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METOPIRONE

NDA

METYRAPONE | N012911 | ESTEVE PHARMACEUTICALS SA

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Metyrapone Study for Patients Diagnosed With Mild Autonomous Cortisol Secretion - MACS NCT07138274	Phase 2	Not Yet Recruiting	Mayo Clinic	90	2026-08 → 2031-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Metopirone (2023)

Total Spending

$1.1M

Total Claims

109

Beneficiaries

Avg Cost/Unit

$46.32

Spending Trend

$242K(2019)→$525K(2020)→$867K(2021)→$1.1M(2022)→$1.1M(2023)

YoY Change:+15.8%

5yr CAGR:+20.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SCHWEIZERHALL MANUFACTURING COInactiveMETYRAPONE

DMF 146501999

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jul 26, 2023	SUPPL -39	View Letter (PDF)
Sep 9, 2022	SUPPL -38	View Letter (PDF)
Feb 21, 2020	SUPPL -36	View Letter (PDF)
Oct 23, 2018	SUPPL -35	View Letter (PDF)
Mar 4, 2014	SUPPL -33	View Letter (PDF)
Nov 8, 2010	SUPPL -26	View Letter (PDF)
May 7, 2004	SUPPL -23	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 250MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 250MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 9, 1996