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Last Updated: March 19, 2024

Ciclopirox - Generic Drug Details


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What are the generic drug sources for ciclopirox and what is the scope of freedom to operate?

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. Fifteen suppliers are listed for this compound.

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
Universidad Complutense de MadridPhase 4
Atlas Molecular PharmaPhase 1
BCDiabetes.CaN/A

See all ciclopirox clinical trials

Pharmacology for ciclopirox
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Bermuda PENLAC ciclopirox SOLUTION;TOPICAL 021022-001 Dec 17, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Padagis Us CICLOPIROX ciclopirox GEL;TOPICAL 078266-001 Jan 7, 2009 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Generics CICLOPIROX ciclopirox GEL;TOPICAL 091595-001 Feb 29, 2012 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc CICLOPIROX ciclopirox SOLUTION;TOPICAL 078975-001 Feb 17, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fougera Pharms CICLOPIROX ciclopirox GEL;TOPICAL 077896-001 Jun 10, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medimetriks Pharms LOPROX ciclopirox CREAM;TOPICAL 018748-001 Dec 30, 1982 ⤷  Try a Trial ⤷  Try a Trial
Bausch LOPROX ciclopirox SHAMPOO;TOPICAL 021159-001 Feb 28, 2003 ⤷  Try a Trial ⤷  Try a Trial
Valeant Bermuda PENLAC ciclopirox SOLUTION;TOPICAL 021022-001 Dec 17, 1999 ⤷  Try a Trial ⤷  Try a Trial
Medimetriks Pharms LOPROX ciclopirox SUSPENSION;TOPICAL 019824-001 Dec 30, 1988 ⤷  Try a Trial ⤷  Try a Trial
Bausch LOPROX ciclopirox SHAMPOO;TOPICAL 021159-001 Feb 28, 2003 ⤷  Try a Trial ⤷  Try a Trial
Alvogen CICLOPIROX ciclopirox GEL;TOPICAL 020519-001 Jul 21, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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