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Last Updated: December 22, 2024

Metyrapone - Generic Drug Details


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

Metyrapone is the generic ingredient in one branded drug marketed by Hra Pharma 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 metyrapone. One supplier is listed for this compound.

Summary for metyrapone
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 109
Clinical Trials: 21
Patent Applications: 2,413
What excipients (inactive ingredients) are in metyrapone?metyrapone excipients list
DailyMed Link:metyrapone at DailyMed
Recent Clinical Trials for metyrapone

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

SponsorPhase
Mayo ClinicPhase 2
Maria Sklodowska-Curie National Research Institute of OncologyPhase 2
Biostat Sp. z o.o.Phase 2

See all metyrapone clinical trials

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

US Patents and Regulatory Information for metyrapone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hra Pharma METOPIRONE metyrapone CAPSULE;ORAL 012911-002 Aug 9, 1996 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hra Pharma METOPIRONE metyrapone TABLET;ORAL 012911-001 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

Metyrapone Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Metyrapone

Introduction

Metyrapone is a small molecule drug that has been a cornerstone in the treatment of various endocrine and metabolic disorders for several decades. Here, we delve into the market dynamics and financial trajectory of metyrapone, exploring its current status, future prospects, and the factors influencing its market performance.

Historical Context and Approval

Metyrapone was first approved for use in the United States in December 1961. It is primarily used in the treatment of conditions such as hyperaldosteronism, adrenal insufficiency, Cushing syndrome, and as a diagnostic agent for assessing the functioning of the hypothalamic-pituitary-adrenal (HPA) axis[4].

Market Size and Share

The global market for adrenal corticosteroid inhibitors, which includes metyrapone, is characterized by a niche but significant presence. While specific financial figures for metyrapone alone are not readily available, the broader market context provides valuable insights. The adrenal corticosteroid inhibitors market is expected to grow, driven by increasing demand for treatments of rare endocrine disorders[1].

Key Indications and Usage

Metyrapone targets the enzyme CYP11B1, crucial in cortisol synthesis. Its primary indications include:

  • Hyperaldosteronism: Reducing aldosterone levels to manage symptoms.
  • Adrenal Insufficiency: Stimulating cortisol production to restore hormonal balance.
  • Cushing Syndrome: Inhibiting cortisol synthesis to manage symptoms.
  • Diagnostic Agent: Assessing HPA axis function[4].

Market Drivers

Several factors drive the market for metyrapone:

  • Increasing Incidence of Endocrine Disorders: The rising prevalence of conditions like Cushing syndrome and adrenal insufficiency contributes to the demand for metyrapone.
  • Orphan Drug Status: Metyrapone's classification as an orphan drug provides regulatory benefits and incentives, encouraging its development and commercialization[4].
  • Lack of Alternative Treatments: For certain rare conditions, metyrapone remains one of the few effective treatment options, ensuring a steady demand.

Market Restraints

Despite its importance, the market for metyrapone faces several challenges:

  • Limited Indications: Metyrapone's use is confined to a few specific conditions, limiting its market expansion.
  • Side Effects and Tolerability: The drug is associated with significant side effects, such as adrenal insufficiency, which can impact patient compliance and acceptance[5].

Competitive Landscape

The competitive landscape for metyrapone involves several key players:

  • Novartis SA: As the originator and primary developer of metyrapone, Novartis plays a significant role in its market presence.
  • Other Competitors: Other pharmaceutical companies are also developing drugs targeting the CYP11B1 enzyme, indicating a competitive market environment[4].

Regional Analysis

The market for metyrapone is not evenly distributed globally:

  • North America and Europe: These regions are significant markets due to higher awareness and diagnosis rates of endocrine disorders.
  • Emerging Markets: Countries like Japan and China are also showing growth potential, driven by increasing healthcare spending and awareness[3][4].

Financial Trajectory

While specific financial data for metyrapone is not available, the broader market trends provide insights:

  • Revenue Growth: The adrenal corticosteroid inhibitors market, which includes metyrapone, is expected to grow over the forecast period, driven by increasing demand and limited alternative treatments.
  • CAGR: The market is anticipated to grow at a moderate CAGR, reflecting the steady but not explosive growth in this niche segment[1].

