Viewing data from:

OXISTAT

NDA

OXICONAZOLE NITRATE | N020209 | ANI 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

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis NCT01519752	Phase 1	Completed	Sun Pharmaceutical Industries, Inc.	661	2011-11 → 2012-11
Clinical Assessment of Oxiconazole Nitrate Solid Lipid Nanoparticles Loaded Gel NCT03823040	Phase 1	Completed	Minia University	28	2018-07-16 → 2018-12-30

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$11.37

per ml

Lowest NADAC/Unit

$11.37

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62559028560OXISTAT 1% LOTION	$11.37	ML	Brand	—	2026-01-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$453.32

Highest Price

$471.40

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
62559-0285-30OXISTAT 1% LOTION	$453.32	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0285-30OXISTAT 1% LOTION	$453.32	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0285-60OXISTAT 1% LOTION	$471.40	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0285-60OXISTAT 1% LOTION	$471.40	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain4 active DMFs1 inactive

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

SIEGFRIED LTDOXICONAZOLE NITRATE

DMF 55791984

HARMAN FINOCHEM LTDOXICONAZOLE NITRATE

DMF 236252010

TARO PHARMACEUTICAL INDUSTRIES LTDOXICONAZOLE NITRATE, MICRONIZED

DMF 262262012

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

2 letters from Drugs@FDA

Date	Submission	Document
May 25, 2022	SUPPL -14	View Letter (PDF)
Jan 29, 2004	SUPPL -5	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1% BASE

RLD

0 patents0 exclusivities▴

LOTION;TOPICAL | Approved: Sep 30, 1992

No patent or exclusivity listings for this strength.