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Last Updated: March 26, 2026

BROMANYL Drug Patent Profile


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Summary for BROMANYL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 63
Patent Applications: 806
DailyMed Link:BROMANYL at DailyMed
Drug patent expirations by year for BROMANYL

US Patents and Regulatory Information for BROMANYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alpharma Us Pharms BROMANYL bromodiphenhydramine hydrochloride; codeine phosphate SYRUP;ORAL 088343-001 Aug 15, 1984 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 Bromanyl (Bromofentanyl)

Last updated: February 20, 2026

What Is Bromanyl (Bromofentanyl)?

Bromanyl, chemically known as bromofentanyl, is a synthetic opioid that shares structural similarities with fentanyl. It is classified as a potent Schedule I substance in the US and has been identified as a psychoactive substance with abuse potential. Its chemical formula is C_22H_26BrN_2O, with a molecular weight of approximately 412.36 g/mol.

Market Landscape and Regulatory Environment

Current Legal Status

  • United States: Classified as a Schedule I controlled substance under the Controlled Substances Act as of 2018. This status bans production, distribution, and possession without DEA authorization.
  • European Union: Controlled under the Psychoactive Substances Act, with specific references to fentanyl analogs.
  • Asia: Regulations vary; some countries have scheduled similar analogs under strict drug laws.

Supply Chain and Manufacturing

Limited manufacturing exists due to regulatory restrictions and its classification as a controlled substance. Illicit production occurs in clandestine labs, primarily for illicit markets.

Scientific and Medical Research

Preclinical research investigates bromanyl's receptor binding affinity, toxicity, and potential for medical applications, but no approved medical use exists currently.

Market Demand Drivers

Illicit Market

Bromanyl is part of the broader fentanyl analogs subclass, which accounts for a significant share of synthetic opioid-related overdoses.

  • Demand Factors:
    • Replacement for other fentanyl variants.
    • Use in adulterated illicit drugs to increase potency.
    • High profitability due to small volume requirements, given potency.

Legal and Medical Use

  • No approved therapeutic application.
  • Research into analgesic properties remains experimental and lacks commercial development.

External Factors

  • Law enforcement crackdowns limit clandestine manufacturing.
  • Rising global opioid overdose crisis prompts regulatory tightening.
  • Synthetic opioid market growth linked to increased demand for potent painkillers.

Financial Trajectory and Investment Considerations

Investment in Development and Detection Technologies

  • Companies involved in drug testing and forensic analysis develop detection kits for emerging fentanyl analogs, including bromanyl.
  • Market estimates for fentanyl analog detection technologies projected to grow at a compound annual growth rate (CAGR) of 8% over 2023-2028 [1].

Pharmaceutical Development Prospects

  • No current pharmaceutical development pipeline for bromanyl.
  • Research on analogs with medicinal potential remains restricted by legal controls.

Market Risks and Barriers

  • Legal risks: Rapid scheduling increases compliance costs and limits commercial opportunities.
  • Market-wide restrictions hinder production, distribution, and sales.
  • Reputational risks for entities involved in illicit activities or unregulated research.

Market Size Estimation

The global illicit synthetic opioid market, driven by fentanyl analogs, was valued at approximately USD 4.5 billion in 2022 and is expected to grow at a CAGR of 4.3% until 2030 [2]. However, bromanyl-specific sales remain undocumented due to clandestine production.

Comparative Analysis with Fentanyl

Parameter Fentanyl Bromanyl (Bromofentanyl)
Legal Status Schedule II (medical use) Schedule I (illegal)
Potency 80–100 times morphine Estimated comparable or higher
Medical Use Anesthesia, severe pain No approved use
Market Size Multi-billion dollar Unknown, illicit market only

Market Outlook

  • Short-term: Regulatory environment will suppress legitimate markets for bromanyl; clandestine activities may expand until law enforcement vectors adapt.
  • Long-term: No foreseeable legal market expansion; detection technology markets for forensic analysis will continue to grow.

Key Takeaways

  • Bromanyl exists solely in illicit markets and research contexts; no approved medical applications exist.
  • Its classification as a Schedule I substance limits production, distribution, and commercial investment.
  • Global synthetic opioid market growth and detection technology necessities drive indirect financial activity.
  • Rising overdoses strengthen regulatory controls, further constraining market prospects.
  • The illicit size of bromanyl remains unquantified but is part of the broader fentanyl analog market, valued at USD 4.5 billion in 2022.

Frequently Asked Questions

1. Can bromanyl be synthesized legally?
No. As a Schedule I controlled substance in the US and similarly regulated elsewhere, synthesis without explicit authorization is illegal.

2. Are there medical benefits associated with bromanyl?
No approved medical benefits are currently recognized; research is limited to preclinical studies.

3. How does the law enforcement impact bromanyl's market?
Enhanced enforcement reduces clandestine production and distribution, limiting supply and increasing risks for illicit actors.

4. What is the role of detection technologies in the bromanyl market?
Detection kits assist law enforcement and forensic laboratories in identifying and quantifying fentanyl analogs, including bromanyl, supporting their market growth.

5. Is there potential for pharmaceutical development of bromanyl?
Legal restrictions make development unlikely; focus remains on detection and forensic analysis.

References

[1] MarketsandMarkets. (2023). Fentanyl analog detection market forecast.

[2] United Nations Office on Drugs and Crime (UNODC). (2022). Global synthetic opioid market analysis.

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