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Ciclopirox - Generic Drug Details

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Ciclopirox is the generic ingredient in three branded drugs marketed by Cnty Line Pharms, Valeant Bermuda, Fougera Pharms, Perrigo New York, Cipla Ltd, Medimetriks Pharms, G And W Labs, Taro Pharm Inds, Actavis Mid Atlantic, Medicis, G And W Labs Inc, Perrigo, Paddock Llc, Mylan Pharms Inc, Taro, Hi Tech Pharma, Apotex Inc, Glenmark Pharms, Versapharm, Teva Pharms, Tolmar, and Glenmark Generics, and is included in thirty-one NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has eighty-two patent family members in thirty-four countries.

There are ten drug master file entries for ciclopirox. Twenty-one suppliers are listed for this compound.

Summary for Generic Name: ciclopirox

Tradenames:3
Patents:4
Applicants:22
NDAs:31
Drug Master File Entries: see list10
Suppliers / Packaging: see list21
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: ciclopirox

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
CICLOPIROX
ciclopirox
SOLUTION;TOPICAL078567-001Sep 18, 2007DISCNNo► subscribe► subscribe
Perrigo
CICLOPIROX
ciclopirox
CREAM;TOPICAL077364-001Mar 3, 2006RXNo► subscribe► subscribe
Hi Tech Pharma
CICLOPIROX
ciclopirox
SOLUTION;TOPICAL078270-001Sep 18, 2007RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: ciclopirox

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cnty Line Pharms
LOPROX
ciclopirox
GEL;TOPICAL020519-001Jul 21, 19977,026,337► subscribe
Medimetriks Pharms
LOPROX
ciclopirox
SUSPENSION;TOPICAL019824-001Dec 30, 19883,883,545► subscribe
Medimetriks Pharms
LOPROX
ciclopirox
CREAM;TOPICAL018748-001Dec 30, 19823,883,545► subscribe
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International Patent Family for Ingredient: ciclopirox

Country Document Number Estimated Expiration
Japan2001501609► subscribe
South Korea100457850► subscribe
Taiwan519491► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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