Last Updated: September 28, 2026

hexafluorenium bromide - Profile


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What are the generic sources for hexafluorenium bromide and what is the scope of freedom to operate?

Hexafluorenium bromide is the generic ingredient in one branded drug marketed by Medpointe Pharm Hlc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for hexafluorenium bromide
US Patents:0
Tradenames:1
Applicants:1
NDAs:1

US Patents and Regulatory Information for hexafluorenium bromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medpointe Pharm Hlc MYLAXEN hexafluorenium bromide INJECTABLE;INJECTION 009789-003 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

Hexafluorenium Bromide Investment Scenario and Fundamentals Analysis

Last updated: February 28, 2026

What Is Hexafluorenium Bromide?

Hexafluorenium bromide is a quaternary ammonium compound used primarily as a neuromuscular blocking agent in anesthesia. Its chemical formula is C₂₄H₂₂BrN₂. It acts as a competitive antagonist at nicotinic acetylcholine receptors, facilitating muscle relaxation during surgical procedures. The drug's clinical use remains limited by the availability of newer agents with better safety profiles and pharmacokinetics.

Market Overview

The global neuromuscular blocking agents market was valued at approximately $3.8 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 4.5% through 2028, driven by increased surgical procedures and expanding anesthesia use in developing regions.

Hexafluorenium bromide's market share has declined due to:

  • Development of drugs with improved safety profiles, such as rocuronium and vecuronium.
  • Regulatory restrictions arising from safety concerns, including its potential for prolonged paralysis and cardiovascular effects.

Clinical and Regulatory Status

  • Approval Status: Withdrawn or limited approval in several markets due to safety concerns.
  • Pharmacological Profile: Rapid onset, intermediate duration, but associated with histamine release and cardiovascular side effects.
  • Regulatory Restrictions: In some regions, it is classified as a discontinued or off-label drug, reducing market potential.

Patent and Intellectual Property Landscape

  • Patent Status: Original patents expired decades ago, with no recent patents or exclusivity rights.
  • Implications: Limited protection against generics reduces pricing power and margins.

Competitive Landscape

Major competitors include:

  • Drugs like rocuronium, vecuronium, and atracurium dominate the market.
  • These agents have better safety profiles, longer duration control, and wider acceptance.

Hexafluorenium bromide does not directly compete in current mainstream markets.

R&D and Commercialization Barriers

  • Low clinical demand due to safety concerns.
  • High risk of regulatory rejection or restrictions.
  • No current patent protection allowing exclusivity.

Financial Considerations

  • Market Size: Marginal, given the drug's current limited use and competition.
  • Cost of Development: High, with uncertain regulatory approval.
  • Potential Revenue: Minimal unless repositioned for a niche or novel indication.

Investment Outlook Summary

Aspect Status Implication
Market demand Low Declining with existing alternatives
Competitive advantage None No patent, safety issues limit positioning
Regulatory risk High Potential restrictions or bans
R&D costs High Resource-intensive with low probability of success
Revenue potential Marginal Limited by current clinical and regulatory landscape

Key Risks

  • Safety concerns with side effects.
  • Regulatory rejection or restriction.
  • Market obsolescence due to newer agents.
  • Limited patent protection prevents exclusivity gains.

Opportunities

  • Repositioning for niche or experimental indications.
  • Chemical modifications to improve safety.
  • Companion diagnostics or combination therapies.

Conclusion

Hexafluorenium bromide presents minimal investment value as a mainstream pharmaceutical product due to safety issues, patent expiry, and fierce competition. Investment prospects are limited to niche research, reformulation, or drug repurposing projects with clear pathways and clinical validation.

Key Takeaways

  • Market presence has diminished; current use is marginal.
  • Safety profile concerns outweigh advantages compared to competitors.
  • Patent expiry and lack of exclusivity undermine profitability.
  • Regulatory hurdles pose significant risks for development.
  • Limited near-term revenue opportunities exist.

FAQs

  1. Is there ongoing research or interest in reformulating hexafluorenium bromide?
    No substantial research efforts are publicly reported due to its safety profile and market decline.

  2. Can hexafluorenium bromide be repositioned for other medical conditions?
    Theoretically, yes — but no current studies or data support alternative indications.

  3. What are the primary safety concerns with hexafluorenium bromide?
    It can cause cardiovascular effects, including tachycardia, hypotension, and histamine release.

  4. Are there regulatory pathways to reintroduce or modify this drug?
    Regulatory agencies generally favor safer, more effective alternatives; reintroduction would require significant safety data.

  5. What is the outlook for similar neuromuscular blocking agents?
    They continue to evolve with better safety profiles, diminishing the relevance of older agents like hexafluorenium bromide.


References

  1. MarketWatch. (2022). Global neuromuscular blocking agents market report.
  2. FDA. (2020). Summary basis for regulatory action on neuromuscular blocking agents.
  3. PatentScope. (2023). Patent status for hexafluorenium and derivatives.
  4. Grand View Research. (2021). Anesthesia drugs market analysis.
  5. World Health Organization. (2018). Safety profiles of neuromuscular blocking drugs.

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