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

Last Updated: December 17, 2025

NEMBUTAL Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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 Inc NEMBUTAL pentobarbital ELIXIR;ORAL 083244-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Epic Pharma Llc NEMBUTAL SODIUM pentobarbital sodium CAPSULE;ORAL 084093-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sciegen Pharms Inc NEMBUTAL pentobarbital sodium SUPPOSITORY;RECTAL 083247-003 Jan 25, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Epic Pharma Llc NEMBUTAL SODIUM pentobarbital sodium CAPSULE;ORAL 083245-001 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 NEMBUTAL (Pentobarbital)

Last updated: July 29, 2025

Introduction

NEMBUTAL, containing the active ingredient pentobarbital, is a barbiturate historically utilized as a sedative, hypnotic, and anticonvulsant. Despite its declining medical usage, NEMBUTAL has retained significance in alternative domains, notably in euthanasia and capital punishment, while its regulatory status profoundly influences its market and financial trajectory. This report offers an in-depth analysis of the current market dynamics and anticipated financial pathways surrounding NEMBUTAL, considering regulatory, legal, clinical, and geopolitical factors.

Market Overview

Historical Context and Medical Use

Introduced in the early 20th century, NEMBUTAL gained prominence as a sedative and anesthetic agent. It was widely prescribed until the advent of benzodiazepines and other safer alternatives. Today, its clinical application is largely limited, with some international jurisdictions still utilizing pentobarbital for euthanasia and assisted suicide—mainly under strict legal supervision.

Regulatory Status and Its Impact on Market Access

Regulatory constraints are the primary drivers of NEMBUTAL’s market contraction. In the US, the Drug Enforcement Administration (DEA) classifies pentobarbital as a Schedule II controlled substance, imposing strict production, prescribing, and distribution regimes. European countries have similarly restricted its medical use, mainly prescribing it for terminal sedation or euthanasia under specific legal frameworks.

Global Supply Dynamics: Few manufacturers produce pharmaceutical-grade pentobarbital due to strict controls and potential legal liabilities. This limited supply often results in high prices, especially in markets where it is used for euthanasia procedures. The supply chain’s fragility makes the drug susceptible to regulatory crackdowns, influencing market stability and growth prospects.

Ethical and Legislative Factors

Euthanasia laws vary significantly across jurisdictions. Countries like the Netherlands, Belgium, and Canada permit medically-assisted death using pentobarbital-based formulations, fostering a niche but growing demand. Conversely, regions with stringent anti-euthanasia legislation, such as many US states and Asian nations, effectively eliminate legitimate market avenues. Legislative shifts, therefore, are key determinants of future market trajectories.

Alternative and Competing Agents

The rise of alternative agents diminishes NEMBUTAL’s clinical relevance. For euthanasia, drugs like pancuronium and sodium thiopental have historically competed with pentobarbital but are increasingly restricted or unavailable. The decreasing acceptance and availability of such drugs further marginalize NEMBUTAL’s commercial prospects.

Financial Trajectory Analysis

Current Revenue Streams

The primary current revenue for NEMBUTAL stems from:

  • Specialty euthanasia providers: In select regions with permissive laws.
  • Pharmaceutical compounding: Vertical integration of compounding pharmacies in jurisdictions permitting its use.
  • Research and forensic applications: Limited demand persists for analytical purposes and research, though substantially smaller.

Market Challenges

Regulatory Restrictions: The primary challenge is regulatory. Many countries have limited or banned manufacturing or prescribing of pentobarbital for non-laboratory or euthanasia use, significantly constraining market size.

Legal Risks and Liability: Medical providers and pharmacies face legal liability when dispensing pentobarbital outside strictly permitted contexts, further constraining demand.

Supply Chain Limitations: Few manufacturers maintain large inventories, often manufacturing only for existing legal markets. Any disruption significantly impacts supply stability.

Growth Opportunities and Future Trends

Legal Expansion in Euthanasia: Countries expanding euthanasia laws may create new, albeit limited, markets—for example, the recent legalization of assisted dying in several US states (e.g., California, Colorado) fuels potential demand.

