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Serving leading biopharmaceutical companies globally:

US Department of Justice
Chubb
Federal Trade Commission
Covington
AstraZeneca
Deloitte
Cipla
Citi
Mallinckrodt
McKesson

Generated: December 11, 2017

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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 ciclopirox freedom to operate?

Ciclopirox
is the generic ingredient in three branded drugs marketed by Fougera Pharms, G And W Labs Inc, Glenmark Pharms, Perrigo New York, Taro, Medimetriks Pharms, Cnty Line Pharms, Glenmark Generics, Paddock Llc, Actavis Mid Atlantic, Perrigo Co, Medicis, Akorn, Apotex Inc, Cipla Ltd, G And W Labs, Hi Tech Pharma, Mylan Pharms Inc, Taro Pharm Inds, Teva Pharms, Tolmar, and Valeant Bermuda, 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.

Ciclopirox has eighty-six patent family members in thirty-four countries.

There are ten drug master file entries for ciclopirox. Twenty-one suppliers are listed for this compound.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Apotex IncCICLOPIROXciclopiroxSOLUTION;TOPICAL078172-001Sep 18, 2007ATRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fougera PharmsCICLOPIROXciclopiroxSUSPENSION;TOPICAL076422-001Aug 6, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
MedicisLOPROXciclopiroxSHAMPOO;TOPICAL021159-001Feb 28, 2003ATRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Taro Pharm IndsCICLOPIROXciclopiroxSOLUTION;TOPICAL078144-001Sep 18, 2007ATRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fougera PharmsCICLOPIROXciclopiroxCREAM;TOPICAL076435-001Dec 29, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
TolmarCICLOPIROXciclopiroxSOLUTION;TOPICAL077687-001Sep 18, 2007ATRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Glenmark GenericsCICLOPIROXciclopiroxGEL;TOPICAL091595-001Feb 29, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Perrigo New YorkCICLOPIROXciclopiroxSOLUTION;TOPICAL077623-001Sep 18, 2007ATRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Perrigo New YorkCICLOPIROXciclopiroxSUSPENSION;TOPICAL077676-001Dec 15, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Valeant BermudaPENLACciclopiroxSOLUTION;TOPICAL021022-001Dec 17, 1999ATRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ciclopirox

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medimetriks PharmsLOPROXciclopiroxCREAM;TOPICAL018748-001Dec 30, 1982► Subscribe► Subscribe
Valeant BermudaPENLACciclopiroxSOLUTION;TOPICAL021022-001Dec 17, 1999► Subscribe► Subscribe
Medimetriks PharmsLOPROXciclopiroxSUSPENSION;TOPICAL019824-001Dec 30, 1988► Subscribe► Subscribe
MedicisLOPROXciclopiroxSHAMPOO;TOPICAL021159-001Feb 28, 2003► Subscribe► Subscribe
MedicisLOPROXciclopiroxSHAMPOO;TOPICAL021159-001Feb 28, 2003► Subscribe► Subscribe
Cnty Line PharmsCICLOPIROXciclopiroxGEL;TOPICAL020519-001Jul 21, 1997► Subscribe► Subscribe
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International Patent Family for Ingredient: ciclopirox

Country Document Number Estimated Expiration
Israel129140► Subscribe
Australia716208► Subscribe
Hong Kong1022267► Subscribe
World Intellectual Property Organization (WIPO)9813009► Subscribe
South Korea100494207► Subscribe
Czech Republic9901075► Subscribe
Cyprus2371► Subscribe
Bulgaria103260► Subscribe
Australia4774697► Subscribe
China1104231► 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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Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
Johnson and Johnson
Queensland Health
Accenture
McKesson
McKinsey
Argus Health
Fish and Richardson
Healthtrust

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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