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Serving leading biopharmaceutical companies globally:

Argus Health
Chubb
Boehringer Ingelheim
UBS
Harvard Business School
Fish and Richardson
US Department of Justice
Cerilliant
US Army
Cantor Fitzgerald

Generated: December 17, 2017

DrugPatentWatch Database Preview

ZIANA Drug Profile

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Which patents cover Ziana, and what generic alternatives are available?

Ziana is a drug marketed by Medicis and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty-four patent family members in twenty-two countries and nine supplementary protection certificates in eight countries.

The generic ingredient in ZIANA is clindamycin phosphate; tretinoin. There are fifty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.

Summary for ZIANA

Drug patent expirations by year for ZIANA

Pharmacology for ZIANA

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
MedicisZIANAclindamycin phosphate; tretinoinGEL;TOPICAL050802-001Nov 7, 2006ABRXYesYes► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for ZIANA

Drugname Dosage Strength RLD Submissiondate
clindamycin phosphate and tretinoinGel1.2%/0.025%Ziana12/17/2010

Non-Orange Book Patents for Tradename: ZIANA

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
6,517,847 Topical gel delivery system► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ZIANA

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)0211683► Subscribe
Slovenia2052714► Subscribe
Japan4988129► Subscribe
Australia2001279002► Subscribe
MexicoPA03001006► Subscribe
South Korea100840169► Subscribe
South Africa200301037► Subscribe
Luxembourg92401► Subscribe
Poland360589► Subscribe
Denmark1304992► 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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Supplementary Protection Certificates for Tradename: ZIANA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
4Finland► Subscribe
2013025,C1304992Lithuania► SubscribePRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
13/044Ireland► SubscribePRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
2013 00053Denmark► SubscribePRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
2013025Lithuania► SubscribePRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
401Luxembourg► SubscribePRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
00617Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
90049-3Sweden► SubscribePRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
1304992/01Switzerland► SubscribePRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Daiichi Sankyo
Covington
Julphar
McKesson
US Army
Boehringer Ingelheim
Chubb
Moodys
Johnson and Johnson

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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