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CICLOPIROX

NDA

CICLOPIROX | N020519 | ALVOGEN 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

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 Ciclopirox (2023)

Total Spending

$28.7M

Total Claims

770,484

Beneficiaries

397,306

Avg Cost/Unit

$4.25

Spending Trend

$23.1M(2019)→$14.7M(2019)→$12.9M(2020)→$20.9M(2020)→$12.9M(2021)→$20.8M(2021)→$9K(2021)→$14.5M(2022)→$24.5M(2022)→$14.9M(2023)→$28.7M(2023)→$8K(2023)

YoY Change:+4.0%

5yr CAGR:+4.1%

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

API Supply Chain7 active DMFs4 inactive

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

OLON SPACICLOPIROX OLAMINE

DMF 113891995

ERREGIERRE SPACICLOPIROX OLAMINE USP-PH.EUR.

DMF 163522003

ERREGIERRE SPACICLOPIROX USP-EP

DMF 163532002

PCASCICLOPIROX

DMF 170072003

OLON SPACICLOPIROX

DMF 171562004

INTERQUIM SACICLOPIROX USP

DMF 189292005

KUMAR ORGANIC PRODUCTS LIMITEDCICLOPIROX OLAMINE

DMF 423042025

EUROAPI GERMANY GMBHInactiveCICLOPIROX

DMF 146271999

SANOFI AVENTIS DEUTSCHLAND GMBHInactiveCICLOPIROX OLAMINE

DMF 146331999

PIERRE FABRE MEDICAMENTInactiveCICLOPIROX

DMF 171992004

SYNKEM SASInactiveCICLOPIROX

DMF 173472004

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 2, 2013	SUPPL -16	View Letter (PDF)
Apr 15, 2003	SUPPL -5	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.77% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Jul 21, 1997

No patent or exclusivity listings for this strength.