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Last Updated: July 6, 2020

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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 Pharma Inc, Bausch, Acella, Akorn, Anda Repository, Hi Tech Pharma, Mylan Pharms Inc, Novast Labs, Perrigo New York, 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. Seventeen 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
GaldermaPhase 4
Federal University of São PauloPhase 4
The Leukemia and Lymphoma SocietyPhase 1

See all ciclopirox clinical trials

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 SHAMPOO;TOPICAL 090269-001 Feb 23, 2011 AT RX No No   Start Trial   Start Trial   Start Trial
Perrigo Israel CICLOPIROX ciclopirox CREAM;TOPICAL 077364-001 Mar 3, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Cnty Line Pharms CICLOPIROX ciclopirox GEL;TOPICAL 020519-001 Jul 21, 1997 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Teligent Pharma Inc CICLOPIROX ciclopirox SHAMPOO;TOPICAL 209975-001 Apr 5, 2018 AT RX No No   Start Trial   Start Trial   Start Trial
Paddock Llc CICLOPIROX ciclopirox GEL;TOPICAL 078266-001 Jan 7, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Mid Atlantic CICLOPIROX ciclopirox SHAMPOO;TOPICAL 090490-001 Nov 24, 2009 AT RX No No   Start Trial   Start Trial   Start Trial
Taro CICLOPIROX ciclopirox CREAM;TOPICAL 076790-001 Apr 12, 2005 AB 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

Expired US Patents for ciclopirox

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

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Serving leading biopharmaceutical companies globally:

Medtronic
Colorcon
McKinsey
Johnson and Johnson
Mallinckrodt
Baxter

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