BUTABARBITAL Drug Patent Profile

When do Butabarbital patents expire, and when can generic versions of Butabarbital launch?

Butabarbital is a drug marketed by Bundy, Wockhardt, Sandoz, Solvay, Teva, Watson Labs, and Whiteworth Town Plsn. and is included in sixteen NDAs.

The generic ingredient in BUTABARBITAL is butabarbital sodium. There are nine drug master file entries for this compound. Additional details are available on the butabarbital sodium profile page.

Summary for BUTABARBITAL

US Patents:	0
Applicants:	7
NDAs:	16

US Patents and Regulatory Information for BUTABARBITAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bundy	BUTABARBITAL	butabarbital sodium	TABLET;ORAL	085550-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Solvay	BUTABARBITAL SODIUM	butabarbital sodium	TABLET;ORAL	083606-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sandoz	BUTABARBITAL SODIUM	butabarbital sodium	TABLET;ORAL	085938-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Teva	BUTABARBITAL SODIUM	butabarbital sodium	TABLET;ORAL	088631-001	May 1, 1985		DISCN	No	No
Solvay	BUTABARBITAL SODIUM	butabarbital sodium	TABLET;ORAL	083898-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Investment and Fundamentals Analysis of Butabarbital

Last updated: February 22, 2026

What is Butabarbital?

Butabarbital is a short- to intermediate-acting barbiturate, classified as a Schedule III controlled substance in the United States. It is used primarily for short-term treatment of insomnia and relief of anxiety. It acts centrally as a depressant, enhancing GABA activity in the brain.

Market Overview and Regulatory Status

Butabarbital has experienced declining use due to safety concerns and the availability of safer alternatives, including benzodiazepines and non-benzodiazepine sleep aids. It remains on the market primarily for niche applications.

• Market size: The global hypnotic and sedative market was valued at approximately USD 3.5 billion in 2021, with barbiturates representing a small fraction (<5%), mostly for specialized medical use.
• Regulatory environment: It is regulated under the Controlled Substances Act (CSA) in the U.S. (Schedule III since 1970) and similar regulations worldwide. Strict scheduling limits manufacturing, distribution, and prescribing.

Patent and Commercial Landscape

• Patent status: No recent patent protections exist for Butabarbital, as it was developed in the early 20th century.
• Generic availability: Multiple manufacturers produce generic formulations, resulting in limited pricing power.
• Market exclusivity: None, due to the age of the compound and patent expiry.

Pharmacological and Safety Profile

• Efficacy: Effective as a short-term sedative but overshadowed by benzodiazepines.
• Safety concerns: Risks include dependence, overdose, respiratory depression, and withdrawal syndrome.
• Side effects: Drowsiness, dizziness, allergic reactions, and cognitive impairment.

Competitive Analysis

Aspect	Butabarbital	Benzodiazepines (e.g., Diazepam)	Non-Benzodiazepines (e.g., Zolpidem)
Safety profile	Higher risk of dependence and overdose	Lower risk, but same concerns exist	Safer, fewer dependencies reported
Market presence	Niche	Dominant in sleep treatment	Growing segment
Regulatory restrictions	Strict	Similar	Similar

R&D and Development Potential

• No recent advanced formulations or indications under development.
• Potential for reformulation or combination with new delivery methods, but regulatory hurdles are significant given safety profiles.

Investment Risks and Considerations

• Market decline: The use of barbiturates has sharply declined over decades.
• Regulatory challenges: Future restrictions could further limit market access.
• Liability risk: Due to safety profile, lawsuits related to overdose or dependence may increase.
• Replacement by safer drugs: The shift toward benzodiazepines and non-benzodiazepine treatment reduces demand.

Key Takeaways

• Butabarbital has minimal future growth potential given the current market's preference for safer alternatives.
• Its patent expiry and generic status result in limited profit margins.
• Regulatory environment and safety concerns intensify investment risks.
• Market share is expected to continue declining, confined mainly to legacy or niche applications.
• Potential niche interests could include reformulation or combination therapies, but these face high regulatory barriers.

FAQs

1. Why is Butabarbital no longer widely used?
It is replaced by benzodiazepines and non-benzodiazepines, which have safer profiles and fewer dependency risks.

2. Are there any new formulations or patents for Butabarbital?
No. The compound has been off patent for decades, and no significant R&D efforts have been announced.

3. Can Butabarbital be part of future drug combination therapies?
Potentially, but regulatory approval would require demonstrating safety and efficacy enhancements, which is unlikely given its risk profile.

4. What are the main regulatory hurdles for Butabarbital?
Strict scheduling limits manufacturing, prescribing, and distribution, complicating market expansion or R&D.

5. Is there any ongoing legal risk associated with Butabarbital?
Legal risks stem from its safety profile, including dependence and overdose concerns, which could lead to litigation.

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References

[1] U.S. Food and Drug Administration. (2021). Controlled Substance Schedules.
[2] MarketWatch. (2022). Global Hypnotics and Sedatives Market Analysis.
[3] DEA Diversion Control Division. (2022). Schedule III Substances.
[4] WHO. (2020). Essential Medicines List: Barbiturates.