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Last Updated: March 19, 2026

thiamylal sodium - Profile


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

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

Summary for thiamylal sodium
US Patents:0
Tradenames:1
Applicants:1
NDAs:1

US Patents and Regulatory Information for thiamylal sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parkedale SURITAL thiamylal sodium INJECTABLE;INJECTION 007600-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Parkedale SURITAL thiamylal sodium INJECTABLE;INJECTION 007600-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Parkedale SURITAL thiamylal sodium INJECTABLE;INJECTION 007600-009 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Thiamylal sodium Market Analysis and Financial Projection

Last updated: February 9, 2026

What Is the Investment Scenario for Thiamylal Sodium?

Thiamylal sodium is a barbiturate used primarily as an anesthetic or sedative. Its pharmaceutical market is limited and specialized, with production controlled by a small number of manufacturers. The compound’s regulatory status, production costs, and clinical utility influence its investment appeal.

Market presence is predominantly in regions where barbiturates retain medical use, notably some Asian countries and specific niches in Europe and the United States. The global market for anesthetic agents is trending toward newer agents with better safety profiles. This dynamic constrains the growth potential for traditional barbiturates like thiamylal sodium.

Forecast growth for thiamylal sodium remains modest. Factors restraining investment include declining demand in Western markets driven by regulatory restrictions and the adoption of non-barbiturate anesthetics. Some emerging markets maintain demand due to lower cost and existing manufacturing infrastructure.

Key valuation points:

  • Market size estimated at less than $50 million worldwide.
  • Limited pipeline activity, with no major pharmaceutical companies actively developing derivatives or new formulations.
  • Market decline expected over next five years, with some stabilization in specific regional markets.

What Are the Fundamentals for Thiamylal Sodium?

Production and Supply Chain

Manufactured through complex synthesis involving multiple steps, with key raw materials often sourced from specialized chemical suppliers. Since it is a controlled substance, production is subject to strict regulatory oversight, including licensing and periodic audits. This increases operational costs and limits alternative sourcing options.

Regulatory Environment

Thiamylal sodium is regulated as a controlled substance in many jurisdictions, classified as a Schedule III or equivalent drug due to its potential for dependency. Regulatory authorities such as the U.S. FDA, EMA, and comparable agencies in Asia restrict approval to specific clinical uses, often limiting commercialization.

Recent regulatory trends show increased scrutiny of barbiturates due to safety concerns, pushing companies to reconsider investments centered on these compounds. Nonetheless, some countries permit its use for anesthesia, maintaining niche markets.

Patents and Intellectual Property

Thiamylal sodium’s composition patents have largely expired, reducing barriers to generic manufacturing. This has resulted in price compression and reduced margins. No current patents protect new formulations or indications.

Clinical and Commercial Utility

Clinically, thiamylal sodium offers rapid induction of anesthesia and short duration, which suits certain surgical settings. Its safety profile includes risks like respiratory depression and hypotension, which have led to decreased preference in favor of newer agents such as propofol.

Commercial utility is constrained further by the availability of alternative anesthetics with better safety and side effect profiles. The drug's use is mainly limited to specific regions with longstanding familiarity and supply chains.

Competitive Landscape

The market for intravenous anesthetic agents is dominated by non-barbiturates like propofol, ketamine, and etomidate. Thiamylal sodium faces competition solely in niche markets, with No major breakthroughs or novel derivatives in development.

Financial Metrics

Estimated manufacturing costs range between $0.50 to $1.00 per dose. Selling prices vary regionally but typically hover around $5 to $15 per dose, depending on purity, formulation, and regulatory permissions.

Profit margins are low for producers, compounded by regulatory compliance costs. The price pressures from generics further diminish long-term profitability prospects.

What Are the Investment Risks and Opportunities?

Risks:

  • Regulatory restrictions and potential bans in key markets.
  • Competitive displacement by newer, safer anesthetics.
  • Market decline driven by shifting clinical preferences.
  • Limited pipeline and innovation pipeline.

Opportunities:

  • Niche applications in regions with persistent demand.
  • Potential conversion to alternative formulations or delivery methods.
  • Generic manufacturing cost advantages.
  • Use in specific medical settings where alternatives are unavailable or unsuitable.

Key Takeaways

  • The global market for thiamylal sodium is below $50 million, with flat or declining growth prospects.
  • Demand persists mainly in specific Asian markets and niche clinical settings.
  • Regulatory requirements and safety concerns limit wider adoption.
  • Price competition from generics compresses margins.
  • Innovation activity is minimal, highlighting limited long-term growth potential.

FAQs

  1. Is there any ongoing R&D to improve thiamylal sodium?
    No significant R&D projects are publicly known. Most activity centers around generic manufacturing and quality control.

  2. Can regulatory changes revive demand?
    Possible, but unlikely in major markets, where safety-related restrictions are increasing. Regional variations might offer temporary opportunities.

  3. What alternative drugs are replacing thiamylal sodium?
    Propofol, etomidate, and ketamine dominate the intravenous anesthetic market due to better safety profiles.

  4. What regions hold the most promise for investment?
    Certain Asian countries with ongoing requirements for older anesthetic agents may sustain limited demand.

  5. How does patent expiration affect the market?
    Patent expiration has allowed generic manufacturing, leading to pricing pressures and reduced margins for producers.


References

[1] IMS Health. "Global Anesthetic Market Analysis," 2022.

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