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Last Updated: December 14, 2025

NEMBUTAL SODIUM Drug Patent Profile


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Which patents cover Nembutal Sodium, and when can generic versions of Nembutal Sodium launch?

Nembutal Sodium is a drug marketed by Epic Pharma Llc and Rising and is included in four NDAs.

The generic ingredient in NEMBUTAL SODIUM is pentobarbital sodium. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pentobarbital sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Nembutal Sodium

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

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Summary for NEMBUTAL SODIUM
Drug patent expirations by year for NEMBUTAL SODIUM

US Patents and Regulatory Information for NEMBUTAL SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Epic Pharma Llc NEMBUTAL SODIUM pentobarbital sodium CAPSULE;ORAL 084095-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Rising NEMBUTAL SODIUM pentobarbital sodium INJECTABLE;INJECTION 083246-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  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
>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 SODIUM

Last updated: July 28, 2025

Introduction

Nembutal Sodium, the sodium salt of pentobarbital, is a barbiturate historically used as an anesthetic and sedative. Though its clinical use has declined due to safety concerns and tighter regulations, it retains relevance in various biological research and, in some jurisdictions, controlled medicinal contexts. This report examines the current market dynamics and financial trajectory of Nembutal Sodium, considering regulatory shifts, manufacturing landscapes, legal constraints, and emerging demand sectors.

Regulatory Environment and Impact on Market Dynamics

Legal Restrictions and Control Measures

Nembutal Sodium’s classification as a Schedule II controlled substance in the United States and equivalent restrictive categories worldwide has significantly shaped its market trajectory. Regulatory bodies, including the DEA, enforce strict manufacturing, distribution, and usage controls, primarily due to its potential misuse in lethal injections and suicides. These restrictions have curtailed production, dissuaded new entrants, and elevated compliance costs.

In jurisdictions where it remains medically relevant, such as certain countries permitting euthanasia or assisted suicide under stringent conditions, regulatory frameworks continue to influence demand. For example, in countries like Germany and Australia, its use is limited but permissible under controlled circumstances, influencing regional market variations.

Impact of Legal Prohibitions on Supply Chain

Stringent regulations have caused supply chain limitations, with manufacturers often operating under restricted licenses. The scarcity of genuine Nembutal Sodium formulations—especially authentic and WHO-verified products—drives a black-market for illicit procurement. This underground trade complicates regulatory enforcement and impacts market transparency, thereby affecting the financial stability of legitimate producers.

Market Participants and Manufacturing Landscape

Key Manufacturers

Historically, major pharmaceutical providers such as Lundbeck and other global generic manufacturers produced Nembutal Sodium. However, many have ceased manufacturing owing to regulatory complications and low commercial profitability. As a result, a limited number of specialized or clandestine entities have preserved production, often operating outside formal regulatory channels.

Manufacturing Costs and Market Entry Barriers

The production of Nembutal Sodium requires sophisticated chemical synthesis capabilities, adherence to strict safety protocols, and licensing compliance. These high barriers have decreased the number of active producers, consolidating the market among a few entities. The costs associated with compliance and potential legal liabilities have further constrained formal market expansion.

Demand Dynamics

Medical and Research Applications

While the use of Nembutal Sodium as an anesthetic has declined sharply due to safety concerns, it remains relevant in niche research settings involving animal studies and pharmacological investigations. Nonetheless, this demand is highly regulated and relatively stable but limited in volume.

Euthanasia and End-of-Life Practices

In countries where euthanasia is legal under strict conditions, Nembutal Sodium is occasionally used as part of lethal injection protocols or assisted dying procedures. However, the decline of proprietary drug brands in favor of other formulations and increased regulatory scrutiny has led to a decreased and unpredictable demand.

Illicit Use and Black Market

The illegal trade of Nembutal Sodium for suicides or clandestine euthanasia contributes significantly to black-market demand, especially in regions with restrictive legal environments. This illicit market can fluctuate based on law enforcement activities, supply shortages, and social factors influencing suicide rates.

Technological and Market Trends

Alternatives and Substitutes

The development of alternative sedative-hypnotics—such as benzodiazepines like diazepam, and non-barbiturate anesthetics—has reduced reliance on Nembutal Sodium in clinical settings. Additionally, the rise of safer and more predictable agents hampers the growth prospects for Nembutal Sodium.

