Is there a generic for Ciclopirox?

Yes. The FDA Orange Book lists 27 approved generic (ANDA) applications for Ciclopirox, referencing the brand LOPROX. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ciclopirox?

LOPROX (NDA 021159, BAUSCH) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Ciclopirox are approved?

Ciclopirox is approved in the following dosage forms: cream, gel, shampoo, solution, suspension.

FDA Orange Book · active-ingredient family

Ciclopirox

Ciclopirox: 5 brands, 27 generics; first approved Dec 30, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 27 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

LOPROXRLD
BAUSCHNDA 0211592003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SHAMPOO TOPICAL Discontinued —
PENLACRLD
VALEANT BERMUDANDA 0210221999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8% SOLUTION TOPICAL Discontinued —
CICLOPIROXRLD
ALVOGENNDA 0205191997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.77% GEL TOPICAL Discontinued —
LOPROXRLDRS
EUROFARMANDA 0198241988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.77% SUSPENSION TOPICAL Rx AB
LOPROXRLDRS
EUROFARMANDA 0187481982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.77% CREAM TOPICAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SHAMPOO	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8%	SOLUTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.77%	GEL	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.77%	SUSPENSION	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.77%	CREAM	TOPICAL	Rx	AB

Generic (ANDA) products (27)

Abbreviated applications

CICLOPIROX
ENCUBEANDA 2099752018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SHAMPOO TOPICAL Rx AT
CICLOPIROXRS
GLENMARK PHARMSANDA 0915952012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.77% GEL TOPICAL Rx AB
CICLOPIROX
SUN PHARMA CANADAANDA 0902692011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SHAMPOO TOPICAL Rx AT
CICLOPIROX
COSETTE PHARMS NCANDA 0784632010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.77% CREAM TOPICAL Rx AB
CICLOPIROX
FOUGERA PHARMSANDA 0901462010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SHAMPOO TOPICAL Rx AT
CICLOPIROX
EPIC PHARMA LLCANDA 0789752010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8% SOLUTION TOPICAL Discontinued —
CICLOPIROXRS
PADAGIS USANDA 0785942010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SHAMPOO TOPICAL Rx AT
CICLOPIROX
ACTAVIS MID ATLANTICANDA 0904902009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SHAMPOO TOPICAL Rx AT
CICLOPIROX
GLENMARK PHARMSANDA 0902732009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.77% CREAM TOPICAL Rx AB
CICLOPIROX
PADAGIS USANDA 0782662009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.77% GEL TOPICAL Rx AB
CICLOPIROX
FOUGERA PHARMSANDA 0778962008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.77% GEL TOPICAL Rx AB
CICLOPIROX
ACELLAANDA 0781722007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8% SOLUTION TOPICAL Rx AT
CICLOPIROX
CHARTWELL RXANDA 0780462007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8% SOLUTION TOPICAL Rx AT
CICLOPIROX
COSETTE PHARMS NCANDA 0782332007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8% SOLUTION TOPICAL Discontinued —
CICLOPIROX
ENCUBEANDA 0776872007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8% SOLUTION TOPICAL Rx AT
CICLOPIROX
HIKMAANDA 0782702007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8% SOLUTION TOPICAL Discontinued —
CICLOPIROX
MYLAN PHARMS INCANDA 0785672007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8% SOLUTION TOPICAL Discontinued —
CICLOPIROXRS
PADAGIS USANDA 0776232007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8% SOLUTION TOPICAL Rx AT
CICLOPIROX
RISINGANDA 0781242007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8% SOLUTION TOPICAL Rx AT
CICLOPIROX
TARO PHARM INDSANDA 0781442007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8% SOLUTION TOPICAL Discontinued —
CICLOPIROX
TEVA PHARMSANDA 0780792007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
8% SOLUTION TOPICAL Discontinued —
CICLOPIROX
PADAGIS ISRAELANDA 0776762006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.77% SUSPENSION TOPICAL Rx AB
CICLOPIROX
PADAGIS ISRAELANDA 0773642006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.77% CREAM TOPICAL Rx AB
CICLOPIROX
SUN PHARMA CANADAANDA 0770922005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.77% SUSPENSION TOPICAL Discontinued —
CICLOPIROX
SUN PHARMA CANADAANDA 0767902005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.77% CREAM TOPICAL Rx AB
CICLOPIROX
FOUGERA PHARMSANDA 0764352004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.77% CREAM TOPICAL Rx AB
CICLOPIROX
FOUGERA PHARMSANDA 0764222004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.77% SUSPENSION TOPICAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SHAMPOO	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.77%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SHAMPOO	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.77%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SHAMPOO	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8%	SOLUTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SHAMPOO	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SHAMPOO	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.77%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.77%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.77%	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8%	SOLUTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8%	SOLUTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8%	SOLUTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8%	SOLUTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
8%	SOLUTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.77%	SUSPENSION	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.77%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.77%	SUSPENSION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.77%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.77%	CREAM	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.77%	SUSPENSION	TOPICAL	Rx	AB

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Approval history

FDA approval span

First approval

Dec 30, 1982

44 yr 3 mo ago

Most recent approval

Apr 05, 2018

8 yr 6 mo ago

Approvals span 1982–2018 across 32 FDA applications.

Brand (NDA) 516%

Generic (ANDA) 2784%

Ciclopirox: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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