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Last Updated: December 23, 2024

HALOTHANE - Generic Drug Details


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

Halothane is the generic ingredient in two branded drugs marketed by Wyeth Ayerst, BH, Halocarbon, and Hospira, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for halothane.

Summary for HALOTHANE
Recent Clinical Trials for HALOTHANE

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

SponsorPhase
Cairo UniversityPhase 1/Phase 2
University Hospital OlomoucPhase 2
The Institute of Molecular and Translational Medicine, Czech RepublicPhase 2

See all HALOTHANE clinical trials

Medical Subject Heading (MeSH) Categories for HALOTHANE
Anatomical Therapeutic Chemical (ATC) Classes for HALOTHANE

US Patents and Regulatory Information for HALOTHANE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bh HALOTHANE halothane LIQUID;INHALATION 084977-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Halocarbon HALOTHANE halothane LIQUID;INHALATION 080810-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wyeth Ayerst FLUOTHANE halothane LIQUID;INHALATION 011338-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira HALOTHANE halothane LIQUID;INHALATION 083254-001 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

HALOTHANE Market Analysis and Financial Projection Experimental

Halothane: Market Dynamics and Financial Trajectory

Introduction

Halothane, a potent inhalation anesthetic, has been a significant player in the medical field since its introduction in the 1950s. However, its market dynamics and financial trajectory have undergone substantial changes over the years due to various factors including safety concerns, environmental impact, and the emergence of newer anesthetic agents.

Historical Context

Halothane was first synthesized in 1951 and approved for medical use in the United States in 1958. It quickly gained popularity due to its nonflammable nature and effectiveness as a general anesthetic, replacing earlier volatile anesthetics like trichloroethylene, diethyl ether, and cyclopropane[4].

Market Size and Growth

In the past, halothane was a major contributor to the inhalation anesthetics market. However, its market share has significantly declined over the years.

  • Peak Usage: During its peak in the 1960s and 1970s, halothane was widely used in both developed and developing countries. It was particularly favored for its ease of use in pediatric anesthesia due to its lack of airway irritation[4].

  • Decline: By the 1980s, concerns over its safety, particularly regarding hepatotoxicity and cardiac arrhythmias, led to a dramatic reduction in its use. Newer anesthetic agents like isoflurane, sevoflurane, and desflurane replaced halothane in many clinical settings[4].

Current Market Status

As of today, halothane is no longer commercially available in the United States and has been largely replaced by newer anesthetic agents in developed countries.

  • Regional Usage: Despite its decline in developed countries, halothane is still used in some developing countries due to its lower cost. However, this usage is also diminishing as these countries adopt newer, safer anesthetics[4].

Financial Trajectory

The financial trajectory of halothane reflects its declining market presence.

  • Revenue Decline: The revenue generated from halothane sales has significantly decreased over the years. This decline is part of the broader trend where the global inhalation anesthetics market is shifting towards newer, more advanced drugs. For instance, the global inhalation anesthetics market, which includes newer agents like sevoflurane and desflurane, is expected to grow from USD 1.78 billion in 2022 to USD 2.76 billion by 2030, at a CAGR of 5.66%[1].

  • Market Share: Halothane's market share has dwindled to a negligible fraction of the total inhalation anesthetics market. The North American region, which was once a significant market for halothane, now dominates the market with newer anesthetics, holding a 39.55% market revenue share in 2022[1].

Drivers and Restraints

Several factors have influenced the market dynamics of halothane:

Drivers

  • Cost: In developing countries, the lower cost of halothane has kept it in use, albeit to a lesser extent[4].

Restraints

  • Safety Concerns: The primary restraint has been the safety profile of halothane. Its association with hepatotoxicity, cardiac arrhythmias, and malignant hyperthermia has led to its widespread replacement by safer alternatives[4].
  • Environmental Impact: Halothane is a greenhouse gas and contributes to ozone depletion, although its impact is less significant compared to other chlorofluorocarbons due to its short atmospheric lifetime. However, this environmental concern has further diminished its appeal[2][4].

Opportunities and Challenges

Opportunities

  • Emerging Markets: While halothane's use is declining globally, there might still be opportunities in very resource-constrained settings where newer anesthetics are not readily available or affordable.

Challenges

  • Regulatory Environment: Stringent regulations and guidelines governing the use of anesthetic agents pose a significant challenge. The preference for safer, more environmentally friendly alternatives is heavily influenced by regulatory bodies and clinical guidelines[1].
  • Competition from Newer Agents: The market is dominated by newer anesthetic agents like sevoflurane, isoflurane, and desflurane, which offer better safety profiles and fewer environmental concerns[1].

Key Takeaways

  • Halothane's market presence has significantly declined due to safety concerns and the emergence of newer anesthetic agents.
  • The drug is no longer commercially available in the United States and is being phased out in other developed countries.
  • Its use is limited to some developing countries where cost is a significant factor.
  • The global inhalation anesthetics market is growing, but halothane is not a part of this growth trajectory.

FAQs

  1. Why has the use of halothane declined?

    • The use of halothane has declined primarily due to safety concerns, including its association with hepatotoxicity, cardiac arrhythmias, and malignant hyperthermia.
  2. Is halothane still used in any regions?

    • Yes, halothane is still used in some developing countries where its lower cost makes it more accessible.
  3. What are the environmental impacts of halothane?

    • Halothane is a greenhouse gas and contributes to ozone depletion, although its impact is less significant compared to other chlorofluorocarbons due to its short atmospheric lifetime.
  4. Which anesthetic agents have replaced halothane?

    • Newer anesthetic agents like sevoflurane, isoflurane, and desflurane have largely replaced halothane in clinical settings.
  5. Is halothane commercially available in the United States?

    • No, halothane is no longer commercially available in the United States.

Sources

  1. The Brainy Insights - Inhalation Anesthetics Market Dynamics, Industry Report 2030
  2. Journal of Anesthesiology and Perioperative Medicine - Atmospheric records of halogenated anesthetics
  3. Future Market Insights - General Anesthesia Drugs Market Size, Trends - 2033
  4. Wikipedia - Halothane

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