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Last Updated: July 6, 2020

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CICLOPIROX Drug Profile


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When do Ciclopirox patents expire, and when can generic versions of Ciclopirox launch?

Ciclopirox is a drug marketed by Cosette, Fougera Pharms, Glenmark Pharms, Perrigo Israel, Taro, Cnty Line Pharms, Glenmark Generics, Paddock Llc, Actavis Mid Atlantic, Perrigo Co, Teligent Pharma Inc, Acella, Akorn, Anda Repository, Hi Tech Pharma, Mylan Pharms Inc, Novast Labs, Perrigo New York, 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. Seventeen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.

US ANDA Litigation and Generic Entry Outlook for Ciclopirox

A generic version of CICLOPIROX was approved as ciclopirox by CNTY LINE PHARMS on July 21st, 1997.

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Drug patent expirations by year for CICLOPIROX
Drug Prices for CICLOPIROX

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Drug Sales Revenue Trends for CICLOPIROX

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Recent Clinical Trials for CICLOPIROX

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SponsorPhase
GaldermaPhase 4
Federal University of São PauloPhase 4
University Health Network, TorontoPhase 1

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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

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   Start Trial   Start Trial   Start Trial
Cosette CICLOPIROX ciclopirox CREAM;TOPICAL 078463-001 Dec 20, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Anda Repository CICLOPIROX ciclopirox SOLUTION;TOPICAL 077687-001 Sep 18, 2007 AT RX No No   Start Trial   Start Trial   Start Trial
Taro Pharm Inds CICLOPIROX ciclopirox SOLUTION;TOPICAL 078144-001 Sep 18, 2007 AT RX No No   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Boehringer Ingelheim
Express Scripts
Moodys
Mallinckrodt

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