Viewing data from:

NIZORAL

NDA

KETOCONAZOLE | N018533 | JANSSEN PHARMACEUTICALS INC

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
Ketoconazole Effects on the Daily Cortisol Rhythm in Mild Autonomous Cortisol Secretion NCT07649317	Phase 1	Recruiting	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	36	2026-07-07 → 2027-12-31

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

Medicare Part D Spending

CMS annual spending data for Ketoconazole* (2023)

Total Spending

$96.1M

Total Claims

3,659,442

Beneficiaries

1,750,875

Avg Cost/Unit

$0.43

Spending Trend

$98.3M(2019)→$89.6M(2020)→$10K(2020)→$91.6M(2021)→$22K(2021)→$32K(2022)→$94.8M(2022)→$96.1M(2023)→$28K(2023)

YoY Change:-12.5%

5yr CAGR:-8.1%

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

API Supply Chain7 active DMFs8 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

JANSSEN PHARMACEUTICA NVKETOCONAZOLE DRUG SUBSTANCE

DMF 100371993

QUIMICA SINTETICA SAKETOCONAZOLE

DMF 120231996

DERIVADOS QUIMICOS SAUKETOCONAZOLE

DMF 147942001

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)KETOCONAZOLE

DMF 162122002

PIRAMAL PHARMA LTDKETOCONAZOLE

DMF 172902004

SHARON BIO MEDICINE LTDKETOCONAZOLE USP

DMF 250132011

SS PHARMA LLCKETOCONAZOLE USP

DMF 384172023

QUIMICA SINTETICA SAInactiveKETOCONAZOLE

DMF 97181992

ESTEVE QUIMICA SAInactiveKETOCONAZOLE

DMF 115791995

ALBEMARLE CORPInactiveKETOCONAZOLE

DMF 121711996

QUIMICA FINA FARMEX SA DE CVInactiveKETOCONAZOLE

DMF 127941997

NAPP TECHNOLOGIES INCInactiveKETOCONAZOLE USP

DMF 149482000

RECORDATI ESPANA SLInactiveKETOCONAZOLE

DMF 159602002

FDC LTDInactiveKETOCONAZOLE

DMF 168022003

GUFIC BIOSCIENCES LTDInactiveKETOCONAZOLE USP

DMF 169152003

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 27, 2014	SUPPL -41	View Letter (PDF)
Jul 29, 2013	SUPPL -40	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.