Ciclopirox

Sold as Loprox, Ciclopirox, Penlac. Every FDA application for this active ingredient: 5 branded and 27 generic.

As of Nov 15, 2026, FDA lists 32 applications for Ciclopirox (sold as Loprox, Ciclopirox, Penlac), first approved Dec 30, 1982, with 0 new uses approved and 0 published complete response letters.

First approved: Dec 30, 1982
Applications: 32
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $44.9M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Ciclopirox	Part D	$44.9M	+13%	756,406
Ciclodan	Part D	$0K	-65%	15

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

CICLOPIROX 0.77% CREAM: $0.168 per GMGeneric · -6% in a year
CICLOPIROX 0.77% GEL: $0.834 per GMGeneric · -19% in a year
CICLOPIROX 0.77% TOPICAL SUSP: $0.758 per MLGeneric · +13% in a year
CICLOPIROX 1% SHAMPOO: $0.193 per MLGeneric · -19% in a year
CICLOPIROX 8% SOLUTION: $1.17 per MLGeneric · -17% in a year

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Treatment of congenital erythropoietic porphyriaAtlas Molecular Pharma S.L. · designated Apr 17, 2018

Clinical Trials

2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


A Study to Investigate the Improvement of Photosensitivity in Terms of Skin Lesions Associated With CEP Following Administration of Oral ATL-001 (Ciclopirox Oral Solution) in Participants Aged >18 Years of Age With CEPCongenital Erythropoietic Porphyria (CEP) · Atlas Molecular Pharma	Phase 1 / Phase 2	Recruiting	Jun 17, 2025
Study in Patients With Onychomycosis Treated With Mycoclear® and CiclopiroxOnychomycosis of Toenails · University of Bologna	—	Not yet recruiting	May 14, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 30, 1982	LoproxNDA 18748 · New molecular entity	Eurofarma	10	Marketed
Dec 30, 1988	LoproxNDA 19824 · New dosage form	Eurofarma	10	Marketed
Jul 21, 1997	CiclopiroxNDA 20519 · New dosage form	Alvogen	6	Discontinued
Dec 17, 1999	PenlacNDA 21022 · New dosage form	Valeant Bermuda	4	Discontinued
Feb 28, 2003	LoproxNDA 21159 · New dosage form	Bausch	6	Discontinued
Aug 6, 2004	CiclopiroxANDA 76422	Fougera Pharms	1	Marketed
Dec 29, 2004	CiclopiroxANDA 76435	Fougera Pharms	0	Marketed
Apr 12, 2005	CiclopiroxANDA 76790	Sun Pharma Canada	2	Marketed
Aug 10, 2005	CiclopiroxANDA 77092	Sun Pharma Canada	1	Discontinued
Mar 3, 2006	CiclopiroxANDA 77364	Padagis Israel	2	Marketed
Dec 15, 2006	CiclopiroxANDA 77676	Padagis Israel	1	Marketed
Sep 18, 2007	CiclopiroxANDA 77623	Padagis US	0	Marketed
Sep 18, 2007	CiclopiroxANDA 77687	Encube	0	Marketed
Sep 18, 2007	CiclopiroxANDA 78046	Chartwell Rx	0	Marketed
Sep 18, 2007	CiclopiroxANDA 78079	Teva Pharms	0	Discontinued
Sep 18, 2007	CiclopiroxANDA 78124	Rising	0	Marketed
Sep 18, 2007	CiclopiroxANDA 78144	Taro Pharm Inds	0	Discontinued
Sep 18, 2007	CiclopiroxANDA 78172	Acella	0	Marketed
Sep 18, 2007	CiclopiroxANDA 78233	Cosette Pharms Nc	0	Discontinued
Sep 18, 2007	CiclopiroxANDA 78270	Hikma	0	Discontinued
Sep 18, 2007	CiclopiroxANDA 78567	Mylan Pharms Inc	0	Discontinued
Jun 10, 2008	CiclopiroxANDA 77896	Fougera Pharms	1	Marketed
Jan 7, 2009	CiclopiroxANDA 78266	Padagis US	1	Marketed
Nov 10, 2009	CiclopiroxANDA 90273	Glenmark Pharms	2	Marketed
Nov 24, 2009	CiclopiroxANDA 90490	Actavis Mid Atlantic	2	Marketed
Feb 16, 2010	CiclopiroxANDA 78594	Padagis US	1	Marketed
Feb 17, 2010	CiclopiroxANDA 78975	Epic Pharma LLC	0	Discontinued
May 25, 2010	CiclopiroxANDA 90146	Fougera Pharms	1	Marketed
Dec 20, 2010	CiclopiroxANDA 78463	Cosette Pharms Nc	1	Marketed
Feb 23, 2011	CiclopiroxANDA 90269	Sun Pharma Canada	2	Marketed
Feb 29, 2012	CiclopiroxANDA 91595	Glenmark Pharms	1	Marketed
Apr 5, 2018	CiclopiroxANDA 209975	Encube	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA