CICLOPIROX Drug Patent Profile

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Ciclopirox is a drug marketed by Cosette, Fougera Pharms, Glenmark Pharms, Padagis Israel, Taro, Alvogen, Glenmark Pharms Inc, Padagis Us, Actavis Mid Atlantic, Encube, Acella, Chartwell Rx, Epic Pharma Llc, Hikma, Mylan Pharms Inc, Rising, Taro Pharm Inds, and Teva Pharms. and is included in twenty-eight NDAs.

The generic ingredient in CICLOPIROX is ciclopirox. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.

A generic version of CICLOPIROX was approved as ciclopirox by FOUGERA PHARMS on August 6^th, 2004.

US Patents:	0
Applicants:	18
NDAs:	28
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	13
Patent Applications:	5,211
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CICLOPIROX
Drug Sales Revenues:	Drug sales revenues for CICLOPIROX
What excipients (inactive ingredients) are in CICLOPIROX?	CICLOPIROX excipients list
DailyMed Link:	CICLOPIROX at DailyMed

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Universidad Complutense de Madrid	Phase 4
Atlas Molecular Pharma	Phase 1
BCDiabetes.Ca	N/A

Mechanism of Action	Protein Synthesis Inhibitors
Physiological Effect	Decreased DNA Replication Decreased Protein Synthesis Decreased RNA Replication

D01AE	Other antifungals for topical use
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AX	Other antiinfectives and antiseptics
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CICLOPIROX	Gel	ciclopirox	0.77%	020519	1	2006-05-10

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	CICLOPIROX	ciclopirox	SUSPENSION;TOPICAL	077092-001	Aug 10, 2005	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cosette	CICLOPIROX	ciclopirox	CREAM;TOPICAL	078463-001	Dec 20, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Encube	CICLOPIROX	ciclopirox	SOLUTION;TOPICAL	077687-001	Sep 18, 2007	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro Pharm Inds	CICLOPIROX	ciclopirox	SOLUTION;TOPICAL	078144-001	Sep 18, 2007	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fougera Pharms	CICLOPIROX	ciclopirox	GEL;TOPICAL	077896-001	Jun 10, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Israel	CICLOPIROX	ciclopirox	CREAM;TOPICAL	077364-001	Mar 3, 2006	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alvogen	CICLOPIROX	ciclopirox	GEL;TOPICAL	020519-001	Jul 21, 1997	⤷ Sign Up	⤷ Sign Up
Alvogen	CICLOPIROX	ciclopirox	GEL;TOPICAL	020519-001	Jul 21, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

See the table below for patents covering CICLOPIROX around the world.

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Country	Patent Number	Title	Estimated Expiration
Austria	216882		⤷ Sign Up
Norway	321899		⤷ Sign Up
Malaysia	117863	ANTIMYCOTIC AGENTS HAVING HIGH ACTIVE COMPOUND RELEASE	⤷ Sign Up
China	1231609		⤷ Sign Up
European Patent Office	0928192	GEL ANTIMYCOTIQUE A FORTE LIBERATION DE PRINCIPE ACTIF (ANTIMYCOTIC GEL WITH HIGH ACTIVE SUBSTANCE RELEASE)	⤷ Sign Up
Yugoslavia	13599		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration