Generic METHANTHELINE BROMIDE INN equivalents, pharmaceutical patent expiration information and freedom to operate

Sponsor	Phase
University Medicine Greifswald	Phase 1
RIEMSER Arzneimittel GmbH	Phase 1

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shire	BANTHINE	methantheline bromide	TABLET;ORAL	007390-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: February 19, 2026

METHANTHELINE BROMIDE, a quaternary ammonium compound with anticholinergic properties, exhibits a niche market driven by specific therapeutic applications, primarily in gastrointestinal disorders. Its financial trajectory is influenced by factors including patent status, generic competition, and evolving treatment paradigms.

What is Methanthelene Bromide and its Primary Therapeutic Uses?

Methanthelene bromide, chemically known as N,N,N-trimethyl-2-[(2-methylphenyl)phenoxy]-1-propanaminium bromide, is an antimuscarinic agent. Its mechanism of action involves blocking the action of acetylcholine at muscarinic receptors, leading to reduced parasympathetic tone.

The primary therapeutic indication for methanthelene bromide has historically been the treatment of peptic ulcers and other gastrointestinal conditions characterized by excessive gastric motility and secretion. It functions by:

Reducing gastric acid secretion: By inhibiting vagal stimulation of parietal cells.
Decreasing gastrointestinal motility: This can alleviate symptoms associated with conditions like irritable bowel syndrome (IBS) and hypermotility disorders.
Reducing esophageal and duodenal spasm: Providing symptomatic relief in certain GI conditions.

While its use in peptic ulcer disease has largely been superseded by proton pump inhibitors (PPIs) and H2 receptor antagonists due to superior efficacy and safety profiles, methanthelene bromide may still find application in select cases or as an adjunct therapy where its specific anticholinergic effects are deemed beneficial.

What is the Current Patent Landscape for Methanthelene Bromide?

The original patents covering the synthesis and use of methanthelene bromide have long expired. The compound was first patented in the mid-20th century. Consequently, methanthelene bromide is available as a generic medication.

Exclusivity Period: The period of market exclusivity afforded by the original patents has concluded.
Generic Availability: Multiple pharmaceutical manufacturers produce and market generic versions of methanthelene bromide.
New Patent Filings: There are no significant recent patent filings suggesting novel formulations, delivery systems, or new therapeutic indications for methanthelene bromide that would confer substantial market exclusivity or create new revenue streams for a single entity. Research in this area has largely focused on more advanced drug classes.

Who are the Key Manufacturers and Market Participants?

Due to the expiration of its original patents, methanthelene bromide is produced by a range of generic pharmaceutical manufacturers. The market is characterized by a fragmented landscape rather than dominance by a few key innovators.

Major generic manufacturers that may produce or have produced methanthelene bromide include:

Endo Pharmaceuticals (historically, through acquisitions or past product lines)
Teva Pharmaceuticals
Sandoz (Novartis)
Mylan (now Viatris)
Various smaller generic drug producers globally.

The market participants are primarily focused on the cost-effective manufacturing and distribution of the active pharmaceutical ingredient (API) and finished dosage forms. Competition is driven by price and supply chain reliability.

What is the Global Market Size and Projected Growth Rate for Methanthelene Bromide?

The global market for methanthelene bromide is considered a niche segment within the broader gastrointestinal drug market. Precise, up-to-date market size figures are difficult to ascertain due to its generic status and the lack of dedicated market reports for such specific, older compounds. However, industry estimates suggest a market size in the low tens of millions of U.S. dollars annually.

Projected Growth Rate: The projected growth rate for methanthelene bromide is expected to be flat to slightly negative. Several factors contribute to this outlook:

Therapeutic Obsolescence: The advent of more effective and safer alternatives for its primary indications has significantly reduced its prescription volume.
Limited New Applications: A lack of substantial clinical research identifying new, high-demand therapeutic uses for methanthelene bromide.
Cost-Effectiveness of Alternatives: Newer drugs, while potentially more expensive per unit, offer better patient outcomes and reduced healthcare resource utilization, making them the preferred choice for payers and prescribers.

Comparative Market Dynamics:

Proton Pump Inhibitors (PPIs) Market: This segment is valued in the billions of U.S. dollars and continues to grow, driven by widespread use in acid-related disorders.
H2 Receptor Antagonists Market: Also a significant market, though facing some erosion from PPIs and newer drug classes.
Newer GI Therapies (e.g., biologics for IBD): These represent rapidly growing, high-value segments.

Methanthelene bromide's market share is minuscule in comparison to these broader categories.

What are the Key Revenue Drivers and Cost Structures?

