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Last Updated: December 23, 2024

Ethchlorvynol - Generic Drug Details


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

Ethchlorvynol is the generic ingredient in two branded drugs marketed by Banner Pharmacaps and Abbvie, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for ethchlorvynol.

Summary for ethchlorvynol
Recent Clinical Trials for ethchlorvynol

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

SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all ethchlorvynol clinical trials

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

US Patents and Regulatory Information for ethchlorvynol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie PLACIDYL ethchlorvynol CAPSULE;ORAL 010021-007 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Banner Pharmacaps ETHCHLORVYNOL ethchlorvynol CAPSULE;ORAL 084463-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Banner Pharmacaps ETHCHLORVYNOL ethchlorvynol CAPSULE;ORAL 084463-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Banner Pharmacaps ETHCHLORVYNOL ethchlorvynol CAPSULE;ORAL 084463-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbvie PLACIDYL ethchlorvynol CAPSULE;ORAL 010021-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbvie PLACIDYL ethchlorvynol CAPSULE;ORAL 010021-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbvie PLACIDYL ethchlorvynol CAPSULE;ORAL 010021-010 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

Ethchlorvynol Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ethchlorvynol

Introduction

Ethchlorvynol, known by its brand name Placidyl®, is a tertiary acetylenic alcohol used as an oral hypnotic and sedative agent. To understand its market dynamics and financial trajectory, it is crucial to delve into various aspects including its usage, regulatory environment, competition, and economic factors.

Regulatory Environment

Ethchlorvynol is classified as a Schedule IV controlled substance, indicating it has a lower potential for abuse compared to Schedule III substances but can still lead to physical or psychological dependence. This classification affects its market dynamics, as it is subject to stricter regulations and monitoring[4].

Market Demand and Usage

Ethchlorvynol is used to manage insomnia and other sleep disorders. The demand for such medications is influenced by the prevalence of sleep disorders and the availability of alternative treatments. Given its specific use case, the market demand is relatively niche compared to broader pharmaceutical markets.

Competition in the Sedative Market

The sedative and hypnotic market is competitive, with several other drugs available, such as benzodiazepines and non-benzodiazepine hypnotics. The entry of generic competitors can significantly impact the market share and pricing of branded drugs like ethchlorvynol. Generic drug prices tend to fall with the number of competitors, but they remain above long-run marginal costs until there are 8 or more competitors[5].

Pricing and Profitability

The pricing of ethchlorvynol is influenced by its classification as a controlled substance and the presence of generic competitors. Branded drugs typically enjoy higher price-cost margins until generic versions enter the market. For ethchlorvynol, the transition to generic status would likely reduce its market price, affecting its profitability.

Impact of Generic Competition

Generic competition plays a crucial role in the financial trajectory of ethchlorvynol. As more generic firms enter the market, prices decline, and profits are competed away. Studies have shown that generic drug prices begin to approach long-run marginal costs when there are 8 or more competitors, significantly reducing the profitability of the original branded drug[5].

Economic Ramifications of Development and Innovation

The development and innovation in the pharmaceutical industry, particularly in the area of sedatives and hypnotics, can affect the market dynamics of ethchlorvynol. Advances in precision medicines and targeted therapies might shift market focus away from traditional sedatives, impacting demand and pricing. However, the fixed costs of research and development for new drugs, especially those targeting small patient populations, can justify higher prices for drugs like ethchlorvynol that provide significant value to a specific group of patients[3].

Financial Performance Over Time

The financial performance of ethchlorvynol would typically follow a pattern seen in many pharmaceutical products:

  • Launch Phase: High profitability due to patent protection and lack of competition.
  • Generic Entry: Significant decline in prices and profitability as generic versions enter the market.
  • Maturity Phase: Stabilization of prices at a lower level, with reduced market share and profitability.

Example of Market Dynamics

For instance, when a drug like ethchlorvynol loses its patent protection, the market dynamics change dramatically. The entry of generic competitors can reduce the market share of the branded version by up to 90% within a few months. This transition is accompanied by a substantial drop in prices, making the drug more affordable but less profitable for the original manufacturer[5].

Market Concentration and Entry Barriers

The market for sedatives and hypnotics has specific entry barriers, including regulatory hurdles and the need for significant investment in research and development. These barriers limit the number of new entrants, allowing existing players to maintain a level of market concentration. However, once a generic version of ethchlorvynol is approved, the market becomes more competitive, and the concentration of market share among a few players decreases[5].

Consumer and Prescriber Behavior

Consumer and prescriber behavior also influence the market dynamics of ethchlorvynol. Prescribers may prefer newer, safer alternatives, and consumers may opt for over-the-counter sleep aids, affecting the demand for prescription sedatives like ethchlorvynol.

Key Takeaways

  • Regulatory Impact: Ethchlorvynol's classification as a Schedule IV controlled substance affects its market dynamics and pricing.
  • Generic Competition: The entry of generic competitors significantly reduces the market price and profitability of ethchlorvynol.
  • Economic Ramifications: Advances in pharmaceutical innovation and the focus on precision medicines can impact demand and pricing.
  • Financial Performance: The financial trajectory of ethchlorvynol follows a typical pattern of high profitability during the launch phase, followed by a decline with generic entry, and stabilization at lower prices in the maturity phase.

FAQs

What is ethchlorvynol used for?

Ethchlorvynol is used as an oral hypnotic and sedative agent to manage insomnia and other sleep disorders.

How does the regulatory environment affect ethchlorvynol?

As a Schedule IV controlled substance, ethchlorvynol is subject to stricter regulations and monitoring, which can impact its market dynamics and pricing.

What happens to the market price of ethchlorvynol when generic versions enter the market?

The market price of ethchlorvynol significantly declines as generic competitors enter the market, with prices approaching long-run marginal costs when there are 8 or more competitors.

How do advances in pharmaceutical innovation impact ethchlorvynol?

Advances in precision medicines and targeted therapies can shift market focus away from traditional sedatives like ethchlorvynol, affecting demand and pricing.

What is the typical financial trajectory for a drug like ethchlorvynol?

The financial trajectory typically includes high profitability during the launch phase, a significant decline with generic entry, and stabilization at lower prices in the maturity phase.

Sources

  1. Taylor & Francis - Ethchlorvynol – Knowledge and References
  2. Federal Trade Commission - Generic Drug Industry Dynamics
  3. National Bureau of Economic Research - The Economics of Drug Development: Pricing and Innovation in a Changing Market
  4. Taylor & Francis - Ethchlorvynol – Knowledge and References
  5. Federal Trade Commission - Generic Drug Industry Dynamics

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