Thiopental sodium - Generic Drug Details

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

Thiopental sodium is the generic ingredient in one branded drug marketed by Abbott and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for thiopental sodium.

Summary for thiopental sodium

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	14
DailyMed Link:	thiopental sodium at DailyMed

Recent Clinical Trials for thiopental sodium

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

Sponsor	Phase
Ain Shams University	Early Phase 1
Ain Shams University	N/A
Konkuk University Medical Center	N/A

See all thiopental sodium clinical trials

Medical Subject Heading (MeSH) Categories for thiopental sodium

Anesthetics, Intravenous

Anticonvulsants

GABA Modulators

Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for thiopental sodium

N01AF	Barbiturates, plain
N01A	ANESTHETICS, GENERAL
N01	ANESTHETICS
N	Nervous system

N05CA	Barbiturates, plain
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for thiopental sodium

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

Thiopental sodium Market Analysis and Financial Projection

Last updated: February 14, 2026

What Are the Market Dynamics for Thiopental Sodium?

Thiopental sodium, also known as sodium pentothal, is a barbiturate historically utilized as an anesthetic induction agent and in some procedures requiring rapid unconsciousness. The drug's use has significantly declined in recent years due to ethical concerns, regulatory restrictions, and the development of newer anesthetics.

Market Trends:

• The global anesthetics market is projected to grow modestly, reaching approximately $15 billion by 2027, with barbiturates like thiopental sodium accounting for a decreasing share (1).
• Demand is primarily from regions with legacy use in certain surgical procedures and medical research, mainly in developing economies.
• Ethical concerns and legal restrictions minimize the drug's availability in several jurisdictions, notably in the U.S. and Europe, where it is classified as a controlled substance.
• Several manufacturers have ceased production, leading to supply constraints. Suppliers remaining in the market face increased regulation, impacting pricing and availability.
• Alternative anesthetic agents, including propofol and etomidate, overshadow thiopental in clinical settings, further shrinking its market presence.

Regulatory Environment:

• In the U.S., thiopental sodium is classified under Schedule III or Class 2 substances, requiring strict control and limiting civilian access.
• Several countries have banned or restricted its use solely to veterinary applications or research purposes.

Competitive Landscape:

• Few manufacturers produce thiopental sodium; key players include Hospira (now part of Pfizer), and some generic pharmaceutical companies.
• Market penetration is declining as newer agents replace thiopental for induction anesthesia.

Supply Chain Factors:

• Production complexities and regulatory compliance have reduced the number of suppliers, risking supply shortages.
• Existing stocks are often outdated or phased out, impacting clinical availability.

What Is the Financial Trajectory of Thiopental Sodium?

The financial outlook is bleak due to declining demand and tightening regulations.

Revenue Trends:

• Drops in global sales, estimated to have peaked in the early 2000s and now approaching negligible levels in developed markets.
• For example, Pfizer reported minimal revenue from thiopental sodium in recent fiscal years, with potential discontinuation of manufacturing (2).

Pricing Dynamics:

• Prices have remained stable or increased modestly due to supply scarcity; however, actual transactions are uncommon.
• Treatment of existing inventory often involves salvage or repurposing, not new sales.

Cost Structure:

• Manufacturing costs remain high due to strict regulations and low economies of scale.
• R&D expenditures on thiopental are negligible; focus shifts towards new anesthetic compounds.

Investment and R&D Outlook:

• Little to no investment is allocated for the development or marketing of thiopental sodium.
• Industry focus has shifted toward agents with improved safety profiles and regulatory approvals.

Market Exit Risks:

• Several suppliers are likely to withdraw, further diminishing the drug's commercial viability.
• Legal restrictions will continue to limit market access, especially in healthcare systems with strict controlled substance policies.

Key Takeaways

• The global market for thiopental sodium has contracted sharply, driven by regulatory restrictions, ethical debates, and competition from newer anesthetics.
• Current demand is mostly in niche or legacy sectors; widespread clinical use has largely ceased.
• Few manufacturers remain in the market, and supply shortages are increasingly common.
• Revenue prospects are near zero in mature markets; sporadic sales occur in emerging economies.
• Future financial trajectory indicates continued decline, with potential phase-out by major pharmaceutical companies.

FAQs

1. Is thiopental sodium still available for clinical use?
   Its availability is limited to certain jurisdictions and research purposes. Most clinical applications in developed countries have shifted to alternative anesthetics.

2. What are the main legal restrictions impacting thiopental sodium?
   It is classified as a controlled substance, with regulations varying by country, often requiring special licenses for possession and use.

3. Are there any ongoing R&D efforts for thiopental sodium?
   No significant R&D investments are noted; the focus in anesthetic development targets newer, safer agents.

4. Which regions still host demand for thiopental sodium?
   Demand persists mainly in some developing countries and research settings, but overall consumption is minimal.

5. What is the outlook for suppliers currently producing thiopental sodium?
   They face declining revenues, increased regulatory burdens, and potential market exits, risking supply disruptions.

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Sources

1. MarketWatch. "Global Anesthetics Market Forecast." 2022.
2. Pfizer Earnings Reports. 2021-2023.