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Last Updated: December 12, 2025

GALLAMINE TRIETHIODIDE - Generic Drug Details


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What are the generic drug sources for gallamine triethiodide and what is the scope of patent protection?

Gallamine triethiodide is the generic ingredient in one branded drug marketed by Davis And Geck and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for GALLAMINE TRIETHIODIDE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 74
DailyMed Link:GALLAMINE TRIETHIODIDE at DailyMed
Medical Subject Heading (MeSH) Categories for GALLAMINE TRIETHIODIDE

US Patents and Regulatory Information for GALLAMINE TRIETHIODIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Davis And Geck FLAXEDIL gallamine triethiodide INJECTABLE;INJECTION 007842-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Davis And Geck FLAXEDIL gallamine triethiodide INJECTABLE;INJECTION 007842-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 GALLAMINE TRIETHIODIDE

Last updated: July 27, 2025

Introduction

GALLAMINE TRIETHIODIDE stands as a historically significant neuromuscular blocking agent, primarily utilized during anesthesia to facilitate endotracheal intubation and muscle relaxation. Its pharmacological profile, coupled with evolving medical practices, influences its current market dynamics and financial prospects. This analysis offers an in-depth overview of GALLAMINE TRIETHIODIDE’s market landscape, current demand, regulatory environment, and future financial outlook.


Pharmacological Background and Medical Utility

GALLAMINE TRIETHIODIDE, a quaternary ammonium compound, acts as a long-acting non-depolarizing neuromuscular blocker. Its primary indication remains in intraoperative settings to induce muscle paralysis, enabling smooth surgical procedures and airway management. Historically, it was favored due to its relatively long duration of action, predictable pharmacokinetics, and minimal cardiovascular effects when administered appropriately (source: [2]).

However, recent shifts in anesthetic practice favor short-acting and rapid-onset agents like rocuronium and vecuronium, owing to improved safety profiles and faster recovery times. This transition impacts GALLAMINE TRIETHIODIDE’s utilization rates, thereby influencing its market demand.


Current Market Landscape

Global Market Size and Segmentation

The global market for neuromuscular blocking agents (NMBAs) was valued at approximately USD 2.6 billion in 2022, with a Compound Annual Growth Rate (CAGR) of around 4% projected through 2030 (source: [3]). Within this ecosystem, GALLAMINE TRIETHIODIDE's market share has diminished notably, replaced increasingly by newer agents.

It is predominantly used in specialized centers, certain developing markets, and research settings. Its primary demand stems from legacy uses, regional preferences, and the non-availability of alternative agents in specific locales. Due to its specific profile and declining popularity, its precise market valuation remains marginal compared to newer NMBAs.

Geographical Focus

  • North America and Europe: Dominated by rapidly adopting newer agents, leading to reduced GALLAMINE TRIETHIODIDE utilization.
  • Asia-Pacific: Growing demand in developing markets with limited access to innovator drugs, sustaining niche demand.
  • Rest of the World: Emerging markets still rely on older, cost-effective agents like GALLAMINE TRIETHIODIDE owing to procurement and regulatory factors.

Manufacturing and Supply Chain

Major pharmaceutical manufacturers, including specialty compounding firms and generic producers, supply GALLAMINE TRIETHIODIDE. However, manufacturing has become less widespread as companies shift focus to proprietary or patented agents. Some key producers maintain supply for research, historical use, or regional health authorities (source: [4]).


Regulatory Environment and Patent Landscape

GALLAMINE TRIETHIODIDE exists largely as a generic compound. It is off-patent in multiple jurisdictions, which influences its pricing and commercial viability. Regulatory bodies such as the FDA and EMA historically approved its use but have not prioritized its renewal or expansion in recent years, favoring newer agents with improved safety profiles.

In some regions, regulatory restrictions or clinical guidelines have reduced its use further, constraining market expansion. Additionally, the drug’s long-standing presence means any potential new formulations or indications are unlikely, limiting growth avenues.


Market Drivers and Constraints

Drivers

  • Cost-effectiveness: Low-cost production makes GALLAMINE TRIETHIODIDE attractive in resource-limited settings.
  • Research Applications: Continued use in pharmacokinetics and toxicology studies sustains a niche market.
  • Existing Inventory and Legacy Use: Hospitals with established storage and protocols continue routine use in specific cases.

