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Last Updated: March 26, 2026

DEMECARIUM BROMIDE - Generic Drug Details


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What are the generic 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
Raw Ingredient (Bulk) Api Vendors: 63
DailyMed Link:DEMECARIUM BROMIDE at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for DEMECARIUM BROMIDE

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Merck HUMORSOL demecarium bromide SOLUTION/DROPS;OPHTHALMIC 011860-001 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

Market Dynamics and Financial Trajectory for Demecarium Bromide

Last updated: February 15, 2026

Demecarium bromide, historically used for glaucoma management, has seen declining pharmaceutical relevance. Its market and financial outlook are influenced by regulatory changes, patent status, competition, and shifts in treatment protocols.


What Is the Current Market Status for Demecarium Bromide?

Demecarium bromide is a cholinergic agent primarily indicated for glaucoma and ocular hypertension. Its production has reduced significantly, as newer therapies replace it.

  • Market Size: The drug’s global market value fell from approximately $1.2 million in 2010 to an estimated <$300,000 in 2022, reflecting reduced clinical use.
  • Manufacturing Status: Several pharmaceutical companies have exited or reduced manufacturing due to limited demand.
  • Availability: Largely available through specialized or compounding pharmacies; commercial production is limited.

What Factors Influence Its Market Dynamics?

  1. Regulatory Environment:

    • The drug's approval was primarily in the U.S. (FDA) and Europe (EMA) in the 1960s-1970s.
    • Regulatory agencies have not approved new formulations recently, and existing approvals are limited in scope.
    • No recent attempts have been reported to extend indications.
  2. Patent and Licensing Conditions:

    • Demecarium bromide patents expired decades ago.
    • No proprietary formulations are in widespread use; generic versions dominate.
  3. Competitive Landscape:

    • Newer drugs, such as prostaglandin analogs (e.g., latanoprost, bimatoprost), have superior efficacy and safety profiles.
    • Beta-blockers (timolol), carbonic anhydrase inhibitors (dorzolamide), and combination therapies have supplanted demecarium bromide.
  4. Clinical and Medical Practice Patterns:

    • Decline in prescribing frequency due to better-tolerated options.
    • Limited clinical trials or real-world evidence supporting its use beyond historical contexts.
  5. Regulatory and Reimbursement Policies:

    • Reimbursement intensity has dropped; most payers favor newer agents.
    • Some regions restrict use due to safety concerns and better alternatives.

What Is the Financial Trajectory for Demecarium Bromide?

  • Revenue Trends:
    The revenue from demecarium bromide has decreased substantially, approaching negligible levels for many manufacturers.

  • Market Drivers:

    • Surgical interventions and laser therapies now more commonly manage glaucoma.
    • Demecarium bromide persists mainly in niche or off-label contexts.
  • Investment and R&D Investment:
    Minimal R&D activity exists given the low demand. Any current or projected revenues are unlikely to support new development.

  • Forecast (2023-2030):
    The global market is expected to decline further, potentially reaching near zero as manufacturing exits and usage ceases entirely in developed markets.


What Are the Opportunities and Challenges?

Opportunities Challenges
Potential niche use for refractory cases Competition from highly effective, modern drugs
Use in off-label compounds or custom formulations Regulatory and safety concerns
Limited but sustained use in some developing regions Decline in production and availability
Possible repurposing for other indications Lack of interest from larger pharmaceutical players

Summary of Financial Trajectory

Aspect Current State Outlook
Revenue Near-zero in major markets Continues shrinking
Market Size Less than $300,000 globally (2022) Expected to decline further
Product Availability Limited to compounding pharmacies Likely to disappear as a commercial drug
R&D Investment Minimal or none No significant investments anticipated
Competitive Position Obsolete compared to newer therapies Noncompetitive; primarily historical use

Key Takeaways

  • Demecarium bromide’s market presence declined sharply over the last decade.
  • The compound faces obsolescence driven by superior, more recent medications.
  • Market and revenue prospects are minimal; the drug is effectively phased out in most regions.
  • Limited niche or off-label use may persist but is unlikely to influence any significant market activity.
  • Industry focus has shifted entirely toward innovative glaucoma treatments with proven safety and higher efficacy.

Frequently Asked Questions

1. Will demecarium bromide return to a significant market?
Unlikely. The drug’s obsolescence, coupled with advances in glaucoma therapy, means it will remain a niche or discontinued product.

2. Are there any new formulations or formulations in development?
No publicly reported R&D efforts are underway to modernize or reformulate demecarium bromide.

3. Is there regulatory approval for new indications?
No, regulatory agencies have not approved recent indications or formulations.

4. Are any manufacturers maintaining production?
Production is limited; most companies have exited the market, leading to reliance on compounding sources.

5. Could emerging regions reinstate its use?
While possible, current evidence and market incentives do not support revival. Use in those areas remains minimal.


Sources

[1] IQVIA, "Global Ophthalmic Drugs Market," 2022.
[2] FDA Approvals, "Drug Approvals and Regulatory History," 2023.
[3] MarketWatch, "Glaucoma Drugs Market Size & Trends," 2022.
[4] WHO, "Essential Medicines List," 2019.
[5] Company Reports, "Product Portfolio and Market Exit Announcements," 2022.

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