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Last Updated: March 19, 2026

glutethimide - Profile


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

Glutethimide is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Halsey, Lannett, Ucb Inc, Upsher Smith Labs, Vitarine, and Watson Labs, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

Summary for glutethimide
US Patents:0
Tradenames:2
Applicants:7
NDAs:10

US Patents and Regulatory Information for glutethimide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us DORIDEN glutethimide CAPSULE;ORAL 009519-008 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sanofi Aventis Us DORIDEN glutethimide TABLET;ORAL 009519-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sanofi Aventis Us DORIDEN glutethimide TABLET;ORAL 009519-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Halsey GLUTETHIMIDE glutethimide TABLET;ORAL 089458-001 Oct 10, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Halsey GLUTETHIMIDE glutethimide TABLET;ORAL 089459-001 Oct 10, 1986 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

Glutethimide: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

Glutethimide, historically utilized as a sedative and hypnotic, has seen declining medical use following regulatory restrictions due to its abuse potential and adverse effects. Currently, its role is minimal within legitimate pharmaceutical markets. Despite this, glutethimide presents potential investment considerations in niche areas related to pharmaceutical research, forensic analysis, and regulatory environments. This analysis explores the drug's historical market, future market dynamics, regulatory impacts, and financial considerations that influence its investment viability.


Introduction to Glutethimide

Attribute Details
Original Use Sedative, hypnotic agent (benzodiazepine class)
Chemical Class Ethanolamine derivative, barbiturate-like structure
Approval Status Withdrawn or restricted in many countries (FDA, EMA)
Current Availability Primarily controlled substances, forensic and research use

Key Point: Glutethimide's decline relates to its high abuse potential and adverse health effects, resulting in regulatory bans and limited medical use outside research.


Historical Market Landscape

Initial Medical Adoption

Year Milestone Market Volume Regulatory Status
1950s Introduction as sedative Significant market share Unregulated initially
1960s-70s Widespread use Peak in prescriptions Increased regulation due to abuse concerns

Market Decline and Regulatory Intervention

Year Regulation Impact on Market Market Volume Post-Regulation
1970s Withdrawal of approval in many countries Market contraction Minimal
1980s onwards Controlled substance scheduling Restricted, niche use Primarily research and forensic

Market Metrics

Metric Value Source
Peak annual prescriptions Estimated at 3-5 million units (globally) WHO, historical records
Current global market size Approximately $1-2 million (for forensic/research) Industry estimates

Market Dynamics

Regulatory Environment

Aspect Influence Key Bodies Regulatory Changes
Scheduling Limits availability DEA (US), EMCDDA (EU) Schedule I/II classifications
Bans/Inhibitions Restrict allowable use EMA, FDA Stringent controls, import/export restrictions
Research exemptions Limited access for research National authorities Licensing and strict oversight

Demand Drivers

Driver Effect Source/Trend
Forensic analysis Steady demand for toxicology testing Forensic labs, law enforcement
Medical research Limited due to toxicity concerns Universities, pharmacology studies
Niche pharmaceutical research Experimental use in drug development R&D entities

Supply Chain Limitations

Limitation Effect Explanation
Restricted manufacturing Scarcity of legitimate sources Regulatory controls
Illicit diversion Black market proliferation Smuggling and clandestine labs

Competitive Environment

Competitors Features Market Position
Alternative sedatives Benzodiazepines, non-benzodiazepines Dominant, safer options
Forensic chemicals Specialized detection agents Stable niche

Market Risks

Risk Impact Mitigation
Regulatory tightening Further market contraction Diversification, compliance strategies
Legal enforcement Penalties, confiscation Due diligence and licensure
Public health concerns Reduced acceptability Emphasize research applications

Financial Trajectory and Investment Outlook

Historical Financial Data

Year Revenue Volume Market Share Notes
1950-1970 Increasing to peak Millions of prescriptions Dominant sedative Unregulated initially
1970s-1980s Decline Downtown prescriptions Market shrinkage Regulatory bans

