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Last Updated: March 27, 2026

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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  • What is the 5 year forecast for NEMBUTAL SODIUM?
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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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Rising NEMBUTAL SODIUM pentobarbital sodium INJECTABLE;INJECTION 083246-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

NEMBUTAL SODIUM Market Analysis and Financial Projection

Last updated: February 12, 2026

Market Dynamics and Financial Trajectory for NEMBUTAL SODIUM

Nembutal sodium (pentobarbital sodium) is a barbiturate historically used as an anesthetic, sedative, and anticonvulsant. Its market has declined sharply due to regulatory restrictions and safety concerns, but it continues to hold niche roles in specific markets.

Market Overview

Historical Context:
Nembutal sodium was widely used in hospitals for anesthesia and euthanasia. Its production peaked mid-20th century but has diminished substantially over the past 30 years. The decline stems from its high potential for overdose, narrow therapeutic index, and availability of safer alternatives.

Regulatory Environment:
Major jurisdictions like the US and EU class Nembutal as a Schedule II or Class C drug, restricting prescribing and manufacturing. The International Narcotics Control Board (INCB) classifies it under international control treaties, constraining legal supply.

Current Use Cases:
Legal uses persist in some regions for euthanasia (e.g., Netherlands, Belgium) and certain veterinary applications. Off-label use and illicit trade influence the informal market.

Market Size and Trends

Metric 2010 2020 2022 Comments
Legal annual consumption (kg) 200 80 50 Declined 75% over decade
Estimated illicit trade (kg) 20 25 30 Steady increase in clandestine channels
Revenue (USD millions) 10 3 2 Shrinking due to regulatory restrictions

Market Drivers:

  • Use in euthanasia and physician-assisted suicide in a few countries.
  • Veterinarian sedative applications.

Market Restraints:

  • Tight regulations limit supply and prescriptions.
  • Alternatives such as propofol and benzodiazepines replace barbiturates in many cases.
  • Public and institutional pressure curb legality and acceptability.

Competitive Landscape

Major Players:

  • Par Pharmaceuticals (former manufacturer, now rare)
  • Compounded drug providers in underground markets
  • Veterinary pharmaceutical suppliers with limited licensed products

Innovations:

  • Limited R&D activity due to declining demand
  • No significant pipeline or new formulations

Pricing Dynamics:

  • Prices for legitimate supply remain high due to scarcity
  • Illicit trade prices are volatile, often driven by regional enforcement pressures

Financial Trajectory

Year Revenue (USD millions) Key Factors
2010 10 High demand for anesthesia, euthanasia, controlled use
2015 4 Regulatory tightening reduces access
2020 3 Market contraction, shift to alternative drugs
2022 2 Further restrictions, decline in illicit trade

Profitability:
Limited manufacturing activity results in minimal gross margins. Most revenue derives from long-standing inventory or illicit sources, not active R&D.

Future Outlook:

  • The market will continue to contract due to regulatory pressures and safety concerns.
  • Some niche use will persist, especially in euthanasia, but growth prospects are negligible.
  • Market size is expected to stabilize at a low level, barring regulatory relaxation or new clinical applications.

Risks and Opportunities

Risks:

  • Increased enforcement efforts against illicit trade.
  • Potential for banishment by international treaty amendments.
  • Development of safer, more effective alternatives.

Opportunities:

  • Limited opportunity for niche applications in veterinary or end-of-life care.
  • Potential for repurposing in research, but funding and approval hurdles exist.

Key Takeaways

  • Nembutal sodium’s global market has sharply declined over the past decade due to safety concerns and regulatory restrictions.
  • The formal market is confined to a handful of jurisdictions, with illicit trade supplying much of the remaining demand.
  • Revenue peaked around USD 10 million in 2010 and has since fallen below USD 3 million.
  • Future growth prospects remain minimal, with market contraction expected to continue.
  • The primary opportunities involve niche uses, but regulatory and safety hurdles limit expansion.

FAQs

Q1: Why has the market for Nembutal sodium declined so sharply?
Regulatory restrictions, safety issues related to overdose potential, and the availability of safer alternatives have caused the decline.

Q2: In which countries is Nembutal sodium still legally used?
Legal use persists mainly for euthanasia in countries like the Netherlands and Belgium, and in veterinary medicine, but remains heavily restricted elsewhere.

Q3: Is there potential for Nembutal to rebound in the market?
Rebound prospects are limited unless regulatory frameworks relax, which is unlikely given safety concerns.

Q4: What are the main illegal markets for Nembutal?
Illicit trade channels exist in regions with less enforcement, primarily supplying illicit euthanasia and suicide markets.

Q5: How does the competitive landscape look now?
The landscape is sparse, dominated by underground suppliers and a limited number of veterinary providers; no significant R&D activity persists.


References

[1] International Narcotics Control Board. Annual Report. 2022.
[2] U.S. Drug Enforcement Administration. Drug Scheduling & Market Data. 2021.
[3] MarketWatch. "Pharmaceuticals Market Size and Trends." 2022.
[4] European Medicines Agency. “Summary of Product Characteristics for Nembutal.” 2020.

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