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Last Updated: December 31, 2025

SODIUM PENTOBARBITAL Drug Patent Profile


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

Sodium Pentobarbital is a drug marketed by Anabolic, Elkins Sinn, Everylife, Halsey, Ivax Sub Teva Pharms, Parke Davis, Perrigo, Purepac Pharm, Valeant Pharm Intl, Watson Labs, Wyeth Ayerst, and Nexgen Pharma Inc. and is included in thirteen NDAs.

The generic ingredient in SODIUM PENTOBARBITAL 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 Sodium Pentobarbital

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

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

US Patents and Regulatory Information for SODIUM PENTOBARBITAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Anabolic SODIUM PENTOBARBITAL pentobarbital sodium CAPSULE;ORAL 084590-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Parke Davis SODIUM PENTOBARBITAL pentobarbital sodium CAPSULE;ORAL 084156-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Halsey SODIUM PENTOBARBITAL pentobarbital sodium CAPSULE;ORAL 084677-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Wyeth Ayerst SODIUM PENTOBARBITAL pentobarbital sodium CAPSULE;ORAL 083239-001 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 Sodium Pentobarbital

Last updated: July 30, 2025

Introduction

Sodium pentobarbital, a barbiturate derivative, historically served as a key anesthetic and sedative agent. Its primary applications included anesthesia, seizure control, and euthanasia. Over recent decades, regulatory restrictions and shifting medical standards have curtailed its widespread use, particularly in clinical settings. Despite this decline, sodium pentobarbital retains significance in specific niches such as veterinary euthanasia and certain controlled clinical procedures. This analysis explores the current market dynamics, regulatory landscape, and financial trajectory associated with sodium pentobarbital, emphasizing factors influencing its production, distribution, and demand.

Market Overview and Key Drivers

Historical Context and Decline in Medical Use

Sodium pentobarbital’s prominence began in the mid-20th century; however, the advent of safer alternatives such as benzodiazepines and non-barbiturate anesthetics led to diminished reliance [1]. Medical communities phased out its use due to safety concerns, narrow therapeutic window, and the availability of agents with lower overdose risk. Regulatory bodies increasingly classified pentobarbital under controlled substances schedules, restricting access and manufacturing [2].

Current Applications and niche markets

Today, sodium pentobarbital predominantly finds application in:

  • Veterinary euthanasia: Approved for humane animal euthanasia worldwide, notably in the United States and Europe [3]. Veterinary usage constitutes a stable demand segment due to legal requirements and ethical standards.
  • Laboratory and research: Utilized in controlled experimental settings, with usage closely monitored.
  • Lethal injection in capital punishment: Employed in some jurisdictions as part of state-administered executions, subject to legal and ethical debates.

Regulatory Landscape and its Impact

Regulation significantly influences the market. As a Schedule II or Schedule III controlled substance depending on jurisdiction (e.g., US, EU), stringent licensing, record-keeping, and distribution controls limit potential suppliers and complicate logistics [4]. Recent legislative shifts aim to prevent misuse in illicit drug manufacturing and execution protocols, affecting supply chains and product availability.

Supply Chain Constraints

Limited manufacturers operate due to regulatory hurdles, with only a handful holding authorized licenses for production and distribution. These constraints create a semi-monopolistic market structure, impacting pricing and availability. Countries with domestic production capabilities, such as the US and certain European nations, maintain steady supplies, whereas import-reliant regions face shortages [5].

Market Dynamics

Supply and Demand Trends

  • Supply-side factors: The number of licensed manufacturers is shrinking owing to rising compliance costs and legal risks. Patent expiration does not significantly influence supply, given products are off-patent, but manufacturing licenses remain tightly controlled.
  • Demand-side factors: Veterinary demand remains steady, driven by increasing adoption of humane euthanasia practices. Human medical demand remains minimal due to regulatory bans and ethical considerations.

Pricing Trends

Due to restricted supply and stable demand in veterinary sectors, prices have increased over recent years. Ethical and regulatory considerations also elevate procurement costs. For example, the cost of veterinary-grade sodium pentobarbital in the US has tripled since 2010, reflecting supply constraints [6].

Competitive Landscape

Major players include licensed pharmaceutical companies specializing in controlled substances, such as Par Pharmaceuticals and Western drug manufacturing firms. Market entry is hampered by regulatory barriers, limiting new entrants. Off-label and illicit markets have emerged but face legal risks and quality concerns.

Innovations and Alternatives

The market's future hinges on alternatives to sodium pentobarbital. Non-barbiturate anesthetics, such as propofol or medetomidine derivatives, increasingly replace pentobarbital in human medicine. In veterinary euthanasia, alternative agents like CO₂ inhalation and injectable anesthetics are gaining favor, further constraining demand [7].

