demecarium bromide - Profile

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

Demecarium bromide is the generic ingredient in one branded drug marketed by Merck and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for demecarium bromide

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for demecarium bromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck	HUMORSOL	demecarium bromide	SOLUTION/DROPS;OPHTHALMIC	011860-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Merck	HUMORSOL	demecarium bromide	SOLUTION/DROPS;OPHTHALMIC	011860-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Investment Scenario and Fundamentals Analysis for Demecarium Bromide

Last updated: April 1, 2026

Demecarium bromide is a cholinesterase inhibitor historically used for glaucoma treatment. Its current market presence is limited, with no major recent approval activity or significant pipeline developments. Analyzing potential investment in this compound involves assessing market dynamics, regulatory landscape, patent status, and scientific relevance.

Market Overview

Demecarium bromide (brand name: Humorsol) was once prescribed for ocular glaucoma but is now largely phased out due to newer medications with better efficacy and safety profiles. Its primary use was for intraocular pressure reduction.

Market Size and Demand

• Estimated global glaucoma treatment market: $6 billion in 2022, with single-digit growth rates.
• Demecarium bromide's market share: negligible; replaced by prostaglandin analogs, beta-blockers, and α-agonists.
• Current demand: minimal; no recent sales reports or commercial pipelines.

Competitive Landscape

• Competing drugs: Latanoprost, Bimatoprost, Tafluprost, which dominate due to efficacy and safety.
• Market entry barriers for old drugs: patent expiration, manufacturing costs, and limited clinical utility.

Regulatory and Patent Environment

Regulatory Status

• Approved in the mid-20th century; withdrawn or discontinued in many markets due to safety concerns.
• FDA and EMA approvals: expired or revoked for most indications.
• Recent regulatory activity: none for new indications or formulations.

Patent Status

• Original patents expired decades ago.
• No recent patents or exclusivities.
• No active patent applications or orphan drug designations.

Scientific and R&D Considerations

• Pharmacodynamics: inhibits cholinesterase to decrease intraocular pressure.
• Safety profile: side effects include miosis, ocular inflammation, and systemic cholinergic symptoms.
• Clinical utility: limited to refractory cases, but replaced by safer, more effective options.
• Potential for repositioning: theoretical; no current scientific interest or ongoing research.

Investment Fundamentals

Criterion	Assessment
Market Demand	Very low; largely obsolete
Competitive Advantage	None; replaced by better drugs
Regulatory Barriers	Significant; no recent approvals
Patent Protection	Expired; no new rights granted
R&D Viability	Low; limited clinical relevance
Revenue Potential	Negligible
Strategic Positioning	Not aligned with current market trends

Strategic Insights

• Low commercial viability due to obsolescence and market competition.
• Limited scientific innovation; no active development or repositioning efforts.
• Asset value primarily as a historical compound, not an R&D candidate.

Key Takeaways

• Demecarium bromide no longer holds a significant market position.
• Patent expiration and regulatory withdrawal diminish investment appeal.
• Competitive landscape favors newer therapeutic agents.
• Scientific interest in repurposing is minimal; no ongoing development projects.
• Investment risk remains high with negligible upside potential.

FAQs

1. Is demecarium bromide still approved for any indications globally?
   No. Its approval was withdrawn or expired in major markets; no current approvals.

2. Can demecarium bromide be repositioned for new therapeutic uses?
   Limited scientific basis due to safety concerns and available better options.

3. Are there patent protections that could support R&D investment?
   No. Patent rights expired decades ago, providing no exclusivity.

4. What are the main competitors replacing demecarium bromide?
   Prostaglandin analogs (e.g., latanoprost), beta-blockers (e.g., timolol).

5. Is there any market niche where demecarium bromide could be relevant today?
   Minimal; primarily historical interest with no current clinical or commercial relevance.

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References

[1] Grand View Research. (2022). Glaucoma Drugs Market Size, Share & Trends Analysis.
[2] U.S. FDA Drug Approvals Database. (2023). Demecarium Bromide Summary.
[3] European Medicines Agency. (2022). List of Withdrawn Products.