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SPORANOX

NDA

ITRACONAZOLE | N020657 | 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Strides Pharma, Inc. FDA-2026-P-4021 · 4 docket documents Strides Pharma, Inc. filed this citizen petition under Section 505(j) requesting that the FDA determine whether SPORANOX (itraconazole) Oral Solution, 10mg/mL, NDA 020657, held by Janssen Pharmaceuticals Inc., was withdrawn from commercial distribution for safety or efficacy reasons or only for comm	505(q)	2026-04-13	Open	Strides Pharma, Inc.

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

Clinical Trials

216 trials from ClinicalTrials.gov — 4 recruiting, 1 active, 186 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia NCT04067336	Phase 1/2	Active	Kura Oncology, Inc.	263	2019-09-12 → 2028-10-16
A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma NCT03460977	Phase 1	Recruiting	Pfizer	453	2018-04-17 → 2029-07-07
Chronic Pulmonary Aspergillosis and Ambisome Aerosol with Itraconazole NCT03656081	Phase 3	Recruiting	Poitiers University Hospital	224	2018-12-19 → 2029-12
Signal TrAnsduction Pathway Activity Analysis in OVarian cancER NCT03458221	Phase 2/3	Recruiting	Gynaecologisch Oncologisch Centrum Zuid	148	2023-01-31 → 2026-10-01
Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer NCT04018872	Phase 2	Recruiting	Dallas VA Medical Center	78	2019-06-24 → 2026-09-29
A Study to Evaluate the Effect of Fluconazole and Itraconazole on Erdafitinib Pharmacokinetics in Healthy Adult Participants NCT03135106	Phase 1	Completed	Janssen Research & Development, LLC	54	2017-04-14 → 2017-09-01
First in Human Study to Investigate the Safety and Tolerability, Pharmacokinetics, Itraconazole Drug-drug-interaction and Food Effect of BAY1817080 NCT02817100	Phase 1	Completed	Bayer	88	2016-07-22 → 2017-08-23
This Study in Healthy Men Tests How Itraconazole Influences the Amount of BI 1015550 in the Blood NCT03403439	Phase 1	Completed	Boehringer Ingelheim	16	2018-05-03 → 2018-07-20
To Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of Olaparib, and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation to Patients With Advanced Solid Tumours NCT01900028	Phase 1	Completed	AstraZeneca	85	2013-10 → 2016-09
Relative Bioavailability, Safety, Tolerability, Pharmacokinetics (PK) and Food Effect Study of GSK2140944 in Healthy Subjects NCT02045849	Phase 1	Completed	GlaxoSmithKline	46	2014-01-28 → 2014-08-21

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

API Supply Chain11 active DMFs6 inactive

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

JANSSEN PHARMACEUTICA NVITRACONAZOLE (R051211) DRUG SUBSTANCE

DMF 107251994

W R GRACE AND CO -CONNITRACONAZOLE USP & PH EUR

DMF 126971997

QUIMICA SINTETICA SAITRACONAZOLE

DMF 130121998

NEULAND LABORATORIES LTDITRACONAZOLE USP

DMF 154452001

MATRIX PHARMACORP PRIVATE LTDITRACONAZOLE USP

DMF 177392004

ALIVUS LIFE SCIENCES LTDITRACONAZOLE USP

DMF 179462004

SMS PHARMACEUTICALS LTDITRACONAZOLE USP

DMF 255142011

COHANCE LIFESCIENCES LTDITRACONAZOLE USP

DMF 259862012

MURLI KRISHNA PHARMA PVT LTDITRACONAZOLE PELLETS 22.0 % W/W

DMF 274102013

VASUDHA PHARMA CHEM LTDITRACONAZOLE USP

DMF 352612020

LEE PHARMA LTDITRACONAZOLE USP

DMF 414562025

QUIMICA FINA FARMEX SA DE CVInactiveITRACONAZOLE

DMF 145071999

HETERO DRUGS LTDInactiveITRACONAZOLE

DMF 157282001

PIRAMAL HEALTHCARE LTDInactiveITRACONAZOLE

DMF 169052003

APOTECNIA SAInactiveITRACONAZOLE

DMF 172922004

SOCIETA ITALIANA MEDICINALI SCANDICCIInactiveITRACONAZOLE

DMF 179212004

ALP PHARM BEIJING CO LTDInactiveITRACONAZOLE (DRUG SUBSTANCE, NON-STERILE)

DMF 236412010

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

Approval Letters

26 letters from Drugs@FDA

Date	Submission	Document
Jul 8, 2026	SUPPL -45	View Letter (PDF)
Dec 20, 2024	SUPPL -43	View Letter (PDF)
Oct 29, 2024	SUPPL -44	View Letter (PDF)
Mar 19, 2024	SUPPL -42	View Letter (PDF)
Feb 7, 2024	SUPPL -40	View Letter (PDF)
Oct 20, 2023	SUPPL -39	View Letter (PDF)
Dec 6, 2022	SUPPL -38	View Letter (PDF)
Mar 11, 2019	SUPPL -37	View Letter (PDF)
Oct 12, 2017	SUPPL -36	View Letter (PDF)
Mar 24, 2017	SUPPL -35	View Letter (PDF)
Apr 17, 2015	SUPPL -33	View Letter (PDF)
Jun 11, 2014	SUPPL -32	View Letter (PDF)
Mar 27, 2012	SUPPL -27	View Letter (PDF)
Mar 27, 2012	SUPPL -28	View Letter (PDF)
Apr 19, 2011	SUPPL -26	View Letter (PDF)
Jan 7, 2011	SUPPL -25	View Letter (PDF)
Aug 3, 2010	SUPPL -24	View Letter (PDF)
Mar 10, 2009	SUPPL -11	View Letter (PDF)
Mar 10, 2009	SUPPL -21	View Letter (PDF)
Mar 10, 2009	SUPPL -19	View Letter (PDF)
Mar 10, 2009	SUPPL -18	View Letter (PDF)
Sep 30, 2003	SUPPL -10	View Letter (PDF)
Sep 11, 2002	SUPPL -7	View Letter (PDF)
Jul 17, 2002	SUPPL -8	View Letter (PDF)
Apr 17, 2001	SUPPL -4	View Letter (PDF)
Apr 17, 2001	SUPPL -5	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Feb 21, 1997

No patent or exclusivity listings for this strength.