Research and Development

Continuous research and development are crucial for the market trajectory of metyrapone:

  • Clinical Trials: Ongoing clinical trials and studies aim to expand the indications for metyrapone and improve its efficacy and safety profile.
  • Combination Therapies: Exploring combination therapies with other drugs could enhance treatment efficacy and open up new market opportunities[4].

Regulatory Environment

The regulatory environment plays a critical role in the market dynamics of metyrapone:

  • Orphan Drug Benefits: Metyrapone's orphan drug status provides regulatory incentives, such as extended market exclusivity and reduced regulatory fees.
  • Approval Processes: Streamlined approval processes for rare disease treatments support the market growth of metyrapone[4].

Consumer Behavior and Compliance

Patient compliance and behavior significantly impact the market:

  • Side Effects Management: Effective management of side effects is crucial for maintaining patient compliance.
  • Education and Awareness: Increasing awareness among healthcare providers and patients about the benefits and risks of metyrapone can improve its market performance[5].

Technological Trends

Advancements in technology and drug development are shaping the future of metyrapone:

  • Small Molecule Drugs: The development of small molecule drugs targeting CYP11B1 is a key area of innovation.
  • Diagnostic Radiopharmaceuticals: Advances in diagnostic agents are enhancing the ability to assess HPA axis function, supporting the use of metyrapone[4].

Market Attractiveness

The market attractiveness for metyrapone is influenced by several factors:

  • Unmet Needs: The lack of effective treatments for certain endocrine disorders makes metyrapone an attractive option.
  • Competitive Landscape: The presence of multiple companies developing drugs targeting CYP11B1 indicates a competitive but potentially lucrative market[4].

SWOT Analysis

Strengths

  • Established Efficacy: Metyrapone has a long history of efficacy in treating specific endocrine disorders.
  • Orphan Drug Status: Regulatory benefits associated with its orphan drug status.

Weaknesses

  • Limited Indications: Confined to a few specific conditions.
  • Side Effects: Significant side effects can impact patient compliance.

Opportunities

  • Combination Therapies: Exploring combination therapies to enhance treatment efficacy.
  • New Indications: Potential expansion into new indications.

Threats

  • Competitive Landscape: Increasing competition from other drugs targeting CYP11B1.
  • Regulatory Changes: Changes in regulatory environments could impact market exclusivity and incentives[4].

Key Takeaways

  • Metyrapone is a critical drug in the treatment of rare endocrine disorders.
  • Its market is driven by increasing demand, orphan drug status, and limited alternative treatments.
  • The drug faces challenges such as limited indications and significant side effects.
  • Continuous R&D and regulatory support are essential for its market growth.

FAQs

What is the primary mechanism of action of metyrapone?

Metyrapone targets the enzyme CYP11B1, which is crucial in cortisol synthesis, thereby modulating cortisol production[4].

What are the main indications for metyrapone?

Metyrapone is primarily used in the treatment of hyperaldosteronism, adrenal insufficiency, Cushing syndrome, and as a diagnostic agent for assessing HPA axis function[4].

What are the major market drivers for metyrapone?

The market is driven by the increasing incidence of endocrine disorders, its orphan drug status, and the lack of alternative treatments[4].

What are the significant side effects associated with metyrapone?

Adrenal insufficiency is one of the notable side effects associated with metyrapone, which can impact patient compliance and acceptance[5].

Which region is expected to dominate the market for metyrapone?

North America and Europe are significant markets due to higher awareness and diagnosis rates of endocrine disorders, with emerging markets like Japan and China also showing growth potential[3][4].

Sources

  1. Cognitivemarketresearch.com: Adrenal Corticosteroid Inhibitors Market Report 2024 (Global Edition)
  2. Frontiersin.org: Methamphetamine and the hypothalamic-pituitary-adrenal axis
  3. Credenceresearch.com: Mitotane Drug Market By Size, Share, Revenue and Trends 2030
  4. Synapse.patsnap.com: An In-depth Analysis of Metyrapone's R&D Progress and Mechanism of Action
  5. Accessdata.fda.gov: Center for Drug Evaluation and Research - Osilodrostat NDA 212801Orig1s000SumR.pdf

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