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Last Updated: April 19, 2024

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, Padagis Israel, Taro, Medimetriks Pharms, Alvogen, Glenmark Generics, Padagis Us, Actavis Mid Atlantic, Encube, Bausch, Acella, Chartwell Rx, Epic Pharma Llc, Hikma, Mylan Pharms Inc, 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. Sixteen suppliers are listed for this compound.

Summary for ciclopirox

US Patents:	0
Tradenames:	3
Applicants:	21
NDAs:	32
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	13
Patent Applications:	6,718
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends 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

See drug prices for ciclopirox

Drug Sales Revenue Trends for ciclopirox

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Recent Clinical Trials for ciclopirox

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

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

Paragraph IV (Patent) Challenges for CICLOPIROX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CICLOPIROX	Gel	ciclopirox	0.77%	020519	1	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
Actavis Mid Atlantic	CICLOPIROX	ciclopirox	SHAMPOO;TOPICAL	090490-001	Nov 24, 2009	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Padagis Israel	CICLOPIROX	ciclopirox	SUSPENSION;TOPICAL	077676-001	Dec 15, 2006	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Pharms Inc	CICLOPIROX	ciclopirox	SOLUTION;TOPICAL	078567-001	Sep 18, 2007		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Taro	CICLOPIROX	ciclopirox	SUSPENSION;TOPICAL	077092-001	Aug 10, 2005	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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
Alvogen	CICLOPIROX	ciclopirox	GEL;TOPICAL	020519-001	Jul 21, 1997	⤷ Try a Trial	⤷ Try a Trial
Bausch	LOPROX	ciclopirox	SHAMPOO;TOPICAL	021159-001	Feb 28, 2003	⤷ Try a Trial	⤷ Try a Trial
Bausch	LOPROX	ciclopirox	SHAMPOO;TOPICAL	021159-001	Feb 28, 2003	⤷ Try a Trial	⤷ Try a Trial
Medimetriks Pharms	LOPROX	ciclopirox	CREAM;TOPICAL	018748-001	Dec 30, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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