Emerging Scientific and Pharmaceutical Uses

While its primary uses are declining, current research exploring novel applications, such as in neurologic studies or as a component in specific drug formulations, has the potential to influence niche demand levels. Nonetheless, regulatory hurdles and safety concerns limit substantial market growth.

Financial Trajectory and Future Outlook

Pricing Trends and Revenue Potential

Due to scarcity, illicit markets have reported inflated prices for genuine Nembutal Sodium, often driven by black-market dynamics. Legitimate supplies have experienced declining revenues, constrained by regulatory compliance costs and limited demand.

Market Expansion Prospects

Officially, prospects for expansion appear bleak owing to regulatory constraints and technological obsolescence. The narrow scope of permissible medical applications diminishes growth momentum. Conversely, clandestine markets may experience short-term fluctuations tied to enforcement actions and societal trends.

Investment Considerations

Any direct investment into Nembutal Sodium manufacturing remains high-risk, subject to legal and ethical considerations. Indirect exposure through companies involved in regulated drug research or alternative sedative development might present more sustainable avenues.

Regulatory-Driven Market Contraction

Globally, ongoing legal tightening, especially in North America and Europe, predicts sustained market contraction, with a focus on reducing misuse, which directly impacts market viability and profit margins.

Impact of Public Perception and Ethical Debates

Public sentiment against controlled substances associated with assisted suicide, euthanasia, and misuse influences policy and market environment. Heightened ethical debates often lead to legislative restrictions, further constraining supply and demand.

Conclusion

The market dynamics for Nembutal Sodium are characterized by regulatory shrinkage, declining clinical use, and a substantial illicit trade. Its financial trajectory is predominantly downward or stagnant, hindered by legal, ethical, and technological factors. Industry stakeholders are advised to monitor policy shifts closely, particularly concerning euthanasia regulations, drug safety trends, and enforcement actions affecting supply chains.


Key Takeaways

  • Regulatory clout dominates: Stringent legal controls have diminished formal manufacture and usage, constraining market expansion and elevating illicit trade risks.
  • Limited clinical demand: Safety concerns have led to obsolescence in primary medical applications, with niche research being the sole legitimate demand source.
  • Market consolidation: Few licensed producers operate globally, increasing dependence on clandestine sources and complicating market transparency.
  • Pricing and profitability: Scarcity and illicit trade inflate prices; legitimate revenues are declining due to diminished clinical use and regulatory barriers.
  • Future outlook: Regulatory tightening and public ethical debates are likely to suppress market growth; niche scientific uses may offer limited alternative revenue streams.

FAQs

1. What regulatory classifications impact Nembutal Sodium globally?
Nembutal Sodium is classified as a Schedule II substance in the U.S. and similarly controlled in many countries, limiting legal production, distribution, and usage. These classifications have significantly restricted market growth and facilitated illicit trade.

2. Are there legitimate medical uses for Nembutal Sodium today?
Medical use has nearly ceased in most jurisdictions because of safety concerns and availability of safer alternatives. In some regions, it remains legally permissible for euthanasia or specific veterinary procedures under controlled circumstances.

3. How does illicit trade influence the market landscape?
Illicit markets inflate prices, supply shortages, and create legal risks for consumers and distributors. This shadow economy obscures true market size, hampers regulation, and impacts legitimate industry players.

4. What are the prospects for future demand?
Future demand is expected to remain limited, primarily confined to niche research. Legal restrictions and the availability of alternative agents diminish commercial prospects for Nembutal Sodium.

5. Can technological advancements revive Nembutal Sodium’s market?
Current technological trends favor novel sedatives and anesthetics with better safety profiles and regulatory acceptance. Therefore, breakthroughs are unlikely to significantly restore Nembutal Sodium’s market unless significant regulatory reforms occur.


Sources:

[1] U.S. Drug Enforcement Administration (DEA). “Controlled Substances Act Scheduling.”
[2] World Health Organization. “Global Report on Drug Usage.”
[3] European Medicines Agency. “Pharmacovigilance and Drug Regulation Reports.”
[4] Industry analyses on pharmaceutical manufacturing barriers and market consolidation.
[5] Academic journals on illicit drug trade and public health impacts.

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