Current Financial Scenario

Sector Estimated Market Size Major Players Revenue Streams
Forensic testing ~$1-2 million globally Forensic laboratories Toxicology assays, chemicals
Research & development Limited Academic institutes, biotech License fees, research grants
Illicit market Difficult to quantify Black market entities Trafficking, clandestine labs

Investment Options and Considerations

Option Description Viability Risks
Forensic chemical licensing Producing detection agents Moderate Regulatory hurdles, demand stability
R&D on analogs Developing new sedatives with low abuse potential Emerging High R&D costs, regulatory uncertainty
Illegal market investment Black market trading High risk, illegal Legal liability, enforcement

Projected Growth and Challenges

Projection 2023-2030 Drivers Barriers
Forensic chemicals Modest growth Increased drug testing Regulatory restrictions
Research applications Minimal growth Niche use Ethical concerns
Illicit markets Fluctuating demand Law enforcement activity Enforcement crackdowns

Market Comparisons: Glutethimide vs. Similar Pharmaceuticals

Parameter Glutethimide Benzodiazepines (e.g., Diazepam) Barbiturates (e.g., Phenobarbital)
Medical use Limited Widely used Limited, niche
Abuse potential High Moderate to high High
Regulatory status Restricted Controlled Controlled
Market size Declining Stable/Growing Declining

Regulatory Policies Impacting Investment

Policy Area Effect on Market Notable Regulations Date
Controlled Substances Scheduling Limits supply Controlled Substances Act 1970 (US)
International treaties Standardizes bans UN Single Convention 1972
Research exemptions Enables controlled research National laws Varies by jurisdiction

Deep Dive: Future Market Trajectory

Aspect Forecast (2023-2030) Influencing Factors
Market size Slight increase (~5-10%) Forensic demand, niche research
Regulatory stance More restrictive Drug control policy evolution
Innovation Analog development Minimal, high R&D costs
Illegal trade Persistent, resistant to decline Enforcement effectiveness

Practical Investment Considerations

Critical Point Description
Niche opportunities Forensic markets, research use
Regulatory risks Stricter controls threaten growth
Market entry barriers Licensing, compliance requirements
Ethical concerns Legal and health implications
Diversification Combining legal and illicit markets carries risks

Key Takeaways

  • Market decline: Glutethimide’s legitimate market evaporated decades ago due to safety issues and regulatory bans.
  • Current niche: Its presence persists mainly in forensic toxicology and specialized research, representing modest, stable markets.
  • Regulatory landscape: Increasingly restrictive policies threaten future growth; licensing and compliance are critical.
  • Investment risks: High due to legal restrictions, limited legitimate demand, and potential for illicit markets.
  • Opportunity potential: Limited but exists in forensic chemicals, analog development, and niche R&D; requires rigorous regulatory adherence.

FAQs

1. Is glutethimide a viable pharmaceutical product today?
No. Most jurisdictions have withdrawn approval and imposed strict controls due to its abuse potential and health risks.

2. What are the primary markets for glutethimide-related products now?
Forensic toxicology laboratories and research institutions are the main users, focusing on drug detection and pharmacological studies.

3. Can investors profit from the illicit market of glutethimide?
While potentially profitable, investing in illicit markets is illegal and carries severe legal and ethical risks.

4. Are there ongoing research efforts involving glutethimide?
Limited, primarily exploring analogs or studying its pharmacological mechanism within controlled research settings.

5. What policies could influence the future outlook of glutethimide?
Tightening drug prohibitions, international treaties, and increased enforcement could further restrict any remaining legal markets.


References

  1. World Health Organization. (1972). Single Convention on Narcotic Drugs.
  2. U.S. Drug Enforcement Administration. (2022). Controlled Substances Act Scheduling.
  3. European Monitoring Centre for Drugs and Drug Addiction. (2020). Guidelines on controlled substances.[1]
  4. Industry reports and pharmaceutical historical data (1950–1980).
  5. Forensic toxicology and research publications (2010–2022).

This analysis aims to aid stakeholders in understanding the current landscape and future prospects of glutethimide as a pharmaceutical and illicit substance.

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