The revenue drivers for methanthelene bromide are primarily linked to its sales volume as a generic medication.

Revenue Drivers:

Prescription Volume: The number of prescriptions written by healthcare professionals. This is the primary determinant of revenue.
Average Selling Price (ASP): As a generic, ASP is heavily influenced by competitive pricing among manufacturers.
Geographic Distribution: Sales are influenced by the prevalence of specific gastrointestinal conditions and prescribing patterns in different global regions.
Healthcare Reimbursement Policies: While less of a driver for older generics than for novel drugs, formulary placement and reimbursement levels can still influence prescribing.

Cost Structures for Manufacturers:

API Manufacturing Costs: The cost of synthesizing methanthelene bromide API. This is a significant component, influenced by raw material prices and production efficiency.
Formulation and Manufacturing of Finished Dosage Forms: Costs associated with tablet or capsule production, packaging, and quality control.
Regulatory Compliance: Costs associated with maintaining Good Manufacturing Practices (GMP) and meeting regulatory requirements in different markets.
Distribution and Supply Chain Management: Costs related to warehousing, logistics, and ensuring product availability.
Marketing and Sales (Limited for Generics): Generally, generic manufacturers have lower marketing expenses compared to originators. Efforts focus on B2B sales to wholesalers and pharmacies.
Research and Development (Minimal): R&D expenditure for methanthelene bromide is negligible, primarily focused on process optimization rather than new drug discovery or formulation development.

The profit margins for generic methanthelene bromide are typically thin due to intense price competition. Manufacturers rely on high-volume production and efficient operations to maintain profitability.

What are the Competitive Threats and Market Challenges?

The competitive landscape for methanthelene bromide is defined by generic competition and the ongoing evolution of gastrointestinal therapeutics.

Competitive Threats:

Intense Generic Competition: Numerous manufacturers produce methanthelene bromide, leading to downward price pressure and reduced profit margins for all players. Price wars are common in the generic API and finished product markets.
Superior Alternative Therapies: The primary competitive threat comes from newer, more efficacious, and safer drug classes for gastrointestinal disorders, including:
- Proton Pump Inhibitors (PPIs) for acid suppression.
- H2 Receptor Antagonists for acid suppression.
- Antispasmodics with different mechanisms of action.
- Therapies for specific conditions like Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS) that offer targeted relief.
Off-Label Use Limitations: While off-label use can sometimes extend the life of older drugs, the availability of highly effective alternatives limits significant off-label prescribing for methanthelene bromide.
Physician and Patient Preference: Healthcare providers and patients increasingly favor newer, evidence-based treatments with better safety profiles and more predictable outcomes.

Market Challenges:

Declining Prescription Volume: The fundamental challenge is the steady erosion of prescription volume as physicians switch to preferred therapies.
Lack of Differentiation: As a pure generic, methanthelene bromide offers no unique selling proposition beyond cost.
Regulatory Hurdles for New Indications: Pursuing new indications would require extensive and costly clinical trials, which is unlikely to be economically viable for a drug with its current market profile and patent status.
Supply Chain Vulnerabilities: While not unique to methanthelene bromide, any disruption in the API or finished product supply chain can lead to temporary shortages, potentially impacting an already diminished market share.
Limited R&D Investment: The lack of R&D focus means no pipeline for improvements or new applications, further marginalizing the drug.

What is the Financial Outlook for Methanthelene Bromide?

The financial outlook for methanthelene bromide is one of continued decline, albeit potentially slow due to its entrenched presence in certain cost-sensitive markets or for specific, limited therapeutic niches.

Revenue Decline: Expect a steady, low-single-digit percentage decline in global revenue annually. This is driven by the shrinking prescription base.
Profitability Pressures: Profitability for manufacturers will remain under pressure due to intense price competition and the need for high-volume production to achieve economies of scale. Margins will likely remain tight.
Market Stalemate: No significant market expansion is anticipated. The market will likely stabilize at a low level, serving only a residual demand.
Acquisition Potential (Limited): Manufacturers with existing portfolios of older generics might acquire methanthelene bromide production lines to leverage existing infrastructure, but this is unlikely to be a significant growth driver. The focus would be on maintaining existing, albeit small, revenue streams.
Strategic Value: The strategic value of methanthelene bromide is diminishing. It is unlikely to attract significant new investment or R&D interest. Its primary value lies in its low cost and availability for specific, limited patient populations.

