PENTOTHAL Drug Patent Profile

When do Pentothal patents expire, and what generic alternatives are available?

Pentothal is a drug marketed by Abbott and is included in one NDA.

The generic ingredient in PENTOTHAL is thiopental sodium. There are four drug master file entries for this compound. Additional details are available on the thiopental sodium profile page.

Summary for PENTOTHAL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	3
Patent Applications:	1,734
DailyMed Link:	PENTOTHAL at DailyMed

Recent Clinical Trials for PENTOTHAL

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

Sponsor	Phase
Saint Vincent's Hospital, Korea	N/A
TC Erciyes University	Phase 4
Oslo University Hospital	Phase 4

See all PENTOTHAL clinical trials

US Patents and Regulatory Information for PENTOTHAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbott	PENTOTHAL	thiopental sodium	SUSPENSION;RECTAL	011679-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Overview of PENTOTHAL Market Dynamics and Financial Trajectory

Last updated: February 9, 2026

Pentothal (thiopental sodium) is a barbiturate primarily used as an anesthetic induction agent. Its market has experienced shifts driven by regulatory changes, safety concerns, and industry trends toward alternative anesthetic agents.

Market Size and Historical Trends

• Global Market Valuation: The anesthetic agents market valued over $8 billion in 2022, with PENTOTHAL comprising a significant share historically. The exact proportion of PENTOTHAL's market size is uncertain due to declining prescriptions.
• Usage Decline: PENTOTHAL's use has decreased by approximately 60% between 2012 and 2022, largely displaced by newer agents such as propofol.

Key Market Drivers

• Regulatory Restrictions: The U.S. FDA banned PENTOTHAL as a single-use injectable in 2011 due to contamination concerns and manufacturing issues.[1]
• Legal and Ethical Considerations: The drug's association with executions in some jurisdictions influences its market access.
• Safety Profile: The narrow therapeutic index and risk of respiratory depression restrict use to controlled environments, limiting off-label prescriptions.
• Alternatives: Propofol and other agents offer improved safety and ease of administration, reducing PENTOTHAL’s market share.

Supply Chain and Manufacturing

• Manufacturers: Few companies produce pharmaceutical-grade thiopental sodium currently; outdated manufacturing facilities have led to supply shortages.
• Regulatory Barriers: The Drug Enforcement Administration (DEA) controls importation and distribution in the U.S., complicating global supply dynamics.
• Import Restrictions: U.S. import restrictions limit availability, but ongoing pharmaceutical manufacturing in some countries (e.g., India, China) ensures continued supply elsewhere.

Financial Trajectory

• Revenue Decline: Industry estimates suggest a decline in global PENTOTHAL sales from approximately $100 million in 2010 to less than $30 million in 2022.
• Pricing: Market prices have stabilized around $1.50-$3.00 per vial, but fluctuated due to supply shortages and regulatory hurdles.
• Research and Development: No significant R&D investments currently target PENTOTHAL as a primary market, given its declining use.

Regulatory and Legal Environment

• FDA Regulations: The 2011 ban curtailed U.S. production and prompted reliance on imports.
• Controlled Substance Schedule: Thiopental sodium is classified as a Schedule III narcotic in the U.S., impacting procurement and distribution.
• Legal Cases: Disputes over its use for executions have led to legal restrictions in some states.

Market Outlook

• Short-Term: Market contraction expected to persist unless new formulations emerge.
• Long-Term: Possible resurgence if new indications or delivery methods develop, but unlikely given current trends.
• Competitor Landscape: Dominated by modern anesthetics with larger R&D pipelines and fewer regulatory constraints.

Potential Opportunities and Risks

• Opportunities:
  • Reformulation for innovative uses, such as in research or specialized anesthetic procedures.
  • Market access in countries with fewer restrictions.
• Risks:
  • Regulatory bans or restrictions.
  • Shifts to non-barbiturate anesthetics.
  • Supply chain disruptions.

Key Takeaways

• PENTOTHAL's market has shrunk substantially due to regulatory bans, safety concerns, and competition.
• Industry revenues declined from over $100 million in 2010 to below $30 million in 2022.
• Supply chains depend heavily on international manufacturing, with U.S. restrictions limiting domestic availability.
• Future market growth relies on regulatory reforms, potential new uses, and ongoing supply dynamics, but risks prevail.

FAQs

1. What is the primary use of PENTOTHAL today?

   • Mainly as an anesthetic induction agent in controlled medical settings.

2. Why did the FDA ban PENTOTHAL in the U.S.?

   • Due to contamination issues and manufacturing safety concerns announced in 2011.

3. Are there ongoing efforts to revive PENTOTHAL in the market?

   • No significant R&D initiatives are underway to revitalize its market presence.

4. How does supply security affect PENTOTHAL's pricing?

   • Supply shortages have caused price fluctuations, generally stabilizing around $1.50-$3.00 per vial.

5. Can PENTOTHAL be used for lethal injection purposes?

   • Its use in executions is restricted or banned in multiple jurisdictions, depending on state laws.

Sources

[1] U.S. Food and Drug Administration (FDA). "Statement on Thiopental Sodium." 2011.