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Last Updated: December 26, 2024

SODIUM BUTABARBITAL Drug Patent Profile


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US Patents and Regulatory Information for SODIUM BUTABARBITAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma SODIUM BUTABARBITAL butabarbital sodium TABLET;ORAL 085418-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lannett SODIUM BUTABARBITAL butabarbital sodium TABLET;ORAL 085881-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ivax Sub Teva Pharms SODIUM BUTABARBITAL butabarbital sodium TABLET;ORAL 084040-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Marshall Pharma SODIUM BUTABARBITAL butabarbital sodium TABLET;ORAL 083524-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma SODIUM BUTABARBITAL butabarbital sodium TABLET;ORAL 085432-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

SODIUM BUTABARBITAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sodium Butabarbital

Introduction

Sodium butabarbital, commonly known as Butabarbital or Butisol, is a barbiturate with a fast onset and short duration of action. This drug has been used for treating severe insomnia, pre-operative anxiety, and other conditions requiring sedation. Here, we will delve into the market dynamics and financial trajectory of sodium butabarbital.

Historical Context of Barbiturates

Historically, barbiturates, including sodium butabarbital, were widely prescribed in the mid-20th century. By the 1960s, the production and sale of barbituric acid derivatives were significant, with over 700,000 pounds produced annually in the United States alone. This period saw a high demand for sedatives and tranquillizers, with barbiturates ranking among the most frequently prescribed drugs[1].

Current Market Size and Forecast

The barbiturate drug market, which includes sodium butabarbital, is expected to grow at a moderate pace. As of 2024, the global barbiturate drug market is valued at approximately USD 492.8 million. This market is forecast to expand at a Compound Annual Growth Rate (CAGR) of 3.20% from 2024 to 2034, reaching a valuation of USD 675 million by 2034[4].

Regional Market Dynamics

United States

The United States leads the barbiturate drug market and is expected to continue its dominance. By 2034, the U.S. market is projected to attain a valuation of USD 120.1 million, growing at a CAGR of 3.5% over the forecast period. Key factors driving this growth include the ongoing use of barbiturates in certain neurological disorders and the presence of established pharmaceutical companies[4].

United Kingdom

In the UK, the consumption of barbiturates is expected to increase at a CAGR of 4.40% over the next decade. By 2034, the demand is anticipated to reach a valuation of USD 27.5 million, driven by similar factors as in the U.S., including the treatment of specific patient demographics and neurological conditions[4].

China, Japan, and South Korea

In China, the barbiturate drug market is projected to reach USD 106.8 million by 2034, growing at a CAGR of 3.9%. Japan's market is expected to register a remuneration of USD 75 million by 2034, with a CAGR of 4.9%. South Korea’s market is forecast to expand at a CAGR of 5.3%, reaching USD 43.8 million by 2034. These regions are driven by increasing healthcare needs and the expansion of the pharmaceutical sector[4].

Factors Influencing Market Growth

Rising Demand for Long-Acting Barbiturates

Despite the rise of benzodiazepines, there is still a significant demand for long-acting barbiturates, particularly in the treatment of epilepsy and other neurological disorders. This demand is a key driver of the market growth[4].

Emerging Opportunities for Novel Barbiturate-Based Analgesics

Research advancements and innovations in barbiturate discovery are opening up new opportunities for the development of novel barbiturate-based analgesics. This trend is expected to contribute to the market's expansion[4].

Competition from Benzodiazepines

However, the market growth is somewhat hindered by the increasing use of benzodiazepines for sedative and hypnotic purposes. Benzodiazepines have become preferred alternatives in many clinical settings due to their perceived safety and efficacy profiles[4].

Pharmacological and Clinical Use

Mechanism of Action

Sodium butabarbital works by potentiating GABAergic neurons and inhibiting neuronal acetylcholine and glutamate receptors, leading to sedation. Its intermediate duration of action, approximately 6-8 hours, makes it useful for specific clinical applications[5].

Clinical Applications

Butabarbital is used for treating severe insomnia and pre-operative anxiety. It is also employed in the management of certain neurological conditions. However, its use has declined in recent years as benzodiazepines have become more popular[2][3].

Abuse Potential and Safety Concerns

Butabarbital has a high abuse potential due to its short duration of action, comparable to secobarbital. This has led to strict regulatory oversight and caution in its prescription. Patients must be counselled about the risks of worsening insomnia, drowsiness, falls, and complex behaviors while not fully awake[2][5].

Elimination and Metabolism

Butabarbital is predominantly eliminated in the urine, with a small percentage excreted unchanged. The plasma half-life of butabarbital is approximately 100 hours, although its duration of action is much shorter, typically 6-8 hours[3][5].

Pricing and Cost

The cost of butabarbital sodium tablets varies, with prices ranging from approximately $1.89 for a 30 mg tablet to $2.46 for a 50 mg tablet. These prices are indicative and can vary based on market conditions and geographical location[5].

Key Takeaways

  • The global barbiturate drug market, including sodium butabarbital, is expected to grow at a CAGR of 3.20% from 2024 to 2034.
  • Regional markets such as the U.S., UK, China, Japan, and South Korea are driving this growth.
  • The market is influenced by the rising demand for long-acting barbiturates and emerging opportunities for novel barbiturate-based analgesics.
  • Despite competition from benzodiazepines, sodium butabarbital remains a significant player in the treatment of specific neurological and sleep disorders.
  • The drug's high abuse potential and safety concerns necessitate careful prescription and patient counselling.

FAQs

What is the primary use of sodium butabarbital?

Sodium butabarbital is primarily used for treating severe insomnia and pre-operative anxiety. It is also employed in the management of certain neurological conditions.

How does sodium butabarbital work?

Sodium butabarbital works by potentiating GABAergic neurons and inhibiting neuronal acetylcholine and glutamate receptors, leading to sedation.

What is the abuse potential of sodium butabarbital?

Sodium butabarbital has a high abuse potential due to its short duration of action, comparable to secobarbital.

What are the key factors driving the growth of the barbiturate drug market?

The growth is driven by the rising demand for long-acting barbiturates, emerging opportunities for novel barbiturate-based analgesics, and the ongoing use in certain neurological disorders.

How is sodium butabarbital eliminated from the body?

Sodium butabarbital is predominantly eliminated in the urine, with a small percentage excreted unchanged.

Sources

  1. UNODC - Bulletin on Narcotics - 1964 Issue 1: "Production and Sale of Barbituric Acid."
  2. DrugBank Online: "Butabarbital sodium."
  3. Pharmacompass: "Butabarbital | Drug Information, Uses, Side Effects, Chemistry."
  4. Future Market Insights: "Barbiturate Drug Market Share, Trends & Forecast 2034."
  5. DrugBank: "Butabarbital: Uses, Interactions, Mechanism of Action."

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