You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

CHLORMEZANONE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for chlormezanone and what is the scope of freedom to operate?

Chlormezanone is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for chlormezanone.

Summary for CHLORMEZANONE
Recent Clinical Trials for CHLORMEZANONE

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

SponsorPhase
Canadian Institutes of Health Research (CIHR)
Canadian Network for Observational Drug Effect Studies, CNODES
Drug Safety and Effectiveness Network, Canada

See all CHLORMEZANONE clinical trials

Medical Subject Heading (MeSH) Categories for CHLORMEZANONE

US Patents and Regulatory Information for CHLORMEZANONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us TRANCOPAL chlormezanone TABLET;ORAL 011467-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us TRANCOPAL chlormezanone TABLET;ORAL 011467-005 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

CHLORMEZANONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Chlormezanone

Introduction

Chlormezanone, a non-benzodiazepine muscle relaxant and anxiolytic, was once a significant player in the pharmaceutical market. However, its market dynamics and financial trajectory have been significantly impacted by several key factors.

Historical Context

Chlormezanone was used in the management of anxiety and the treatment of muscle spasm. It was introduced as a safer alternative to benzodiazepines due to its non-benzodiazepine structure, but it ultimately faced severe challenges[1].

Discontinuation and Market Impact

The most critical event in the market dynamics of chlormezanone was its discontinuation worldwide in 1996. This decision was made by the manufacturer due to confirmed serious and rare cutaneous reactions, including toxic epidermal necrolysis. This severe adverse effect profile led to a complete withdrawal from the market, effectively ending its commercial viability[1].

Financial Consequences

The financial trajectory of chlormezanone was severely impacted by its discontinuation. Prior to its withdrawal, the drug generated revenue through its use in anxiety and muscle spasm management. However, once it was taken off the market, all revenue streams ceased. This abrupt end to its commercial life meant that any investments in the drug's development, marketing, and distribution were rendered futile.

Regulatory and Safety Concerns

Regulatory bodies play a crucial role in the market dynamics of pharmaceuticals. The serious adverse effects associated with chlormezanone led to strict regulatory actions, culminating in its global withdrawal. This highlights the importance of safety in drug development and the significant financial risks associated with drugs that fail to meet safety standards[1].

Alternative Market Options

Following the discontinuation of chlormezanone, the market shifted towards other safer alternatives for anxiety and muscle spasm treatment. This shift included the increased use of other non-benzodiazepine anxiolytics and muscle relaxants that had better safety profiles. The market adapted quickly, minimizing the financial impact on the broader pharmaceutical sector but significantly affecting the specific financial trajectory of chlormezanone.

Lessons Learned

The case of chlormezanone serves as a cautionary tale for pharmaceutical companies. It underscores the importance of rigorous safety testing and the potential financial consequences of failing to meet safety standards. Companies must invest heavily in clinical trials and post-marketing surveillance to mitigate such risks.

Current Market Landscape

Today, the market for muscle relaxants and anxiolytics is dominated by drugs with proven safety profiles. The global market for therapeutic drugs continues to grow, but it is driven by innovative and safe treatments. For instance, the global market for antibody drugs, which are often used in treating chronic conditions, is expected to grow significantly, but this growth is not related to chlormezanone[3].

Financial Trajectory Summary

  • Introduction and Initial Success: Chlormezanone was introduced as a promising non-benzodiazepine muscle relaxant and anxiolytic.
  • Discontinuation: Withdrawn from the market in 1996 due to serious adverse effects.
  • Financial Consequences: Immediate cessation of revenue streams.
  • Regulatory Impact: Highlighted the importance of safety in drug development.
  • Market Adaptation: Shift to safer alternatives minimized broader market impact.

Key Takeaways

  • Chlormezanone's market dynamics were severely impacted by its discontinuation due to safety concerns.
  • The financial trajectory ended abruptly with the drug's withdrawal from the market.
  • The incident emphasizes the critical importance of safety in pharmaceutical development.
  • The market has adapted to safer alternatives, ensuring continued growth in the sector.

Frequently Asked Questions (FAQs)

Q: Why was chlormezanone discontinued? A: Chlormezanone was discontinued worldwide in 1996 due to confirmed serious and rare cutaneous reactions, including toxic epidermal necrolysis[1].

Q: What were the financial consequences of chlormezanone's discontinuation? A: The discontinuation led to an immediate cessation of all revenue streams associated with the drug.

Q: How did the market adapt to the discontinuation of chlormezanone? A: The market shifted towards other safer alternatives for anxiety and muscle spasm treatment, minimizing the broader financial impact on the pharmaceutical sector.

Q: What lessons can be learned from the case of chlormezanone? A: The case highlights the importance of rigorous safety testing and the potential financial consequences of failing to meet safety standards.

Q: Is chlormezanone still used in any medical contexts? A: No, chlormezanone is no longer used in any medical contexts due to its global withdrawal from the market.

Cited Sources:

  1. DrugBank: Chlormezanone: Uses, Interactions, Mechanism of Action.
  2. PharmaCompass: Various pharmaceutical industry reports and updates.
  3. BCC Research: Antibody Drugs: Technologies and Global Markets.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.