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Last Updated: December 22, 2024

METOPIRONE Drug Patent Profile


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When do Metopirone patents expire, and what generic alternatives are available?

Metopirone is a drug marketed by Hra Pharma and is included in one NDA.

The generic ingredient in METOPIRONE is metyrapone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the metyrapone profile page.

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Summary for METOPIRONE
Drug patent expirations by year for METOPIRONE
Drug Prices for METOPIRONE

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Recent Clinical Trials for METOPIRONE

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

SponsorPhase
Foundation for a Smoke-Free WorldPhase 1/Phase 2
Embera NeuroTherapeutics, Inc.Phase 1/Phase 2
Rose Research Center, LLCPhase 1/Phase 2

See all METOPIRONE clinical trials

Pharmacology for METOPIRONE

US Patents and Regulatory Information for METOPIRONE

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

METOPIRONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Metopirone

Introduction to Metopirone

Metopirone, also known as metyrapone, is a medication primarily used for the diagnosis of adrenal insufficiency and in the management of Cushing's syndrome. It works by inhibiting the 11-beta-hydroxylation reaction in the adrenal cortex, reducing cortisol and corticosterone production[2][4].

Market Size and Growth

The market for Cushing's syndrome therapies, which includes Metopirone, was valued at approximately $121.4 million in 2020. This market is expected to grow at a Compound Annual Growth Rate (CAGR) of more than 10% from 2020 to 2030[1].

Key Market Drivers

Launch of New Treatments

The introduction of new treatments such as Recorlev, Relacorilant, and SPI-62 is expected to drive the growth of the Cushing's syndrome market. These novel therapies offer more efficacious options for patients, potentially increasing market size and shifting market share away from traditional treatments like ketoconazole and metyrapone[1].

Expanding Access to Novel Therapies

The increasing access to novel steroidogenesis inhibitors, such as Isturisa, particularly in the EU and Germany, will also contribute to market growth. Isturisa is expected to erode the market share of less effective traditional therapies, including Metopirone[1].

Market Statistics

  • 2020 Market Value: $121.4 million
  • CAGR: More than 10% from 2020 to 2030
  • Forecast Period: 2021-2030
  • Key Markets: US and Germany dominate the market[1].

Competitive Landscape

Key Drugs

Metopirone competes with other key drugs in the Cushing's syndrome market, including Signifor/Signifor LAR, Korlym, Isturisa, Metopirone, Lysodren, and Ketoconazole (both branded and generic)[1].

Key Therapies

The market includes various therapies such as steroidogenesis inhibitors, GR-II antagonists, and SPI-62. Metopirone falls under the category of steroidogenesis inhibitors[1].

Companies Involved

Companies like Corcept Therapeutics Inc., Recordati SpA, Laboratorie HRA Pharma SAS, Strongbridge Biopharma PLC, and Sparrow Pharmaceuticals are significant players in this market[1].

Regulatory and Development Challenges

Stringent Regulatory Environments

The adrenal corticosteroid inhibitors market, which includes Metopirone, faces challenges due to stringent regulatory environments. These regulations can slow down the approval process for new drugs and impact market growth[3].

High Costs of Drug Development

The high costs associated with drug development and the potential side effects of these medications can also hinder market expansion. These factors can affect patient compliance and overall market dynamics[3].

Financial Trajectory

Current and Projected Market Value

While the specific financial trajectory for Metopirone alone is not detailed, the overall market for Cushing's syndrome therapies is expected to grow significantly. The broader adrenal corticosteroid inhibitors market, valued at $2.49 billion in 2023, is projected to reach $5.78 billion by 2030, growing at a CAGR of 12.75%[3].

Revenue Impact of New Treatments

The introduction of new treatments will likely impact the revenue share of traditional drugs like Metopirone. As more efficacious therapies become available, the market share of older drugs may decline, affecting their financial performance.

Clinical and Diagnostic Use

Diagnostic Indications

Metopirone is used in combination with other diagnostic tests for the diagnosis of adrenal insufficiency in adult and pediatric patients. Its pharmacological effect involves reducing cortisol and corticosterone production, which helps in assessing pituitary ACTH responsiveness[2][4].

Pharmacodynamics and Pharmacokinetics

The drug inhibits the 11-beta-hydroxylation reaction, leading to an increase in ACTH production and a corresponding elevation of steroid precursors in the plasma and urine. This mechanism is crucial for its diagnostic use[2][4].

Side Effects and Contraindications

Adverse Reactions

Metopirone can cause various side effects, including hypotension, nausea, vomiting, abdominal discomfort, headache, dizziness, sedation, and allergic rash. It is contraindicated in patients with adrenal insufficiency and requires cautious use in elderly patients due to potential decreased hepatic, renal, or cardiac function[2][4].

Future Outlook

Innovations and Personalized Medicine

The future of the adrenal corticosteroid inhibitors market, including Metopirone, lies in innovations such as personalized medicine and genetic insights. Companies that invest in cutting-edge research and patient-centric solutions are likely to achieve a competitive advantage[3].

Regulatory Adaptation

Adapting promptly to regulatory changes and navigating through the challenges of drug development will be crucial for companies to capture opportunities in this market.

"Innovating in personalized medicine, leveraging genetic insights to tailor inhibitor profiles, and enhancing collaboration between biotech and pharmaceutical companies can foster significant business growth"[3].

Key Takeaways

  • The Cushing's syndrome market, which includes Metopirone, is expected to grow at a CAGR of more than 10% from 2020 to 2030.
  • New treatments like Recorlev, Relacorilant, and SPI-62 will drive market growth.
  • Metopirone competes with other key drugs and therapies in the market.
  • Regulatory challenges and high development costs are significant barriers.
  • The broader adrenal corticosteroid inhibitors market is projected to reach $5.78 billion by 2030.

FAQs

What is the primary use of Metopirone?

Metopirone is primarily used for the diagnosis of adrenal insufficiency and in the management of Cushing's syndrome.

What is the expected growth rate of the Cushing's syndrome market?

The Cushing's syndrome market is expected to grow at a CAGR of more than 10% from 2020 to 2030.

What are the key challenges facing the adrenal corticosteroid inhibitors market?

The market faces challenges due to stringent regulatory environments, high costs of drug development, and potential side effects.

How does Metopirone work pharmacologically?

Metopirone inhibits the 11-beta-hydroxylation reaction in the adrenal cortex, reducing cortisol and corticosterone production and increasing ACTH production.

What are the potential side effects of Metopirone?

Metopirone can cause side effects such as hypotension, nausea, vomiting, abdominal discomfort, headache, dizziness, sedation, and allergic rash.

Sources

  1. GlobalData, "Cushing's Syndrome - Opportunity Assessment and Forecast to 2030"
  2. FDA, "Metopirone (metyrapone) capsules label"
  3. 360iResearch, "Adrenal Corticosteroid Inhibitors Market by Drug, Treatment Type"
  4. Drugs.com, "Metopirone: Package Insert / Prescribing Information"

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