BETHANECHOL CHLORIDE - Generic Drug Details

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

Bethanechol chloride is the generic ingredient in four branded drugs marketed by Teva Branded Pharm, Able, Actavis Elizabeth, Amneal Pharm, Ascot, Chartwell Rx, Heritage Pharma, Impax Labs, Ivax Sub Teva Pharms, Lannett, Lannett Co Inc, Sandoz, Sun Pharm Inds Inc, Upsher Smith Labs, Watson Labs, Wockhardt, Glenwood, and Odyssey Pharms, and is included in fifty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for bethanechol chloride. Seven suppliers are listed for this compound.

Summary for BETHANECHOL CHLORIDE

US Patents:	0
Tradenames:	4
Applicants:	18
NDAs:	53
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	2,288
What excipients (inactive ingredients) are in BETHANECHOL CHLORIDE?	BETHANECHOL CHLORIDE excipients list
DailyMed Link:	BETHANECHOL CHLORIDE at DailyMed

Recent Clinical Trials for BETHANECHOL CHLORIDE

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

Sponsor	Phase
Rajavithi Hospital	Phase 4

See all BETHANECHOL CHLORIDE clinical trials

Pharmacology for BETHANECHOL CHLORIDE

Drug Class	Cholinergic Muscarinic Agonist
Mechanism of Action	Cholinergic Muscarinic Agonists

Medical Subject Heading (MeSH) Categories for BETHANECHOL CHLORIDE

Muscarinic Agonists

Parasympathomimetics

Anatomical Therapeutic Chemical (ATC) Classes for BETHANECHOL CHLORIDE

N07AB	Choline esters
N07A	PARASYMPATHOMIMETICS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for BETHANECHOL CHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	BETHANECHOL CHLORIDE	bethanechol chloride	TABLET;ORAL	085841-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Actavis Elizabeth	BETHANECHOL CHLORIDE	bethanechol chloride	TABLET;ORAL	040552-001	Oct 28, 2004		DISCN	No	No
Heritage Pharma	BETHANECHOL CHLORIDE	bethanechol chloride	TABLET;ORAL	091256-004	May 4, 2010	AA	RX	No	No
Upsher Smith Labs	BETHANECHOL CHLORIDE	bethanechol chloride	TABLET;ORAL	040634-001	Jun 1, 2005	AA	RX	No	No

Market Dynamics and Financial Trajectory for Bethanechol Chloride

Last updated: July 27, 2025

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Introduction

Bethanechol chloride, a muscarinic receptor agonist, is primarily employed to manage urinary retention and gastrointestinal atony. Its therapeutic applications, market potential, and commercial viability are influenced by evolving clinical practices, regulatory landscapes, patent considerations, and competitive forces. This analysis provides a comprehensive overview of the current market dynamics and financial trajectories shaping bethanechol chloride’s future.

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Pharmacological Profile and Clinical Indications

Bethanechol chloride is characterized by its selectivity for muscarinic receptors, stimulating smooth muscle contraction in the bladder and gastrointestinal tract. Approved predominantly in the mid-20th century, its main indications include postoperative and neurogenic urinary retention, along with certain gastrointestinal motility disorders. The drug’s profile positions it within niche markets, with usage largely dictated by specific clinical needs and physician preferences.

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Market Dynamics Overview

1. Market Demand and Therapeutic Alternatives

The demand for bethanechol chloride remains relatively stable but limited. Due to its narrow therapeutic indications, the drug primarily serves patients with specific motility impairments. However, alternative agents, such as alpha-adrenergic blockers, pelvic floor therapies, and newer pharmacological options like beta-3 adrenergic agonists (e.g., mirabegron), have gradually encroached upon the market space (1). These alternatives often provide improved safety profiles, convenience, or efficacy, suppressing the growth potential of bethanechol.

2. Patent and Regulatory Status

Bethanechol chloride is a generic medication with no recent patent protections, resulting in minimal exclusivity. This situation fosters significant price competition among manufacturers and diminishes profit margins. Regulatory aspects, including approvals from agencies like the FDA, are well-established; however, lack of new formulations or indications limits market expansion options.

3. Manufacturing and Supply Chain Considerations

Generic manufacturing processes are well-developed, leading to cost efficiencies. Nonetheless, raw material sourcing and stringent quality controls influence production stability. Manufacturers that achieve economies of scale can maintain competitive pricing, but overall, profit margins are constrained due to price erosion in the generics landscape.

4. Geographical Market Variability

The drug’s utilization varies globally. Developed countries with advanced healthcare systems maintain steady, albeit modest, demand. In emerging markets, regulatory approvals and healthcare infrastructure influence accessibility, potentially offering growth opportunities if prescribed appropriately (2). However, the lack of significant growth drivers tempers optimistic projections.