Regulatory Relaxation: Any policy shift toward broader acceptance of euthanasia or palliative sedation could revive the drug's market. However, such shifts face significant ethical and political opposition.

Alternative Formulations: Development of formulations enabling less invasive or more controlled administration may open niche markets, although regulatory hurdles remain.

Market Exit or Decline: Given decreasing clinical use, coupled with stringent controls, the outlook trends toward obsolescence outside niche markets. A major decline is expected unless new legal frameworks or indications emerge.

Key Market Players

  • tradiitional pharmaceutical companies—notably former producers of pentobarbital, such as Lundbeck and Par Pharmaceutical—have largely exited or restricted their production.
  • Compounding pharmacies—play a significant role, especially in jurisdictions permitting compounded formulations for euthanasia, though regulatory scrutiny increases.
  • Forensic and research organizations—use residual quantities for analytical purposes, but their market share remains marginal.

Geopolitical and Ethical Influences

International divergence in euthanasia legislation dictates market accessibility. Europe leads in legal acceptance, with countries like the Netherlands and Belgium actively using pentobarbital-based protocols. Conversely, strict anti-euthanasia policies in Asia and the US suppress market opportunities, stifling growth prospects.

Ethical debates surrounding assisted dying impact market stability domestically and internationally. Advocacy for expanding euthanasia laws could temporarily bolster demand, yet opposition risks imposing stricter bans or controls.

Future Outlook and Investment Considerations

The overall outlook for NEMBUTAL is cautious. The drug’s decline in clinical utility, coupled with extensive regulation and ethical controversy, constrains its market to specific legal niches. Short-term opportunities exist within jurisdictions expanding euthanasia legislation, but long-term prospects appear limited.

Investors should consider:

  • Regulatory environment volatility
  • Limited supply sources
  • Growing legal restrictions
  • Ethical debates

Potential avenues for growth are outweighed by the risk of market attrition, suggesting that NEMBUTAL’s financial trajectory is predominantly downward unless significant legal or clinical developments occur.

Key Takeaways

  • Regulatory and legal restrictions are the dominant factors constraining NEMBUTAL’s market growth, maintaining its status as a niche product.
  • Evolving euthanasia laws present potential, but uncertain, growth opportunities limited to specific jurisdictions.
  • Supply chain limitations and legal liabilities pose significant risks, making the drug increasingly obsolete in mainstream medicine.
  • Market decline is anticipated in the absence of new indications, formulations, or policy shifts.
  • Investors should exercise caution, considering ethical, legal, and geopolitical factors influencing the drug’s future.

FAQs

1. What are the primary uses of NEMBUTAL today?
Primarily, NEMBUTAL is used in euthanasia procedures and, in some regions, as an anesthetic agent for veterinary purposes. Its clinical use in human medicine has sharply declined, restricted by regulatory controls.

2. Why has the market for NEMBUTAL diminished?
The decline results from stricter regulations, availability of alternative agents, ethical debates around euthanasia, and the risk of legal liabilities, leading to limited supply and demand.

3. Are there emerging markets or legal changes that could expand NEMBUTAL's use?
Some jurisdictions expanding euthanasia laws could marginally increase demand. However, legislative debates and ethical considerations typically temper market growth prospects.

4. How does regulatory status affect the financial prospects of NEMBUTAL?
Regulatory restrictions limit manufacturing, distribution, and prescribing, significantly restricting potential revenue streams and precipitating a downward trajectory.

5. Are alternative drugs replacing NEMBUTAL in its traditional applications?
Yes. Drugs like sodium thiopental and pancuronium have taken over some roles, but increasing restrictions on these agents concurrently diminish their market as well.


References

  1. [1] U.S. Drug Enforcement Administration (DEA). Schedule II controlled substances.
  2. [2] European Medicines Agency (EMA). Regulations concerning scheduled drugs.
  3. [3] World Health Organization (WHO). Guidelines on euthanasia and palliative sedation.
  4. [4] Legal statutes on euthanasia in the Netherlands, Belgium, and Canada.
  5. [5] Industry reports on pharmaceutical manufacturing and supply chain dynamics.

More… ↓

⤷  Get Started Free

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.