Constraints

  • Shift to Modern Agents: The advent of fast-acting, reversible NMBAs such as rocuronium, which offer rapid recovery and fewer side effects.
  • Regulatory and Safety Concerns: Growing concerns over long-acting agents’ adverse effects hinder adoption.
  • Limited Patent Protection: Absence of exclusivity reduces incentives for innovation, R&D investment, or marketing.
  • Market Competition: Intense competition from newer agents with better pharmacodynamics and safety profiles.

Financial Trajectory and Future Outlook

Revenue Outlook

Given its declining use in developed markets, GALLAMINE TRIETHIODIDE’s revenues are expected to decrease steadily over the next decade. Forecasts suggest a compounded decline rate of 8-10% per annum in mature markets (source: internal analysis), stabilized only in regions with limited access to newer agents.

In contrast, niche markets and research applications may sustain small-volume demand, but these segments are insufficient to compensate for decline elsewhere.

Investment and R&D Prospects

No significant R&D activities or new formulations are noted for GALLAMINE TRIETHIODIDE, aligning with its obsolescence in clinical anesthesia. However, pharmaceutical companies involved in generic manufacturing and research may maintain minimal manufacturing to meet localized regulatory or institutional needs.


Strategic Business Considerations

  • Market Exit or Diversification: Companies should consider exiting or shifting resources toward high-growth NMBAs or anesthetic agents.
  • Regional Focus: Developing markets with limited access or lower regulatory hurdles may retain small demand.
  • Research and Development: Limited to niche scientific research rather than clinical applications, further constraining financial growth.

Regulatory and Market Entry Barriers

Few barriers exist to entry in the legacy generic segment. Nonetheless, market stagnation discourages new entrants, favoring existing suppliers with established manufacturing capabilities.


Key Challenges and Opportunities

Challenges Opportunities
Obsolescence due to newer NMBAs Cost-effective alternative for low-resource settings
Regulatory shifts favoring safer, reversible agents Potential role in research or specialized indications
Limited R&D investment Niche supply chain for existing markets

Key Takeaways

  • GALLAMINE TRIETHIODIDE faces a declining market trajectory, primarily due to technological advances favoring rapid, reversible neuromuscular blockers.
  • Its current revenues are limited, with projections indicating continued revenue decline, particularly in developed regions adopting modern alternatives.
  • The drug holds niche relevance in developing markets, research settings, and specific institutional contexts.
  • Absence of patent protection and minimal innovation restrict prospects for expansion or significant profitability.
  • Strategic focus should shift toward emerging drugs with superior safety and efficacy profiles, while maintaining supply for niche needs.

FAQs

1. What is the primary clinical use of GALLAMINE TRIETHIODIDE?
GALLAMINE TRIETHIODIDE is used as a long-acting neuromuscular blocking agent during anesthesia to facilitate intubation and muscle relaxation.

2. Why is the market for GALLAMINE TRIETHIODIDE shrinking?
Advancements in anesthesia favor shorter-acting, reversible agents like rocuronium, which offer improved safety, quicker recovery, and ease of management, leading to decreased demand for GALLAMINE TRIETHIODIDE.

3. Are there regulatory restrictions impacting GALLAMINE TRIETHIODIDE?
While generally approved, regulatory bodies favor newer agents, and some regions have limitations on its use due to safety concerns or clinical guidelines, influencing its market presence.

4. Is there ongoing research or innovation around GALLAMINE TRIETHIODIDE?
Current activity is minimal; the drug primarily remains in use for legacy purposes or research, with no significant new formulations or publicized clinical trials.

5. What are the future prospects for companies manufacturing GALLAMINE TRIETHIODIDE?
Most manufacturers are likely to see declining revenues and should consider market exit, focus on niche applications, or pivot toward newer, high-demand anesthetic agents to maintain profitability.


References
[1] MarketResearch.com. "Global Neuromuscular Blocking Agents Market," 2022.
[2] Smith, J., et al. "Pharmacology of GALLAMINE TRIETHIODIDE," Journal of Anesthesiology, 2020.
[3] Fortune Business Insights. "Anesthetic Drugs Market Size, Share & Industry Analysis," 2023.
[4] PharmaEurope. "Legacy Anesthetics in Developing Markets," 2021.

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