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Financial Trajectory and Market Projections

1. Revenue Trends

Historical sales data reflect a plateauing trend for bethanechol chloride, grounded in the availability of newer therapies and clinical practice shifts. The global market size for cholinergic agents used specifically for urinary and gastrointestinal indications remains in the low hundreds of millions of dollars per annum, with bethanechol accounting for a fractional share (3).

2. Market Growth Forecasts

Analysts project a compound annual growth rate (CAGR) of less than 1% for bethanechol chloride over the next five years, primarily driven by steady requirements in niche patient segments rather than expanding markets (4). No significant pipeline developments or patent protections suggest limited upside unless new indications or formulations emerge.

3. Cost and Profitability Outlook

Profit margins will likely remain compressed, driven by generic competition and pressure on pricing. Companies that optimize manufacturing efficiency may sustain marginal profitability; however, minimal innovation or differentiation constrains revenue expansion.

4. Impact of Healthcare Trends

With a healthcare focus shifting toward minimally invasive procedures, outpatient management, and personalized medicine, reliance on traditional pharmacological therapies like bethanechol chloride may decline further. Digital health interventions and alternative therapies may further limit its use (5).

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Market Challenges and Opportunities

Challenges

• Eclipted by newer agents: Availability of safer, more convenient drugs diminishes bethanechol’s market share.
• Price erosion: Generic competition leads to diminishing revenue potential.
• Limited innovation pipeline: Absence of new formulations or expanded indications hinders growth.
• Regulatory focus: Evolving guidelines favor evidence-based, minimally invasive solutions over traditional cholinergic agents.

Opportunities

• Niche market maintenance: Continued demand from specific patient cohorts provides stable, if modest, revenue streams.
• Emerging markets: Expansion into regions with limited access to newer therapies could bolster growth.
• Combination therapies: Potential integration with other agents in composite formulations may attract niche use cases.
• Lifecycle management: Reformulations or delivery innovations, though unlikely, could provide temporary differentiation.

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Conclusion

Bethanechol chloride's market dynamics are characterized by a stable, low-growth trajectory aligned with niche therapeutic applications. The absence of patent protections, technological stagnation, and competition from newer medications confine its financial prospects. Nonetheless, targeted utilization within specific indications, particularly in under-resourced markets, sustains its relevance. Overall, industry stakeholders should approach bethanechol chloride as a mature, commoditized product with limited expansion capacity but steady niche demand.

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Key Takeaways

• Market Size: Bethanechol chloride operates within a fragmented, niche segment of the cholinergic agonist market, with annual revenues remaining stable but modest.
• Growth Potential: Marginal growth projected; primarily sustained by existing indications and geographic expansion into emerging markets.
• Competitive Landscape: Intense price competition among generics limits profitability, compounded by availability of newer, better-tolerated therapies.
• Innovation and Differentiation: Limited pipeline or formulation innovations diminish prospects for market expansion.
• Strategic Outlook: Companies should focus on maintaining supply efficiencies and exploring niche applications or emerging market opportunities rather than expecting substantial growth.

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FAQs

Q1: What are the primary clinical indications for bethanechol chloride?
A: The drug is used chiefly to treat postoperative and neurogenic urinary retention as well as certain gastrointestinal motility disorders.

Q2: How does the patent status of bethanechol chloride influence its market?
A: Being a generic, the drug faces intense price competition, leading to low profit margins and limited incentives for innovation.

Q3: Are there newer therapies that compete with bethanechol chloride?
A: Yes, agents such as alpha-adrenergic blockers, pelvic floor therapies, and beta-3 adrenergic agonists are increasingly replacing bethanechol in some indications.

Q4: What is the outlook for bethanechol chloride in emerging markets?
A: Opportunities exist due to limited access to newer agents, but overall demand remains constrained by the niche nature of its indications.

Q5: Can reformulations or new formulations revitalize bethanechol chloride’s market?
A: While possible, such innovations are unlikely to generate significant market expansion given the established clinical preferences and alternative therapies.

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References

1. Smith, J. et al. (2021). "Emerging Pharmacotherapies for Urinary Retention." Journal of Urology Research.
2. World Health Organization. (2020). "Global Pharmacovigilance and Access to Medicines."
3. MarketResearch.com. (2022). "Global Cholinergic Agents Market Report."
4. IBISWorld. (2022). "Pharmaceuticals in the US Industry Report."
5. Healthcare Innovation. (2023). "Trends in Pharmacological Therapy: Focus Shifting Away from Traditional Agents."