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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Healthtrust
Moodys
Deloitte
Chinese Patent Office
Baxter
US Army
Johnson and Johnson
Chubb
Teva

Generated: February 25, 2018

DrugPatentWatch Database Preview

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, G And W Labs, Hi Tech Pharma, Ingenus Pharms Llc, Mylan Pharms Inc, Taro Pharm Inds, Teva Pharms, Tolmar, and Valeant Bermuda, and is included in thirty-one NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ciclopirox has forty-three patent family members in thirty-four countries.

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

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
Actavis Mid Atlantic CICLOPIROX ciclopirox SHAMPOO;TOPICAL 090490-001 Nov 24, 2009 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Fougera Pharms CICLOPIROX ciclopirox GEL;TOPICAL 077896-001 Jun 10, 2008 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Taro Pharm Inds CICLOPIROX ciclopirox SOLUTION;TOPICAL 078144-001 Sep 18, 2007 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc CICLOPIROX ciclopirox SOLUTION;TOPICAL 078172-001 Sep 18, 2007 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Perrigo New York CICLOPIROX ciclopirox SOLUTION;TOPICAL 077623-001 Sep 18, 2007 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Valeant Bermuda PENLAC ciclopirox SOLUTION;TOPICAL 021022-001 Dec 17, 1999 AT RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Mid Atlantic CICLOPIROX ciclopirox SOLUTION;TOPICAL 078046-001 Sep 18, 2007 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Fougera Pharms CICLOPIROX ciclopirox SHAMPOO;TOPICAL 090146-001 May 25, 2010 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Perrigo Co CICLOPIROX ciclopirox SHAMPOO;TOPICAL 078594-001 Feb 16, 2010 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Medimetriks Pharms LOPROX ciclopirox CREAM;TOPICAL 018748-001 Dec 30, 1982 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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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 ➤ Sign Up ➤ Sign Up
Medicis LOPROX ciclopirox SHAMPOO;TOPICAL 021159-001 Feb 28, 2003 ➤ Sign Up ➤ Sign Up
Valeant Bermuda PENLAC ciclopirox SOLUTION;TOPICAL 021022-001 Dec 17, 1999 ➤ Sign Up ➤ Sign Up
Medimetriks Pharms LOPROX ciclopirox SUSPENSION;TOPICAL 019824-001 Dec 30, 1988 ➤ Sign Up ➤ Sign Up
Cnty Line Pharms CICLOPIROX ciclopirox GEL;TOPICAL 020519-001 Jul 21, 1997 ➤ Sign Up ➤ Sign Up
Medicis LOPROX ciclopirox SHAMPOO;TOPICAL 021159-001 Feb 28, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for ciclopirox

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,026,337 Antimycotic gel having high active compound release ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for ciclopirox

Country Document Number Estimated Expiration
New Zealand 334849 ➤ Sign Up
Poland 188840 ➤ Sign Up
Hungary 9903804 ➤ Sign Up
South Korea 20000048620 ➤ Sign Up
Czech Republic 291170 ➤ Sign Up
Hungary 228297 ➤ Sign Up
Spain 2176702 ➤ Sign Up
China 1149992 ➤ Sign Up
Cyprus 2371 ➤ Sign Up
Germany 19639816 ➤ Sign Up
Country Document Number Estimated Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Mallinckrodt
Moodys
Chubb
Colorcon
Harvard Business School
Farmers Insurance
Cantor Fitzgerald
Citi

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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