Viewing data from:

OXISTAT

NDA

OXICONAZOLE NITRATE | N019828 | FOUGERA 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Oxistat (2023)

Total Spending

$335K

Total Claims

369

Beneficiaries

186

Avg Cost/Unit

$15.49

Spending Trend

$1.1M(2019)→$790K(2020)→$521K(2021)→$403K(2022)→$335K(2023)

YoY Change:-0.3%

5yr CAGR:+1.1%

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

API Supply Chain3 active DMFs1 inactive

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

SIEGFRIED LTDOXICONAZOLE NITRATE

DMF 55791984

HARMAN FINOCHEM LTDOXICONAZOLE NITRATE

DMF 236252010

METROCHEM API PRIVATE LTDOXICONAZOLE NITRATE

DMF 341732019

ERREGIERRE SPAInactiveOXICONAZOLE NITRATE

DMF 154032001

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 29, 2004	SUPPL -9	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1% BASE

RLDAB

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Dec 30, 1988

No patent or exclusivity listings for this strength.