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Last Updated: January 8, 2025

Ethotoin - Generic Drug Details


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

Ethotoin is the generic ingredient in one branded drug marketed by Recordati Rare 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 ethotoin.

Summary for ethotoin
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 44
Clinical Trials: 1
Patent Applications: 3,909
What excipients (inactive ingredients) are in ethotoin?ethotoin excipients list
DailyMed Link:ethotoin at DailyMed
Recent Clinical Trials for ethotoin

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

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

See all ethotoin clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ethotoin

US Patents and Regulatory Information for ethotoin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Recordati Rare PEGANONE ethotoin TABLET;ORAL 010841-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Recordati Rare PEGANONE ethotoin TABLET;ORAL 010841-001 Approved Prior to Jan 1, 1982 DISCN Yes 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

Ethotoin Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Ethotoin

Introduction

Ethotoin, a hydantoin derivative and anticonvulsant, is used to control tonic-clonic and complex partial seizures. Here, we delve into the market dynamics and financial trajectory of this drug, exploring its current market status, growth prospects, and the factors influencing its market performance.

Market Size and Growth

The hydantoin anticonvulsants market, which includes Ethotoin, was valued at USD 208.058 million in 2021 and is projected to reach USD 280.39 million by 2029, growing at a Compound Annual Growth Rate (CAGR) of 3.80% during the forecast period of 2022-2029[1].

Market Segmentation

The hydantoin anticonvulsants market is segmented based on several factors, including the type of drug, application, dosage, route of administration, end-users, and distribution channels. Ethotoin falls under the category of hydantoin derivatives, which are used primarily for treating epilepsy and related seizure disorders.

Applications of Ethotoin

Ethotoin is specifically used to control tonic-clonic and complex partial seizures. Its antiepileptic effect is achieved without causing general central nervous system depression, making it a valuable option in the treatment of epilepsy[4].

Mechanism of Action

The mechanism of action of Ethotoin is similar to that of Phenytoin, another hydantoin derivative. It stabilizes the normal seizure threshold and prevents the spread of seizure activity rather than abolishing the primary focus of seizure discharges. Ethotoin inhibits nerve impulses in the motor cortex by lowering sodium ion influx, limiting tetanic stimulation[4].

Regional Analysis

The hydantoin anticonvulsants market is dominated by North America due to the rising prevalence of epilepsy in this region and the presence of well-established healthcare infrastructure. Asia-Pacific is also expected to grow significantly during the forecast period, driven by increasing healthcare expenditure and improvements in healthcare infrastructure[1].

Drivers of Market Growth

Several factors are driving the growth of the hydantoin anticonvulsants market, including:

  • Increasing Approval of Anticonvulsant Medicines: The US Food and Drug Administration (FDA) has approved approximately 24 anticonvulsant medicines, including those derived from marijuana for treating rare forms of epilepsy. This increasing approval rate is boosting the market's growth[1].
  • Rising Research and Development Activities: Increased R&D activities are providing beneficial opportunities for the hydantoin anticonvulsants market. New drug launches and advancements in technology are further propelling market growth[1].
  • Public and Private Initiatives: Rising initiatives by public and private organizations to spread awareness about epilepsy and its treatments are expanding the market[1].
  • Healthcare Expenditure and Lifestyle Changes: Increasing healthcare expenditure and changing lifestyles are contributing to the market's expansion[1].

Restraints and Challenges

Despite the growth prospects, the market faces several challenges:

  • High Development and Distribution Costs: The high costs associated with drug development and distribution are significant restraints. These costs can be prohibitive, especially for smaller pharmaceutical companies[1].
  • Side Effects: Ethotoin, like other hydantoin anticonvulsants, has side effects such as dizziness, irritability, drowsiness, fatigue, headache, and vertigo, which can impede market growth[1].
  • Lack of Skilled Professionals and Healthcare Infrastructure: In developing economies, the lack of skilled professionals and adequate healthcare infrastructure poses a significant challenge to the market[1].

Financial Trajectory

The financial trajectory of Ethotoin, as part of the hydantoin anticonvulsants market, is influenced by several financial metrics:

  • Revenue Growth: The market is expected to grow from USD 208.058 million in 2021 to USD 280.39 million by 2029, indicating a steady revenue growth trajectory[1].
  • Generic Competition: The entry of generic competitors can significantly impact the pricing and profitability of Ethotoin. Generic prices decline with the number of producers, approaching long-run marginal costs when there are 8 or more competitors[3].
  • Reimbursement Policies: Favourable reimbursement policies can enhance the market's growth rate by making the drug more accessible to patients[1].

Key Takeaways

  • The hydantoin anticonvulsants market, including Ethotoin, is expected to grow at a CAGR of 3.80% from 2022 to 2029.
  • The market is driven by increasing FDA approvals, R&D activities, public awareness initiatives, and rising healthcare expenditure.
  • Challenges include high development costs, side effects, and lack of skilled professionals and healthcare infrastructure in developing economies.
  • Generic competition and reimbursement policies play crucial roles in shaping the financial trajectory of Ethotoin.

FAQs

Q: What is the primary use of Ethotoin? A: Ethotoin is primarily used to control tonic-clonic and complex partial seizures.

Q: How does Ethotoin exert its antiepileptic effect? A: Ethotoin stabilizes the normal seizure threshold and prevents the spread of seizure activity by inhibiting nerve impulses in the motor cortex through the reduction of sodium ion influx[4].

Q: What are the major drivers of the hydantoin anticonvulsants market? A: The market is driven by increasing FDA approvals, rising R&D activities, public awareness initiatives, and increasing healthcare expenditure[1].

Q: What are the significant challenges facing the hydantoin anticonvulsants market? A: High development and distribution costs, side effects of the drugs, and lack of skilled professionals and healthcare infrastructure in developing economies are significant challenges[1].

Q: How does generic competition affect the pricing of Ethotoin? A: Generic competition leads to a decline in prices as the number of producers increases, with prices approaching long-run marginal costs when there are 8 or more competitors[3].

Sources

  1. Data Bridge Market Research: Global Hydantoin Anticonvulsants Market Size & Growth Analysis By 2029.
  2. International League Against Epilepsy: The second period: 1953.
  3. Federal Trade Commission: Generic Drug Industry Dynamics.
  4. DrugBank Online: Ethotoin: Uses, Interactions, Mechanism of Action.

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