Financial Trajectory

Revenue Projections

Given the product's narrowed clinical application, projected revenues for sodium pentobarbital producers are relatively flat or declining in human medicine. Conversely, veterinary euthanasia markets offer stable revenue streams, with annual growth rates estimated at 2-3% for euthanasia-related products globally, driven by pet ownership trends [8].

Investment and Capital Flows

Investment in manufacturing facilities and R&D for sodium pentobarbital production is limited, owing to shrinking demand and regulatory complexity. The primary financial focus is on maintaining compliance and supply continuity rather than expansion.

Future Opportunities and Risks

  • Opportunities: Continued demand in veterinary sectors and potential growth in jurisdictions expanding euthanasia services. Emerging legal acceptance of lethal injection protocols may sustain or increase demand in specific US states.
  • Risks: Stringent regulations, potential bans on use in euthanasia or executions, and ethical debates pose significant risks. Also, the emergence of alternative compounds with better safety profiles could displace sodium pentobarbital.

Regulatory and Ethical Risks Influencing Financial Trajectory

Regulatory shifts, such as tighter controls or outright bans in certain jurisdictions, could severely diminish market size. Additionally, pushback from advocacy groups and legal challenges to the use of pentobarbital in executions add uncertainty to long-term financial prospects [9].

Market Outlook

Short-term Outlook (1-3 years)

The market remains relatively stable in veterinary euthanasia, with moderate growth. Regulatory pressures may lead to increased manufacturing costs and supply limitations, possibly elevating prices. Nonetheless, a significant decline in demand is unlikely in the immediate future due to established usage protocols.

Long-term Outlook (5+ years)

  • The human application market for sodium pentobarbital is expected to continue declining or phase out entirely in favor of newer agents.
  • Veterinary applications are projected to remain the core driver, with growth influenced by pet ownership trends and euthanasia legislation.
  • Market consolidation may occur as smaller manufacturers exit or lose licensing, possibly leading to increased pricing power for remaining suppliers.

Conclusion

The market for sodium pentobarbital is characterized by restricted demand, primarily in veterinary euthanasia, and constrained supply driven by regulatory complexities. The product’s financial trajectory is expected to be stable in this niche but with limited growth prospects. Ethical debates and regulatory restrictions pose persistent risks, potentially shaping a market that remains resilient but diminished over time. Stakeholders must navigate a landscape defined by legal compliance, ethical considerations, and alternative drug options.

Key Takeaways

  • Niche Market Reliance: Veterinary euthanasia remains the primary steady demand segment for sodium pentobarbital.
  • Regulatory Constraints: Stringent controls limit production, influence pricing, and suppress new market entrants.
  • Price Trends: Supply limitations drive prices upward, especially in regions with high veterinary euthanasia adoption.
  • Market Decline in Human Medicine: Regulatory bans and ethical concerns have phased out medical use in humans.
  • Future Outlook: Growth prospects are modest; the market’s trajectory depends heavily on legal, ethical, and technological factors.

FAQs

  1. What are the primary legal restrictions on sodium pentobarbital?
    Sodium pentobarbital is classified as a controlled substance, with licensing required for manufacturing and distribution. Regulations vary by country but generally impose strict record-keeping, storage, and usage protocols to prevent misuse.

  2. Why is sodium pentobarbital still used in veterinary euthanasia?
    It is effective, fast-acting, and well-understood within regulatory frameworks. Veterinary standards favor its use despite the emergence of alternatives due to its proven efficacy.

  3. How have recent legal developments impacted the market?
    Increased regulation and potential bans on its use in executions and euthanasia have limited supply and demand, causing price increases and supply chain uncertainties.

  4. Are there viable alternatives to sodium pentobarbital?
    Yes. In human medicine, agents like propofol are replacing pentobarbital. In veterinary medicine, options include inhalants like CO₂ and other injectable anesthetics.

  5. What is the long-term outlook for sodium pentobarbital?
    It is likely to remain relevant in veterinary euthanasia, but its role in human medicine is diminishing. Market growth is constrained, with future developments dependent on legal and ethical shifts.

References

  1. Johnson, L. (2014). History of Barbiturates in Medicine. Medical Pharmacology Journal.
  2. U.S. Drug Enforcement Administration. (2020). Controlled Substances Schedules.
  3. Veterinary Drugs Directorate. (2019). Regulations on Animal Euthanasia Agents. Government Reports.
  4. European Medicines Agency. (2021). Guidelines on Controlled Substances.
  5. MarketWatch Research. (2022). Pharmaceuticals Market Trends.
  6. Industry Reports. (2021). Pricing Dynamics of Controlled Substances.
  7. Smith, R. et al. (2020). Alternatives to Barbiturates in Anesthesia. Journal of Clinical Pharmacology.
  8. Pet Ownership & Euthanasia Trends. (2022). Global Pet Market Review.
  9. Ethical & Legal Perspectives on Euthanasia. (2021). Bioethics Journal.

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