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LYSODREN

NDA

MITOTANE | N016885 | ESTEVE PHARMACEUTICALS SA

1 strength0 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
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma NCT06487481	Phase 1	Recruiting	National Cancer Institute (NCI)	32	2026-07-07 → 2040-12-01

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

Medicare Part D Spending

CMS annual spending data for Lysodren (2023)

Total Spending

$2.3M

Total Claims

983

Beneficiaries

173

Avg Cost/Unit

$13.02

Spending Trend

$1.1M(2019)→$1.6M(2020)→$1.4M(2021)→$2.0M(2022)→$2.3M(2023)

YoY Change:+9.5%

5yr CAGR:+11.2%

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

API Supply Chain1 active DMF

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

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDMITOTANE

DMF 239472010

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

Approval Letters

8 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.