You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 27, 2026

NEMBUTAL Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


DrugPatentWatch® Litigation and Generic Entry Outlook for Nembutal

A generic version of NEMBUTAL was approved as pentobarbital sodium by SAGENT PHARMS INC on May 23rd, 2016.

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for NEMBUTAL?
  • What are the global sales for NEMBUTAL?
  • What is Average Wholesale Price for NEMBUTAL?
Summary for NEMBUTAL
US Patents:0
Applicants:3
NDAs:6
Raw Ingredient (Bulk) Api Vendors: 37
Clinical Trials: 1
DailyMed Link:NEMBUTAL at DailyMed
Drug patent expirations by year for NEMBUTAL
Recent Clinical Trials for NEMBUTAL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Washington University School of MedicineN/A

See all NEMBUTAL clinical trials

US Patents and Regulatory Information for NEMBUTAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sciegen Pharms NEMBUTAL pentobarbital ELIXIR;ORAL 083244-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Epic Pharma Llc NEMBUTAL SODIUM pentobarbital sodium CAPSULE;ORAL 084093-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sciegen Pharms NEMBUTAL pentobarbital sodium SUPPOSITORY;RECTAL 083247-003 Jan 25, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Epic Pharma Llc NEMBUTAL SODIUM pentobarbital sodium CAPSULE;ORAL 083245-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sciegen Pharms NEMBUTAL pentobarbital sodium SUPPOSITORY;RECTAL 083247-001 Jan 25, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sciegen Pharms NEMBUTAL pentobarbital sodium SUPPOSITORY;RECTAL 083247-002 Jan 25, 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 Nembutal (Pentobarbital)

Last updated: January 31, 2026

Summary

Nembutal (pentobarbital) is a barbiturate historically used as an anticonvulsant and sedative. Due to its high potential for misuse and addiction, regulatory controls have significantly curtailed its legal production and availability. This article provides a comprehensive analysis of the current market landscape, regulatory environment, and financial outlook for Nembutal, emphasizing the transition from widespread clinical use to restricted distribution and emerging black-market concerns. It aims to inform pharmaceutical stakeholders, investors, and policymakers about the evolving dynamics and future trends.


1. What is Nembutal (Pentobarbital), and what are its medical uses?

Aspect Details
Chemical Name Pentobarbital sodium
Therapeutic Class Barbiturate sedative-hypnotic
Common Medical Uses Seizure management, anesthesia for minor procedures, euthanasia (in some jurisdictions)
Historical Significance Once widely used for insomnia and seizures before being replaced by safer alternatives

Note: The primary clinical use of pentobarbital has diminished significantly due to safety concerns and the development of newer pharmaceuticals like benzodiazepines and non-barbiturate sedatives.


2. Regulatory landscape and legal restrictions

Region Regulations Current Status
United States Controlled Substance Act (Schedule II) Strictly regulated; limited medical use, primarily for euthanasia and animal sedation
European Union Controlled under necessitating prescription Restricted, banned for human use in many countries
Asia & Latin America Varies by country Generally tighter controls, though misuse persists in some regions

Key Regulatory Trends:

  • Global Classifications: Nembutal classified as a Schedule II or equivalent, reflecting high addiction potential.
  • Usage Restrictions: Many jurisdictions have banned medical use entirely, while some retain limited, narrowly defined applications.
  • Supply Chain Controls: Stringent import/export controls aimed at preventing diversion for illicit purposes.

Regulatory Impact:

  • Market Contraction: Many pharmaceutical companies have ceased production due to regulatory risks and liability.
  • Black Market Proliferation: Illegal trafficking routes have emerged, complicating enforcement and health policies.

3. Market size and current demand

Aspect Data & Trends
Pre-2010 Market Global demand estimated at several hundred metric tons annually, largely for medical and institutional use.
Post-2010 Decline Usage sharply decreased by >80% due to regulatory tightening and safety concerns.
Current Demand Primarily for veterinary euthanasia, clandestine use, and limited medical applications in certain jurisdictions.
Black Market Significant underground trade, with estimates of illicit consumption comparable to or exceeding official legal markets in certain regions.

Market Drivers:

  • Legal Sector: Declining due to strict regulations, with limited legal procurement channels.
  • Veterinary Market: Still active in some countries for euthanasia; however, alternatives are increasingly favored.
  • Illicit Market: Growing concern for misuse in suicides, overdose, and clandestine rites.

4. Market players, suppliers, and distribution channels

Stakeholder Role Notes
Pharmaceutical Manufacturers Producing for medical and veterinary markets Reduced to a handful due to regulatory risks
Regulatory Agencies Enforce controls DEA (US), EMA (EU), local authorities
Illegal Suppliers Distribute via black markets Ongoing supply chain disruptions and enforcement efforts
End-Users Hospitals, veterinarians, illicit consumers Decreasing legal medical use; illicit consumption rising

Major Pharmaceutical Manufacturers:

  • Historic Producers: Eli Lilly, Parke-Davis, and others historically manufactured Nembutal.
  • Current Production: Limited, often restricted to veterinary products or special exemptions.

