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NIZORAL

NDA

KETOCONAZOLE | N019927 | 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition From Public Citizen's Health Research Group FDA-2015-P-0578 · 5 docket documents Public Citizen, a consumer advocacy organization, filed this citizen petition pursuant to 21 U.S.C. § 355(e) and 21 C.F.R. § 10.30 on February 24, 2015, requesting that the FDA immediately remove oral ketoconazole from the market because the antifungal drug's risks of fatal liver failure, adrenal in	Other	2015-02-25	Denied	Public Citizen's Health Research Group

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

161 trials from ClinicalTrials.gov — 2 recruiting, 3 active, 126 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer NCT00859781	Phase 2	Active	Weill Medical College of Cornell University	55	2009-06 → 2026-09
Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women NCT04037605	Early Phase 1	Active	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	5	2020-02-09 → 2026-06-24
Hormonal Mechanisms of Sleep Restriction - Axis Study NCT03142893	Phase 1	Active	Peter y. Liu	80	2017-05-08 → 2026-06-30
Azoles Targeting Recurrent High Grade Gliomas NCT03763396	Early Phase 1	Not Yet Recruiting	University Health Network, Toronto	30	2024-06-01 → 2027-06
Alternation in the Human Microbiome With Commonly Used Topical Medications NCT03437005	Phase 1	Recruiting	University of California, Davis	24	2013-01-28 → 2026-09-28
Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer NCT00003084	Phase 2	Completed	M.D. Anderson Cancer Center	75	1997-12 → 2002-11
Estimation Of Effect Of Ketoconazole On Pharmacokinetics Of Crizotinib In Healthy Volunteers NCT01149785	Phase 1	Completed	Pfizer	15	2010-07 → 2010-09
A Phase 1/2a Study of the 2S,4R Enantiomer of Ketoconazole in Subjects With Type 2 Diabetes Mellitus NCT00302224	Phase 1/2	Completed	DiObex	50	2005-02 → 2006-08
Study Evaluating The Safety And Tolerability Of Administration Of Single Oral Doses Of SAM-760 To Healthy Subjects NCT00948662	Phase 1	Completed	Pfizer	124	2009-09 → 2010-12
A Pilot Study of the Treatment of Central Serous Chorioretinopathy With Ketoconazole NCT00211393	Phase 2	Completed	Manhattan Eye, Ear & Throat Hospital	5	2005-05 → 2008-04

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

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

STHREE CHEMICALS 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
Oct 30, 2013	SUPPL -32	View Letter (PDF)
Dec 5, 2012	SUPPL -31	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SHAMPOO;TOPICAL | Approved: Aug 31, 1990

No patent or exclusivity listings for this strength.