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Federal Trade Commission
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Generated: May 23, 2018

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.

The generic ingredient in ZIANA is clindamycin phosphate; tretinoin. There are fifty-five 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.

US Patents and Regulatory Information for ZIANA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medicis ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802-001 Nov 7, 2006 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 ZIANA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicis ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802-001 Nov 7, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Medicis ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802-001 Nov 7, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for ZIANA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Gel 1.2%/0.025% ➤ Subscribe 2010-12-17

Non-Orange Book US Patents for 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 ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ZIANA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90049-3 Sweden ➤ Try a Free Trial PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
1304992/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
2013025 Lithuania ➤ Try a Free Trial PRODUCT 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
4 Finland ➤ Try a Free Trial
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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