5. Financial outlook and future projections

Period Key Trends Implications
Short-Term (1-3 years) Continued decline; possible resurgence of illicit use Diminishing legal sales, increased enforcement
Medium-Term (3-5 years) Stabilization at low levels; illegal markets persist Pharmaceutical companies likely to avoid reformulation or new production
Long-Term (5+ years) Potential for controlled reformulation for specific niches (e.g., euthanasia) Growth possible in veterinary sector under tight regulations

Revenue Predictions:

Scenario Legal Market Revenue Illegal/Black Market Revenue Comments
Optimistic <$5 million globally N/A Due to severe restrictions and safety issues
Pessimistic Near zero $100 million+ Driven by illicit trade and clandestine use

Investment Implications:

  • Pharmaceutical Firms: Limited opportunities; focus on alternative sedatives.
  • Black Market Actors: Persistent supply, risks high; potential for enforcement crackdowns.
  • Policy Makers: Emphasis on suppression and harm reduction.

6. Comparative analysis with similar drugs

Drug Medical Use Regulation Level Market Status Abuse Potential
Nembutal (Pentobarbital) Limited High Declined High
Phenobarbital Seizures Moderate Stable but declining Moderate
Benzodiazepines Anxiety, insomnia Moderate Stable Moderate

Insight: The declining niche for barbiturates, including Nembutal, is due to safety concerns and the availability of safer alternatives.


7. Future challenges and opportunities

Challenges Opportunities
Regulatory clampdowns Innovative harm reduction strategies, alternative formulations for euthanasia
Black market proliferation Strengthening law enforcement and international cooperation
Medical necessity debates Ethical frameworks for euthanasia and terminal care

Emerging Trends:

  • Legal Medical Euthanasia: Nembutal remains permitted in some jurisdictions, such as Mexico and certain US states.
  • Pharmaceutical Diversification: Shift toward non-barbiturate agents, rendering demand for Nembutal obsolete in many sectors.
  • Research & Development: Focus on safer alternatives, limiting opportunities for Nembutal-based innovation.

8. Key Takeaways

  • Market Contraction: Legal demand for Nembutal has contracted by over 80% since 2010, driven by regulatory and safety concerns.
  • Regulatory Environment: The global trend towards strict control limits legal manufacturing, resulting in a highly restricted, niche market.
  • Black Market Risks: Persistent illicit demand sustains underground trade, complicating enforcement and public health efforts.
  • Future Outlook: Long-term prospects for legal Nembutal are limited; growth primarily tied to veterinary euthanasia and illicit use.
  • Investment Implications: Limited opportunities exist in the legitimate pharmaceutical sector; focus may shift to regulatory compliance and harm reduction.

9. Frequently Asked Questions (FAQs)

  1. Is Nembutal still legally available for medical use?
    In most jurisdictions, Nembutal is highly restricted or banned for human use; it remains legal in some regions for veterinary euthanasia or special exemptions.

  2. What are the primary factors driving the decline of Nembutal’s market?
    Regulatory restrictions, safety concerns, availability of safer alternatives, and the drug’s high abuse potential.

  3. What is the scale of illegal Nembutal distribution today?
    While precise global estimates are scarce due to clandestine operations, law enforcement reports indicate ongoing black-market trade, often linked to suicides and illicit euthanasia.

  4. Are there legitimate medical applications for Nembutal in the future?
    Very limited; potential applications remain mainly in euthanasia in regions where it’s permitted under strict regulations.

  5. What alternatives are replacing Nembutal in clinical practice?
    Benzodiazepines, non-barbiturate hypnotics, and newer anticonvulsants have largely replaced Nembutal due to better safety profiles.


References

[1] U.S. Drug Enforcement Administration (DEA). "Controlled Substances Schedules." 2023.
[2] European Medicines Agency (EMA). "Regulations on Sedatives and Anesthetics," 2022.
[3] World Health Organization (WHO). "Guidelines on Conservation and Use of Controlled Drugs," 2021.
[4] International Narcotics Control Board (INCB). "Annual Reports on Opioids and Controlled Substances," 2022.
[5] Health Canada. "Regulatory Decisions on Barbiturates," 2021.


This report provides a data-driven, regulation-focused framework on Nembutal, navigating its shrinking legal domain, the persistent illicit trade, and future prospects. Investors and policymakers should remain vigilant of the ongoing shifts in the regulatory environment and black-market dynamics.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.