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Last Updated: March 17, 2025

Mebutamate - Generic Drug Details


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

Mebutamate is the generic ingredient in one branded drug marketed by Medpointe Pharm Hlc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for mebutamate
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 34
Patent Applications: 986
DailyMed Link:mebutamate at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for mebutamate

US Patents and Regulatory Information for mebutamate

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Medpointe Pharm Hlc DORMATE mebutamate TABLET;ORAL 017374-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Meprobamate

Introduction

Meprobamate, a drug marketed as a sedative, anxiolytic agent, or muscle relaxant, has a complex market dynamic due to its potential for abuse and dependency. Here, we will delve into the market dynamics and financial aspects of meprobamate, highlighting key factors that influence its market position and financial performance.

Product Overview

Meprobamate is known for its sedative and anxiolytic properties but also carries significant risks, including CNS depression and the potential for abuse, especially when combined with other central nervous system depressants[4].

Regulatory Environment

In the United States, meprobamate is listed as a Schedule IV drug under the Controlled Substances Act, indicating it has a lower potential for abuse compared to Schedule I, II, or III substances but still requires careful regulation. This classification affects its market dynamics, as it is subject to stricter prescribing and dispensing guidelines[4].

Market Competition

The market for sedatives and anxiolytics is highly competitive, with numerous drugs available. Meprobamate competes with other benzodiazepines and non-benzodiazepines that offer similar therapeutic benefits but may have different side effect profiles or abuse potentials. The competitive landscape is further complicated by the presence of generic versions of these drugs, which can significantly impact the market share and revenue of branded products.

Promotion and Advertising

In markets with high competition, promotional expenditures play a crucial role. Studies have shown that in pharmaceutical markets, especially those with differentiated products, promotional spending can be substantial. For example, in the market for oral diuretics and antianginal drugs, non-leading firms often spend more on promotion relative to their sales compared to leading firms, highlighting the intense competition and the need to differentiate products through aggressive marketing[1].

Financial Performance

The financial performance of meprobamate is influenced by several factors, including prescription rates, competition from other sedatives, regulatory changes, and public health trends. Here are some key financial aspects:

Revenue Trends

Revenue from meprobamate can fluctuate based on prescribing patterns and competition. For instance, if there is a shift towards newer, safer anxiolytics or sedatives, the revenue from meprobamate could decline. Conversely, if there is an increase in demand for sedatives due to public health issues such as anxiety disorders, revenue could increase.

Cost Structure

The cost structure for meprobamate includes research and development (R&D) expenses, manufacturing costs, and significant selling, general, and administrative (SG&A) expenses due to the need for robust marketing and regulatory compliance. Companies like Shionogi, which invest heavily in R&D, may see fluctuations in their financial performance based on the success of their drug portfolios, including those related to sedatives and anxiolytics[3].

Impact of Regulatory Changes

Regulatory changes can significantly impact the financial trajectory of meprobamate. For example, if stricter prescribing guidelines are implemented due to concerns over abuse, this could lead to a decrease in prescriptions and subsequently in revenue.

Public Health Trends

Public health trends, such as the COVID-19 pandemic, can also influence the market dynamics of meprobamate. During the pandemic, there was an increase in anxiety and stress-related disorders, which could have led to an increase in prescriptions for anxiolytics like meprobamate. However, this trend may be temporary and subject to change as public health measures evolve[3].

Consumer Preferences and Physician Behavior

Consumer preferences and physician behavior play a crucial role in the market dynamics of meprobamate. Physicians often prefer established brands with known therapeutic profiles, which can make it challenging for new entrants or less popular drugs like meprobamate to gain market share. Additionally, consumer awareness about the potential for abuse can affect demand[1].

Illustrative Statistics

To understand the financial trajectory better, let's consider some illustrative statistics:

  • Revenue Impact: A company like Shionogi might see a significant impact on its revenue from changes in the market for sedatives and anxiolytics. For instance, a 25.5% increase in OTC and quasi-drug revenue due to strong sales of infectious disease-related products can highlight the volatility in pharmaceutical markets[3].

  • R&D Expenses: Increased R&D expenses, such as those related to COVID-19, can affect the overall financial performance. For example, a 12.6% increase in R&D expenses can be a significant factor in the financial trajectory of a pharmaceutical company[3].

Key Takeaways

  • Regulatory Environment: Meprobamate's classification as a Schedule IV drug affects its market dynamics and financial performance.
  • Market Competition: The competitive landscape for sedatives and anxiolytics is intense, with significant promotional expenditures.
  • Financial Performance: Revenue trends, cost structure, and regulatory changes are critical factors in the financial trajectory of meprobamate.
  • Public Health Trends: Public health issues like the COVID-19 pandemic can temporarily influence demand for anxiolytics.
  • Consumer Preferences and Physician Behavior: Established brands and consumer awareness about abuse potential are key determinants of market share.

FAQs

Q: What is meprobamate used for? A: Meprobamate is used as a sedative, anxiolytic agent, or muscle relaxant.

Q: Why is meprobamate regulated? A: Meprobamate is regulated due to its potential for abuse and dependency, and it is listed as a Schedule IV drug under the Controlled Substances Act.

Q: How does competition affect the market for meprobamate? A: The market for sedatives and anxiolytics is highly competitive, with numerous drugs available, which affects the market share and revenue of meprobamate.

Q: What are the financial implications of regulatory changes on meprobamate? A: Regulatory changes, such as stricter prescribing guidelines, can lead to a decrease in prescriptions and revenue for meprobamate.

Q: How do public health trends impact the demand for meprobamate? A: Public health trends, such as the COVID-19 pandemic, can temporarily increase demand for anxiolytics like meprobamate due to increased anxiety and stress-related disorders.

Sources

  1. Federal Trade Commission. Sales, Promotion, and Product Differentiation in Two Prescription Drug Markets. 1977.
  2. Meng Fanwang. Overcoming the Curse of Missing and Noisy Data in Computational Chemistry. McMaster University, 2021.
  3. Shionogi Inc. Q3 Financial Results Briefing for the Fiscal Year Ending March 2021. 2021.
  4. Randox Toxicology. Meprobamate. Retrieved from https://www.randoxtoxicology.com/meprobamate/

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