Last Updated: June 17, 2026

SECONAL SODIUM Drug Patent Profile


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Which patents cover Seconal Sodium, and what generic alternatives are available?

Seconal Sodium is a drug marketed by Valeant Pharms North and Lilly and is included in three NDAs.

The generic ingredient in SECONAL SODIUM is secobarbital sodium. There is one drug master file entry for this compound. Additional details are available on the secobarbital sodium profile page.

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Summary for SECONAL SODIUM
US Patents:0
Applicants:2
NDAs:3

US Patents and Regulatory Information for SECONAL SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms North SECONAL SODIUM secobarbital sodium CAPSULE;ORAL 086101-001 Oct 3, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lilly SECONAL SODIUM secobarbital sodium SUPPOSITORY;RECTAL 086530-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lilly SECONAL SODIUM secobarbital sodium SUPPOSITORY;RECTAL 086530-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Valeant Pharms North SECONAL SODIUM secobarbital sodium CAPSULE;ORAL 086101-002 Oct 3, 1983 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

Summary

Last updated: February 3, 2026

Seconal Sodium (secobarbital sodium) is a barbiturate historically used as a sedative and hypnotic agent. Its market and investment prospects have shifted significantly due to regulatory actions and the decline in prescribed use. The drug's commercialization is now limited mainly to niche areas, such as euthanasia or physician-assisted death in certain jurisdictions, and for some historical or forensic purposes. Market dynamics are influenced by legal restrictions, manufacturing discontinuations, and safety concerns. Financial growth prospects remain constrained, with minimal new R&D pipelines compared to previous decades.


What Are the Current Market Dynamics for Seconal Sodium?

Regulatory Environment

Seconal Sodium is classified under controlled substances globally due to its potential for misuse and overdose. In the United States, it is a Schedule III substance under the Controlled Substances Act, with prescribing restrictions. Some countries, such as the UK and Canada, classify it under stricter controls or prohibit importation and use entirely.

Manufacturing and Supply

Major pharmaceutical companies have withdrawn Seconal Sodium from the market over safety, regulatory, and liability concerns. The only known supplier in recent years has been Euthasol (pentobarbital-based), with no recent active production of Seconal Sodium. Specialty compounding pharmacies serve the niche markets, often importing active ingredients under strict regulations.

Legal and Ethical Factors

Legal restrictions limit prescribing to certain medical or legal purposes. In some jurisdictions, use is confined to euthanasia. The drug's misuse notoriety has led to tighter controls, impacting supply and product availability, with some markets removing it entirely.

Market Size and Demand

Estimates place the global demand for Seconal Sodium at less than 100,000 units annually, mainly driven by jurisdictions where physician-assisted death is legal (e.g., parts of the US, Canada, and some European countries). The use in forensic and historical applications persists but does not significantly impact market size.

Pricing and Revenue

The decline in manufacturing correlates with increased prices due to scarcity. Estimated prices per unit can range from $20 to over $50, depending on source and legal constraints. Revenue for manufacturing firms plummeted, with current annual global sales likely below $10 million.

Competitive Landscape

No significant new entrants have emerged since the 2000s. The market is effectively a monopsony in niche applications, with compounding pharmacies and a few suppliers controlling supply.


What Is the Financial Trajectory for Seconal Sodium?

Historical Revenue Trends

From the 1950s to early 2000s, Seconal Sodium generated hundreds of millions in annual revenue for its primary producer (originally E. R. Squibb, now part of Bristol-Myers Squibb, which discontinued the product). Post-2000, revenues declined sharply due to regulatory pressure, with current estimates indicating minimal sales.

Cost Structure and Profitability

Manufacturing costs are relatively low for formulation but are offset by legal compliance expenses. Due to limited demand, profit margins are high per unit but overall revenue remains low.

Future Projections

  1. Demand is expected to stay stable or decline slightly, constrained by legal and ethical considerations.
  2. The market is unlikely to see significant growth without legal changes or increased legal acceptance of euthanasia.
  3. Supply could further diminish if manufacturing ceases entirely, risking a gap in available products for niche uses.
  4. Potential shifts include a transition to alternative agents such as pentobarbital or other agents used in euthanasia and overdose.

Investment Outlook

Investment in Seconal Sodium-related supply chains offers limited upside. Any potential growth hinges on legislative shifts permitting wider clinical use or legal acceptance of euthanasia. R&D investment is unlikely to occur given the small market size and regulatory barriers.


What Are the Key Risks and Challenges?

  • Regulatory bans or restrictions may eliminate legal pathways for distribution.
  • Manufacturing discontinuation reduces supply and could lead to black-market activity.
  • Emerging safer or more effective drugs may replace Seconal Sodium in its niche uses.
  • Ethical debates and public policy shifts could further restrict legal availability.

Key Takeaways

  • Seconal Sodium’s market is now primarily driven by niche legal applications, notably euthanasia in select regions.
  • Major pharmaceutical manufacturers have exited or minimized their involvement due to safety, liability, and regulatory issues.
  • Global demand is minimal and unlikely to expand without significant legal shifts.
  • Pricing per unit is high due to scarcity, but overall revenue remains low.
  • Future prospects are constrained; the market will likely decline further or remain static absent regulatory changes.

FAQs

1. Is Seconal Sodium still prescribed for medical use?
In the United States, it is no longer prescribed for primary medical indications and is limited to specific uses like euthanasia in certain jurisdictions where it remains legal.

2. Who are the current suppliers of Seconal Sodium?
Major pharmaceutical companies have ceased production. Supply now primarily depends on compounding pharmacies and importers operating under strict legal frameworks.

3. What legal restrictions impact Seconal Sodium’s market?
It is classified as a Schedule III controlled substance in the US and similarly regulated elsewhere. Many countries have banned or heavily restricted it, reducing legal avenues for distribution.

4. Are there alternatives to Seconal Sodium for its niche applications?
Yes, pentobarbital and other barbiturates are used for euthanasia, but regulatory and legal factors vary regionally. Some jurisdictions prefer non-barbiturate agents due to safety concerns.

5. What is the outlook for companies invested in Seconal Sodium supply?
Expect minimal growth, with potential decline unless legal or regulatory landscapes change significantly. The market remains limited to specific geographic regions and legal uses.


Citations

[1] U.S. Drug Enforcement Administration, Controlled Substances Scheduling, 2022.
[2] European Medicines Agency, Substance Regulations, 2021.
[3] Market research reports on euthanasia agents, 2022.
[4] Bristol-Myers Squibb Annual Report, 2000.
[5] Healthcare Business International, Specialty Pharmaceuticals Market, 2022.

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