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Last Updated: January 5, 2025

Methyprylon - Generic Drug Details


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

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

Summary for methyprylon
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 15
Patent Applications: 2,524
DailyMed Link:methyprylon at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for methyprylon

US Patents and Regulatory Information for methyprylon

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche NOLUDAR methyprylon CAPSULE;ORAL 009660-008 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Roche NOLUDAR methyprylon TABLET;ORAL 009660-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Roche NOLUDAR methyprylon ELIXIR;ORAL 009660-007 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Roche NOLUDAR methyprylon TABLET;ORAL 009660-002 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

Methyprylon Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Methyprylon

Introduction

Methyprylon, a sedative of the piperidinedione derivative family, was once widely used for treating insomnia. However, its market presence and financial trajectory have been significantly impacted by various factors, including the introduction of newer drugs, adverse effects, and regulatory actions.

Historical Context

Methyprylon was first developed by Hoffmann-La Roche and introduced to the market as a non-barbiturate sedative-hypnotic. It was marketed under several trade names, including Dimerin, Methyprylone, Noctan, and Noludar[1][4].

Market Withdrawal

One of the most significant events in the market dynamics of methyprylon was its withdrawal from major markets. It was withdrawn from the U.S. market in June 1975 and from the Canadian market in September 1990 due to adverse events and the availability of safer alternatives[1][4].

Replacement by Newer Drugs

The introduction of benzodiazepines and other newer sedatives with fewer side effects significantly reduced the demand for methyprylon. Benzodiazepines offered better safety profiles and more effective treatment options for insomnia and anxiety, leading to a decline in the use of methyprylon[1][4].

Adverse Effects and Safety Concerns

Methyprylon was associated with a range of adverse effects, including skin rash, fever, depression, ulcers or sores in the mouth or throat, unusual bleeding or bruising, confusion, fast heartbeat, respiratory depression, and others. These safety concerns further diminished its market viability[1][4].

Pharmacokinetics and Metabolism

The pharmacokinetics of methyprylon, including its half-life of 6-16 hours and 60% protein binding, did not significantly contribute to its market appeal. In overdose cases, the pharmacokinetics were found to be non-concentration dependent, which complicated the management of overdoses[1][4].

Economic Implications

The economic implications of methyprylon's market withdrawal are multifaceted. The drug's removal from the market resulted in significant financial losses for the manufacturers and distributors. Additionally, the shift towards newer, safer drugs required substantial investment in research and development, further impacting the financial trajectory of companies involved in sedative-hypnotic drug development[3].

Impact on Pharmaceutical Industry

The case of methyprylon highlights the challenges and risks associated with drug development and market dynamics. The increasing focus on precision medicines and drugs targeting small patient populations, as seen in other pharmaceutical sectors, underscores the need for careful market analysis and risk assessment. For instance, drugs like Kalydeco, which target very small patient populations, can have high prices but limited competition due to the small market size[3].

Regulatory Environment

Regulatory actions played a crucial role in the market dynamics of methyprylon. The drug's withdrawal was a direct result of regulatory decisions based on safety concerns. This emphasizes the importance of a favorable regulatory environment for drug development and market success. Strong, consistent regulatory policies can influence investor confidence and the overall financial health of pharmaceutical companies[1][4].

Consumer Preferences and Market Trends

Consumer preferences for safer and more effective treatments have driven the market away from methyprylon. The trend towards using drugs with better safety profiles and fewer side effects is a key factor in the financial trajectory of pharmaceutical companies. Companies that adapt to these trends by investing in R&D for safer drugs are more likely to succeed in the market[1][4].

Financial Trajectory

The financial trajectory of methyprylon is characterized by a decline in sales and eventual market withdrawal. The costs associated with its development, marketing, and subsequent withdrawal would have been significant. The financial impact on the companies involved would have included losses from discontinued sales, potential legal liabilities, and the costs of transitioning to newer products.

Key Financial Metrics

  • Revenue Decline: The revenue from methyprylon would have declined sharply following the introduction of safer alternatives and regulatory actions.
  • R&D Costs: Significant investments in R&D would have been required to develop and market methyprylon, which were ultimately not recovered due to its market withdrawal.
  • Legal and Regulatory Costs: Costs associated with regulatory compliance, legal challenges, and potential lawsuits related to adverse effects would have added to the financial burden.

Conclusion

The market dynamics and financial trajectory of methyprylon are a cautionary tale for pharmaceutical companies. The drug's history highlights the importance of safety, regulatory compliance, and adapting to market trends. As the pharmaceutical industry continues to evolve, understanding these factors is crucial for developing successful and financially viable drugs.

Key Takeaways

  • Methyprylon was withdrawn from major markets due to adverse effects and the availability of safer alternatives.
  • The introduction of benzodiazepines significantly reduced the demand for methyprylon.
  • Regulatory actions and safety concerns played a critical role in its market withdrawal.
  • The financial trajectory of methyprylon was marked by a decline in sales and significant financial losses.
  • Adapting to market trends and investing in R&D for safer drugs is essential for pharmaceutical companies.

FAQs

What was methyprylon used for?

Methyprylon was used for the treatment of insomnia and daytime tension.

Why was methyprylon withdrawn from the market?

Methyprylon was withdrawn from the U.S. and Canadian markets due to adverse events and the availability of safer alternatives like benzodiazepines.

What are some of the adverse effects associated with methyprylon?

Adverse effects include skin rash, fever, depression, ulcers or sores in the mouth or throat, unusual bleeding or bruising, confusion, fast heartbeat, and respiratory depression.

How does the pharmacokinetics of methyprylon affect its use?

The pharmacokinetics of methyprylon, including its half-life and protein binding, did not significantly contribute to its market appeal. In overdose cases, the pharmacokinetics were found to be non-concentration dependent.

What is the current status of methyprylon in the pharmaceutical market?

Methyprylon is no longer used clinically and has been replaced by newer drugs with fewer side effects. It is considered a withdrawn drug in major markets.

Sources

  1. Wikipedia: Methyprylon
  2. Calgary Economic Development: Alberta Energy Transition Report
  3. National Bureau of Economic Research: The Economics of Drug Development: Pricing and Innovation
  4. DrugBank: Methyprylon
  5. NPS History: Wildlife Immobilization

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