Ciclopirox - Generic Drug Details

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What are the generic drug sources for ciclopirox and what is the scope of patent protection?

Ciclopirox is the generic ingredient in three branded drugs marketed by Cosette, Fougera Pharms, Glenmark Pharms, Perrigo Israel, Taro, Medimetriks Pharms, Cnty Line Pharms, Glenmark Generics, Paddock Llc, Actavis Mid Atlantic, Perrigo Co, Teligent, Bausch, Acella, Akorn, Anda Repository, Mylan Pharms Inc, Perrigo New York, Rising, Taro Pharm Inds, Teva Pharms, and Valeant Bermuda, and is included in thirty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for ciclopirox. Nineteen suppliers are listed for this compound.

Summary for ciclopirox

US Patents:	0
Tradenames:	3
Applicants:	22
NDAs:	32
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	9
Patent Applications:	6,733
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ciclopirox
Drug Sales Revenues:	Drug sales revenues for ciclopirox
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ciclopirox
What excipients (inactive ingredients) are in ciclopirox?	ciclopirox excipients list
DailyMed Link:	ciclopirox at DailyMed

See drug prices for ciclopirox

Drug Sales Revenue Trends for ciclopirox

See drug sales revenues for ciclopirox

Recent Clinical Trials for ciclopirox

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

Sponsor	Phase
Galderma	Phase 4
Federal University of São Paulo	Phase 4
University Health Network, Toronto	Phase 1

See all ciclopirox clinical trials

Pharmacology for ciclopirox

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

ATC Classes for ciclopirox

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

Paragraph IV (Patent) Challenges for CICLOPIROX

Tradename	Dosage	Ingredient	NDA	Submissiondate
CICLOPIROX	GEL;TOPICAL	ciclopirox	020519	2006-05-10

US Patents and Regulatory Information for ciclopirox

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Glossary

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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	CREAM;TOPICAL	076790-001	Apr 12, 2005	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Cnty Line Pharms	CICLOPIROX	ciclopirox	GEL;TOPICAL	020519-001	Jul 21, 1997	AB	RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Fougera Pharms	CICLOPIROX	ciclopirox	CREAM;TOPICAL	076435-001	Dec 29, 2004	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
Fougera Pharms	CICLOPIROX	ciclopirox	SUSPENSION;TOPICAL	076422-001	Aug 6, 2004	AB	RX	No	No	⤷ Try it Free	⤷ Try it Free				⤷ Try it Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ciclopirox

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Bermuda	PENLAC	ciclopirox	SOLUTION;TOPICAL	021022-001	Dec 17, 1999	⤷ Try it Free	⤷ Try it Free
Medimetriks Pharms	LOPROX	ciclopirox	CREAM;TOPICAL	018748-001	Dec 30, 1982	⤷ Try it Free	⤷ Try it Free
Cnty Line Pharms	CICLOPIROX	ciclopirox	GEL;TOPICAL	020519-001	Jul 21, 1997	⤷ Try it Free	⤷ Try it Free
Bausch	LOPROX	ciclopirox	SHAMPOO;TOPICAL	021159-001	Feb 28, 2003	⤷ Try it Free	⤷ Try it Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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