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PENLAC

NDA

CICLOPIROX | N021022 | VALEANT INTERNATIONAL BERMUDA

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
Engel & Novitt, LLP - Citizen Petition FDA-2007-P-0349 · 12 docket documents Engel & Novitt, LLP filed this citizen petition on behalf of an unnamed client developing a generic ciclopirox 8% topical solution product competing with the reference listed drug Penlac. The petitioner requests that the FDA require all ANDA sponsors to measure and control benzene levels in a critic	505(q)	2008-05-13	Denied	—

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

Clinical Trials

12 trials from ClinicalTrials.gov, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Selenium Sulfide, Ketoconazole and Ciclopirox Shampoo as Additional Treatments for Tinea Capitis (Scalp Ringworm)NCT00127868	N/A	Completed	Chen, Catherine, M.D.	47	2005-03 → 2008-04
Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis NCT00802672	Phase 3	Completed	Padagis LLC	561	2003-12 → 2004-05
Topical Penlac Nail Lacquer for Onychomycosis in Children NCT01419847	Phase 4	Completed	Rady Children's Hospital, San Diego	40	2002-03 → 2006-05
Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus Ciclopirox Nail Lacquer NCT02679911	Phase 4	Completed	Galderma R&D	20	2015-09 → 2016-06
Safety and Equivalence of a Generic Ciclopirox Olamine Topical Suspension Compared to the Reference Ciclopirox Topical Suspension 0.77% for the Treatment of Tinea Pedis NCT00804193	N/A	Completed	Padagis LLC	553	2004-06 → 2005-04
Study to Evaluate the Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)NCT02866032	Phase 3	Completed	Moberg Pharma AB	452	2016-09 → 2020-06-10
Study Evaluating the Tolerance and Biologic Activity of Oral Ciclopirox Olamine in Patients With Relapsed or Refractory Hematologic Malignancy NCT00990587	Phase 1	Completed	University Health Network, Toronto	20	2009-10
Tacrolimus Ointment Interest (PROTOPIC ®) in the Maintenance Treatment of Severe Seborrheic Dermatitis NCT02004860	Phase 3	Completed	University Hospital, Rouen	120	2014-01 → 2017-10
Safety Study of Ciclopirox Olamine Cream for Dermatomycoses in Children NCT01646580	Phase 4	Terminated	Ferrer Internacional S.A.	21	2008-10 → 2011-11
Efficacy and Safety of Low-dose Oral Isotretinoin for Seborrhea NCT01139749	Phase 4	UNKNOWN	Federal University of São Paulo	50	2011-10 → 2012-12

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

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

4 letters from Drugs@FDA

Date	Submission	Document
Dec 8, 2004	SUPPL -4	View Letter (PDF)
Dec 24, 2003	SUPPL -3	View Letter (PDF)
Jun 22, 2003	SUPPL -2	View Letter (PDF)
Dec 17, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Dec 17, 1999

No patent or exclusivity listings for this strength.