METYRAPONE - Generic Drug Details

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

Metyrapone is the generic ingredient in one branded drug marketed by Esteve 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. Two suppliers are 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:	2
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	27
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

Sponsor	Phase
Mayo Clinic	PHASE2
Laik General Hospital, Athens	PHASE4
University of Calgary	PHASE2

See all METYRAPONE clinical trials

Pharmacology for METYRAPONE

Drug Class	Adrenal Steroid Synthesis Inhibitor
Mechanism of Action	Adrenal Steroid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for METYRAPONE

Antimetabolites

Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for METYRAPONE

V04CD	Tests for pituitary function
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

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
Esteve	METOPIRONE	metyrapone	CAPSULE;ORAL	012911-002	Aug 9, 1996		RX	Yes	Yes
Esteve	METOPIRONE	metyrapone	TABLET;ORAL	012911-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Overview and Financial Analysis of Metyrapone

Last updated: February 14, 2026

Metyrapone is an oral medication primarily used in diagnostic testing of adrenal function and in managing conditions like Cushing's syndrome. Its market environment is heavily influenced by its clinical applications, regulatory status, and patent landscape.

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What Are the Pharmacological and Clinical Uses of Metyrapone?

Metyrapone inhibits cortisol synthesis via 11-beta-hydroxylase enzyme blockade. Its primary usage is in adrenal testing, notably the metyrapone test to evaluate hypothalamic-pituitary-adrenal (HPA) axis function. It also functions off-label in managing hypercortisolism in endogenous Cushing's syndrome patients.

What Is the Current Market Size and Forecast for Metyrapone?

Market data is limited, as metyrapone is not widely marketed outside specialized hospitals. The global market for drugs used in diagnosing and treating adrenal dysfunction was estimated at approximately $200 million in 2022[1]. Metyrapone's revenue constitutes a subset of this, with standalone market estimates around $10-20 million, primarily driven by North America and Europe.

Projections suggest that growth in this niche will be modest, driven by:

• Increased awareness and testing for adrenal disorders.
• Off-label use in Cushing's syndrome, especially for cases resistant to other treatments.
• Limited adoption due to off-patent status and competition from alternative agents like ketoconazole or osilodrostat.

Forecasts show a compound annual growth rate (CAGR) of 3-4% from 2023 to 2028, reaching approximately $15-25 million globally.

Who Are the Major Players in the Metyrapone Market?

Metyrapone is largely available through compounding pharmacies or under hospital distribution channels, with original brand manufacturers largely phasing out commercial sales due to patent expiration. No new approved formulations have entered the market recently.

Existing suppliers include:

• Corcept Therapeutics: Produces relacorilant, an off-target cortisol modulator but not metyrapone.
• Other generic manufacturers and compounding pharmacies.

The lack of proprietary formulations means limited patent protection for metyrapone itself, constraining competitive barriers.

How Do Regulatory and Patents Influence Market Potential?

Metyrapone was developed in the 1950s. It is approved by the FDA for diagnostic testing but lacks marketing approval for therapeutic indications in the U.S. Outside the US, approval varies.

Patent expiry occurred decades ago, leading to a generic-dominated market. The absence of patent protection diminishes incentives for large-scale marketing or R&D investment.

Innovative formulations or novel delivery systems could unlock new indications, but such developments are absent currently.

What Are the Financial Implications of Patent and Regulatory Status?

Patent expiration around the late 1970s resulted in generic proliferation. Regulatory barriers are minimal for existing formulations, but lack of approval for new therapeutic indications limits revenue growth potential.

The cost of goods sold (COGS) for generics is low, typically below $1 per dose. Pricing varies but generally ranges from $20 to $50 per dose within hospital systems.

Reimbursements rely primarily on institutional budgets and insurance, with no significant direct to consumer marketing.

What Are the Opportunities and Risks in Future Market Development?

Opportunities:

• Development of new formulations or delivery mechanisms.
• Expansion into additional indications, such as Cushing's disease management.
• Conjugation with diagnostic tools for adrenal testing.

Risks:

• Competition from oral antifungals (ketoconazole, osilodrostat) with broader indications.
• Regulatory challenges if seeking FDA approval for therapeutic indications.
• Limited patent protection reduces exclusivity and investment appeal.

Summary of Market Dynamics

Aspect	Details
Market Size (2022)	$10-20 million globally
Growth Rate	3-4% CAGR (2023-2028)
Major Markets	North America, Europe
Key Players	Generic manufacturers, compounding pharmacies
Patent Status	Expired in the 1970s
Regulatory Status	FDA approved for diagnostics; off-label therapeutic use
Pricing	$20-$50 per dose
Market Drivers	Increased adrenal testing, Cushing's syndrome management

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Key Takeaways

• Metyrapone is a niche drug with limited but steady demand primarily in diagnostic testing and off-label Cushing's syndrome management.
• The market size remains small, constrained by broad generic availability and limited patent protection.
• Growth prospects depend on new formulation development and expanding therapeutic indications.
• Competition from alternative therapies poses significant challenges.
• Regulatory efforts could unlock further revenue if new indications receive approval.

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FAQs

1. Can metyrapone be used for Cushing's syndrome treatment?
It is used off-label for this purpose, particularly where other treatments fail or are contraindicated, but it lacks FDA approval as a therapeutic agent.

2. Is there patent protection that could be leveraged for commercial advantage?
No. The original patents expired in the 1970s, leading to a commodity-like market with low barriers to entry.

3. What regulatory hurdles exist for repurposing metyrapone?
Approval for new therapeutic indications requires clinical trials demonstrating safety and efficacy, which entails significant investment and regulatory review.

4. Who are the main competitors for metyrapone in adrenal testing?
Alternatives include aminoglutethimide and newer diagnostic agents; however, direct competitors in diagnostics are limited due to the niche market.

5. What is the potential for developing a branded formulation?
Limited, given the low overall demand, generic presence, and regulatory and patent barriers.

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References

[1] IQVIA. "Global Endocrinology Market Report," 2022.