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Last Updated: December 22, 2024

Ethinamate - Generic Drug Details


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

Ethinamate is the generic ingredient in one branded drug marketed by Dista 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 ethinamate.

Summary for ethinamate

US Patents and Regulatory Information for ethinamate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dista VALMID ethinamate CAPSULE;ORAL 009750-001 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

Ethinamate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ethinamate

Introduction

Ethinamate, known by the brand names Valamin and Valmid, is a short-acting carbamate-derivative sedative-hypnotic medication primarily used to treat insomnia. Here, we will delve into the market dynamics and financial trajectory of ethinamate, highlighting its current status, historical use, and the factors influencing its market presence.

Historical Use and Replacement

Ethinamate was once a commonly prescribed medication for insomnia but has largely been replaced by other classes of drugs, particularly benzodiazepines. This shift is due to several factors, including the development of more effective and safer alternatives, as well as the inherent limitations and risks associated with ethinamate itself[1][4].

Market Availability

Ethinamate is no longer available in several major markets, including the Netherlands, the United States, and Canada. This limited availability significantly impacts its market dynamics and financial performance, as it restricts the drug's potential for sales and revenue generation[1].

Regulatory Status

In the United States, ethinamate is classified as a Schedule IV substance, indicating it has a lower potential for abuse compared to Schedule III substances but still carries risks of dependence. This regulatory status further influences its market and financial trajectory by imposing strict controls on its distribution and use[1].

Dependence and Tolerance

One of the critical factors affecting the market for ethinamate is its potential for tolerance and dependence. Regular use of ethinamate leads to drug tolerance, making it ineffective for more than 7 days. Prolonged use can result in physical dependence, with withdrawal symptoms similar to those of barbiturates. This has led healthcare providers to seek alternative treatments, reducing the demand for ethinamate[1][4].

Pharmacokinetics and Metabolism

Ethinamate is rapidly absorbed from the gastrointestinal tract and metabolized by the liver, with its major metabolite being hydroxyethinamate. This pharmacokinetic profile, while important for understanding the drug's action, does not significantly impact its market dynamics but is crucial for clinical use and safety considerations[4].

Financial Performance

Given the replacement of ethinamate by other medications and its limited market availability, the financial performance of ethinamate is not robust. The drug's sales have declined significantly over the years, and it no longer contributes substantially to the pharmaceutical market revenue.

Market Trends in Sedative-Hypnotics

The market for sedative-hypnotic medications has evolved, with a shift towards safer and more effective drugs. The global market for breakthrough therapies, which includes newer sedatives and hypnotics, is expected to grow significantly, with a CAGR of 13.8% from 2024 to 2029. However, ethinamate does not benefit from this growth due to its outdated status and replacement by newer drugs[3].

Competitive Landscape

The competitive landscape in the sedative-hypnotic market is dominated by benzodiazepines and other newer classes of drugs. These alternatives offer better efficacy and safety profiles, further marginalizing ethinamate in the market. Major pharmaceutical companies are focusing on developing and marketing these newer drugs, which has led to a decline in the commercial viability of ethinamate[1][4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceuticals. For ethinamate, strict regulations and the classification as a Schedule IV substance in the U.S. limit its market potential. The expedited approval processes for newer breakthrough therapies in regions like Europe also contribute to the diminished role of ethinamate in the market[3].

Conclusion

Ethinamate, once used to treat insomnia, has seen a significant decline in its market presence due to several factors, including the development of safer and more effective alternatives, its potential for tolerance and dependence, and limited market availability. The financial trajectory of ethinamate reflects this decline, with the drug no longer contributing substantially to pharmaceutical market revenue.

Key Takeaways

  • Ethinamate has been largely replaced by other sedative-hypnotic medications.
  • It is not available in several major markets, including the U.S., Canada, and the Netherlands.
  • The drug has a high potential for tolerance and dependence.
  • Ethinamate is classified as a Schedule IV substance in the U.S.
  • The market for sedative-hypnotics is dominated by newer, safer drugs.

FAQs

What is ethinamate used for?

Ethinamate is used to treat insomnia, although it has been largely replaced by other medications.

Why has ethinamate been replaced by other drugs?

Ethinamate has been replaced due to its potential for tolerance and dependence, as well as the availability of safer and more effective alternatives like benzodiazepines.

Is ethinamate available in the U.S.?

No, ethinamate is not available in the United States.

What are the side effects of ethinamate?

Regular use of ethinamate can lead to drug tolerance and physical dependence, with withdrawal symptoms similar to those of barbiturates.

How is ethinamate metabolized?

Ethinamate is rapidly absorbed from the gastrointestinal tract and metabolized by the liver, with its major metabolite being hydroxyethinamate.

Sources

  1. Wikipedia - Ethinamate
  2. Pharmacompass - Bayer Pharma AG
  3. BCC Research - Global Breakthrough Therapies Market Size and Growth Forecast
  4. Pharmacompass - Ethinamate | Drug Information, Uses, Side Effects, Chemistry

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