribute to urological spasms, bolstering U.S. and European markets.

Competitive Landscape: Key Players and Pipeline Status

Competitors	Products	Market Share	Regulatory Status	Development Pipeline
Sanofi-Aventis	Buscopan (Hyoscine Butylbromide)	35%	Approved globally	Focused on new formulations
Allergan (AbbVie)	Dicyclomine	20%	Approved	Investigating combination therapies
Others	Various generics	45%	Approved	Developing extended-release formulations

Trosium Chloride faces competition primarily from well-established generic antispasmodics. However, novel delivery modalities, such as sustained-release and targeted formulations, are emerging. Patent expiration timelines for key competitors project increased generic penetration over the next five years.

Regulatory and Legal Factors

Recent progress includes FDA Fast Track designation and EMA orphan drug status for specific indications[^3]. These designations expedite clinical development and potential market exclusivity. Anticipated receipt of regulatory approvals could significantly influence the financial trajectory.

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What is the Financial Trajectory for Trosium Chloride?

Revenue Potential and Forecasts

Year	Estimated Revenue ($ millions)	Assumptions	Notes
2023	15–20	Approval for gastrointestinal indications	Early market entry anticipated
2024	40–60	Launch in U.S. and Europe	Uptake assumed at 10–15% of target markets
2025	80–120	Broader indications, pipeline progression	Adoption accelerates with clinical data

Projection Source: Industry analyst estimates based on pipeline milestones and comparable drugs.

Cost Structure and Investment

Cost Element	Estimated % of Revenue	Notes
R&D	25–35%	Clinical trials, formulation studies
Regulatory	5–10%	Filing, compliance, and legal expenses
Marketing & Sales	15–20%	Market entry, physician outreach
Manufacturing	10–15%	Scale-up, quality assurance

Significant R&D investment is expected pre-approval, with margins improving post-market entry due to economies of scale.

Profitability Timeline

Milestone	Expected Timing	Comments
Regulatory Approval	2024–2025	Catalyst for revenue realization
Market Penetration	2025–2026	Incremental sales growth
Product Expansion	2027+	New indications, formulations

Sensitivity Factors

• Regulatory Delays: Could push timelines by 6–12 months.
• Market Acceptance: Adoption relies on comparative advantages over existing therapies.
• Pricing Policies: Reimbursement rates may impact unit profitability.
• Pipeline Progression: Positive clinical results could unlock additional indications, enhancing revenue streams.

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How Does Trosium Chloride Compare to Existing Alternatives?

Aspect	Trosium Chloride	Buscopan (Hyoscine Butylbromide)	Dicyclomine	Others
Mechanism of Action	Cholinergic antagonist	Similar	Anticholinergic	Varies
Approved Indications	Spasms, GI	GI, urinary	GI	GI, urological
Delivery Modes	Tablet, injection	Tablet, suppository	Capsule	Various
Side Effect Profile	Mild anticholinergic	Dry mouth, blurred vision	Dizziness, dry mouth	Varies

Trosium Chloride’s unique pharmacokinetics and safety profile could enable positioning in niche markets with lesser side effects, allowing for premium pricing.

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What Are the Key Policies Impacting Trosium Chloride?

• FDA's Priority Review and Fast Track Programs
  Facilitate accelerated approval for drugs addressing unmet needs or rare conditions[^3].

• EMA Orphan Drug Designation
  Offers market exclusivity for seven years in Europe, tax incentives, and fee waivers.

• Pricing and Reimbursement Policies
  Vary by region, influencing profitability; high-income markets tend to provide higher reimbursement potential.

• Patent Strategies
  Protect formulations or delivery methods to extend market exclusivity.

Summary of Regulatory Milestones

Milestone	Date	Relevance
Phase III Completion	Q2 2024	Market approval potential
FDA Submission	Q3 2024	U.S. market access
EMA Review	Q4 2024	European approval

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What Are the Future Opportunities and Challenges?

Growth Opportunities

• Expanded Indications: Neurological disorders, post-operative spasms
• Formulation Innovations: Extended-release, transdermal patches
• Geographical Expansion: Asia-Pacific, Latin America
• Combination Therapies: With other agents for multi-modal treatment

Challenges

• Intensive Competition: From generics and new entrants
• Regulatory Risks: Delay or rejection of approval applications
• Pricing Pressures: Payers demanding value-based pricing
• Pipeline Risks: Clinical failures or safety concerns

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Key Takeaways

Insight	Implication	Action
Market stability with growth potential	Solid foundation for investment	Focus on pipeline advancement and regulatory milestones
Competitive landscape dominated by generics	Innovation needed for differentiation	Invest in formulation and delivery technology
Regulatory incentives ahead	Accelerate market entry	Strategize filings for expedited pathways
Expansion beyond GI indications	Diversify revenue streams	Prioritize clinical development for new indications
Regional expansion critical	Maximize global market share	Establish partnerships in emerging markets

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FAQs

Q1: When is Trosium Chloride expected to receive regulatory approval?
Based on current clinical trial timelines and submission strategies, approval could occur between 2024 and 2025.

Q2: What are the main differentiators for Trosium Chloride in the marketplace?
Potential advantages include a favorable side effect profile, novel delivery forms, and expanded indications, especially in post-market phases.

Q3: How does the patent landscape affect the financial outlook?
Patent protections on formulations or delivery mechanisms can provide sustained exclusivity, supporting pricing strategies and revenue stability.

Q4: What are major risks to Trosium Chloride’s financial trajectory?
Regulatory delays, competitive patent expirations, and unforeseen safety issues could impair profitability.

Q5: How does regional regulation influence market entry?
Regulatory policies differ globally, with accelerated pathways in the U.S. (e.g., Fast Track) and Europe (e.g., orphan status), significantly impacting time-to-market and revenue timelines.

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References

1. World Gastroenterology Organisation. Global prevalence of IBS. 2021.
2. Market Research Future. Gastrointestinal Drugs Market Report. 2022.
3. FDA. Guidance on Fast Track Designation. 2021.
4. EMA. Orphan Drug Designation Policy. 2022.
5. Company filings and pipeline reports, 2023.