Financial Trajectory Summary:

Metric	Current Status	Projected Trajectory (3-5 Years)	Notes
Global Market Size	Low tens of millions USD	Stable to slight decline	Niche market, highly competitive.
Revenue Growth	Flat to negative	Negative	Driven by therapeutic obsolescence and generic competition.
Profit Margins	Thin	Stable to declining	Pressure from price wars and low volume.
R&D Investment	Negligible	Negligible	No new applications or significant formulation development expected.
Competitive Intensity	High	High	Dominated by generic manufacturers.
Strategic Importance	Low	Decreasing	Primarily a cost-effective option for residual demand.

The financial future of methanthelene bromide is characterized by a mature, declining market with limited upside potential. Its continued existence will depend on its ability to remain a cost-effective option for a small, persistent segment of the market.

Key Takeaways

Methanthelene bromide is an older, generic anticholinergic primarily used for gastrointestinal motility and secretion issues.
Its patent protection has expired, leading to a fragmented generic market with intense price competition.
The global market size is small, estimated in the low tens of millions of U.S. dollars, with a projected flat to negative growth rate.
Key revenue drivers are prescription volume and competitive pricing, while cost structures are dominated by API manufacturing and generic production efficiencies.
Competitive threats include superior alternative therapies (PPIs, H2 blockers) and ongoing generic rivalry.
The financial outlook is characterized by declining revenue and persistent profit margin pressures, with limited prospects for significant market expansion or R&D investment.

FAQs

1. What are the most significant factors driving the decline in methanthelene bromide's market share?

The primary drivers of market share decline are the development and widespread adoption of more efficacious and safer alternative medications for gastrointestinal disorders, such as proton pump inhibitors (PPIs) and H2 receptor antagonists, which have largely replaced methanthelene bromide in its historical indications.

2. Are there any emerging therapeutic applications for methanthelene bromide that could revitalize its market?

There is no substantial evidence of emerging therapeutic applications for methanthelene bromide. Research and development efforts in gastrointestinal therapeutics have shifted towards novel drug classes with more targeted mechanisms of action and improved safety profiles, making significant investment in older compounds like methanthelene bromide unlikely.

3. How does the pricing of methanthelene bromide compare to newer gastrointestinal drugs?

As a generic medication, methanthelene bromide is priced significantly lower than newer, branded gastrointestinal drugs. Its pricing is determined by competitive generic market dynamics, aiming for cost-effectiveness in its limited applications. Newer drugs, particularly biologics or advanced chemical entities, command premium pricing based on innovation, efficacy, and patent protection.

4. What are the primary regulatory considerations for manufacturers of methanthelene bromide?

Manufacturers must adhere to Good Manufacturing Practices (GMP) to ensure product quality, safety, and efficacy. Regulatory considerations also include compliance with national drug regulatory agencies (e.g., FDA, EMA) for market authorization, labeling requirements, and pharmacovigilance. For generics, demonstrating bioequivalence to the reference listed drug is also critical.

5. What is the typical supply chain structure for methanthelene bromide?

The supply chain typically involves API manufacturers who synthesize the active ingredient. This API is then sold to finished dosage form manufacturers who produce the final product (e.g., tablets). These finished products are then distributed through wholesalers and pharmacy benefit managers to retail pharmacies and healthcare institutions for dispensing to patients.

Citations

[1] Data regarding historical patent expirations and generic availability of pharmaceutical compounds like methanthelene bromide are derived from general pharmaceutical industry knowledge and publicly accessible databases tracking drug lifecycles. Specific patent numbers and grant dates for older compounds are often difficult to retrieve or are less relevant than the fact of their expiration.

[2] Market size and growth rate projections are based on broad industry analyst reports concerning the global gastrointestinal drug market and an extrapolation for niche generic compounds, recognizing the lack of specific reports for methanthelene bromide itself. Estimates are derived from understanding the relative size of therapeutic classes and the impact of genericization.

[3] Information on manufacturers is based on general knowledge of the generic pharmaceutical industry and companies that historically or currently participate in the production of older generic medications. Specific active product portfolios can change frequently through mergers, acquisitions, and divestitures.

[4] Information on therapeutic uses and mechanisms of action is derived from pharmacological literature and standard drug compendia.

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	1
DailyMed Link:	methantheline bromide at DailyMed

Methantheline bromide - Generic Drug Details

What are the generic sources for methantheline bromide and what is the scope of patent protection?

Summary for methantheline bromide

Recent Clinical Trials for methantheline bromide

Anatomical Therapeutic Chemical (ATC) Classes for methantheline bromide

US Patents and Regulatory Information for methantheline bromide

METHANTHELINE BROMIDE: MARKET DYNAMICS AND FINANCIAL TRAJECTORY