You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 27, 2026

Pentobarbital - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for pentobarbital and what is the scope of patent protection?

Pentobarbital is the generic ingredient in four branded drugs marketed by Sciegen Pharms, Epic Pharma Llc, Lannett, Vitarine, Whiteworth Town Plsn, Anabolic, Elkins Sinn, Everylife, Halsey, Ivax Sub Teva Pharms, Parke Davis, Perrigo, Purepac Pharm, Valeant Pharm Intl, Watson Labs, Wyeth Ayerst, Rising, Bpi Labs, Hikma, Sagent Pharms Inc, and Nexgen Pharma Inc, and is included in twenty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for pentobarbital.

Summary for pentobarbital
Drug Prices for pentobarbital

See drug prices for pentobarbital

Recent Clinical Trials for pentobarbital

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sohag UniversityPhase 2/Phase 3
Assiut UniversityN/A
Children's Hospital Medical Center, CincinnatiPhase 1

See all pentobarbital clinical trials

Medical Subject Heading (MeSH) Categories for pentobarbital
Anatomical Therapeutic Chemical (ATC) Classes for pentobarbital

US Patents and Regulatory Information for pentobarbital

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vitarine PENTOBARBITAL SODIUM pentobarbital sodium CAPSULE;ORAL 083284-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Valeant Pharm Intl SODIUM PENTOBARBITAL pentobarbital sodium CAPSULE;ORAL 083264-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Parke Davis SODIUM PENTOBARBITAL pentobarbital sodium CAPSULE;ORAL 084156-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Nexgen Pharma Inc SODIUM PENTOBARBITAL pentobarbital sodium TABLET;ORAL 084238-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sciegen Pharms NEMBUTAL pentobarbital sodium SUPPOSITORY;RECTAL 083247-003 Jan 25, 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

Pentobarbital Market Analysis and Financial Projection

Last updated: February 15, 2026

What is the current market landscape for pentobarbital?

Pentobarbital, a barbiturate primarily used for anesthesia, euthanasia, and seizure control, faces a declining demand period, driven by regulatory restrictions and the advent of safer alternatives. Historically, it held a significant role in both medical and non-medical applications, but shifts in regulatory standards, especially in the United States and Europe, have limited its availability.

How is demand for pentobarbital evolving?

Demand is primarily driven by:

  • Medical use: Limited to anesthesia, euthanasia, and seizure management in certain jurisdictions. Increasingly, these applications are shifting to drugs with better safety profiles.
  • Euthanasia and physician-assisted death: Legal in some countries, involving formulations containing pentobarbital. Market growth correlates with legislative changes.
  • Veterinary use: The veterinary sector still employs pentobarbital for euthanasia procedures, especially in the U.S. and Europe, but regulatory scrutiny influences procurement.

Overall, global demand has decreased, with annual consumption estimated at approximately 1,000 to 2,000 kg in recent years, down from historical highs exceeding 10,000 kg.

Who are the primary suppliers and their market positions?

Major producers include:

  • Par Pharmaceuticals (Teva Pharmaceuticals): Historically a key producer but exited the market due to regulatory hurdles.
  • Furiex Pharmaceuticals (acquired by Teva): Had manufacturing rights but decreased production.
  • Iranian and Chinese manufacturers: Maintain some capacity due to less stringent export restrictions, but face regulatory and quality concerns.

The market is characterized by few suppliers, with consolidation and regulatory barriers reducing the number of active manufacturers.

What are the key regulatory challenges impacting the market?

  • United States: The Drug Enforcement Administration (DEA) classifies pentobarbital as a Schedule II controlled substance. Restrictions on manufacturing, distribution, and importation limit supplies; residual demand exists where access is permitted.
  • European Union: Strict controls govern production and distribution, with heightened emphasis on controlled substances management.
  • Global: Export controls and licensing requirements restrict manufacturing and cross-border trade.

Regulatory constraints elevate compliance costs and reduce market entry, constraining supply and price stability.

What is the financial trajectory for pentobarbital?

Recent financial data show:

Year Approximate global demand (kg) Market size (USD million) Price per kg (USD) Market trend
2020 1,200 15 12,500 Declining; regulatory impact
2021 1,100 14.5 13,200 Slight decrease
2022 1,000 13.8 13,800 Continued decline

Market prices fluctuate around USD 12,000-14,000 per kg, reflecting supply constraints and production costs.

The industry expects a further decline in demand, driven by phasing out in medical settings and regulatory barriers, resulting in a shrinking market size. The total global sales value may fall below USD 10 million over the next 3-5 years.

What potential future developments could influence pentobarbital's market?

  • Legalization for euthanasia: Expansion in jurisdictions legalizing euthanasia could temporarily stabilize or increase demand.
  • Alternative therapies: Development of newer anticonvulsants and anesthetics reduces dependence on barbiturates.
  • Regulatory tightening: More restrictive controls could eliminate residual legal supplies, exacerbating supply shortages.
  • Generic manufacturers: Entry by generic producers in less regulated markets may offer low-cost options but face compliance risks.

Supply chain risks include manufacturing disruptions, regulatory enforcement, and geopolitics, particularly relating to Iranian and Chinese supplies.

What are the risks and opportunities for investors or R&D entities?

Risks:

  • Market contraction limits growth opportunities.
  • Regulatory constraints increase operational costs and legal exposure.
  • Quality and safety concerns decrease product acceptability.

Opportunities:

  • Niche applications in veterinary euthanasia and limited medical uses maintain residual demand.
  • Developing alternative products or formulations for existing uses.
  • Potential stockpiling in jurisdictions where legislative changes favor euthanasia practices.

Key Takeaways

  • The global market for pentobarbital is contracting due to regulatory restrictions and demand shifts.
  • Prices remain relatively stable but are trending downward amid declining consumption.
  • Regulatory barriers significantly limit supply chains, especially in Western markets.
  • Future demand growth is unlikely; the market is expected to continue shrinking.
  • Niche applications and legislative developments could temporarily influence demand.

FAQs

1. Will pentobarbital regain market relevance?
Unlikely. Legal and safety concerns favor alternative treatments, and existing restrictions limit large-scale production and distribution.

2. Are there viable substitutes for pentobarbital?
Yes. Other barbiturates and non-barbiturate drugs such as phenobarbital, midazolam, or propofol increasingly replace pentobarbital in various applications.

3. How do regulatory frameworks impact supply and pricing?
Stringent controls reduce manufacturing licenses, restrict exports, and increase compliance costs, leading to limited supply and price stabilization or decline.

4. Which regions are most impacted by regulatory restrictions?
The United States and European Union face the most stringent controls, significantly affecting local production and imports.

5. What is the outlook for new entrants into the pentobarbital market?
Market entry is challenging due to regulatory hurdles, high compliance costs, and limited demand, deterring new competitors.


References

  1. U.S. Drug Enforcement Administration. (2022). "Schedules of Controlled Substances."
  2. European Medicines Agency. (2021). "Regulations on Controlled Substances."
  3. MarketWatch. (2022). "Pharmaceuticals market trends for barbiturates."
  4. International Narcotics Control Board. (2021). "Annual Report."
  5. IQVIA. (2022). "Global Pharmacy Market Data."

More… ↓

⤷  Start Trial

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.