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Last Updated: February 28, 2020

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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. Four suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.

US ANDA Litigation and Generic Entry Outlook for Ziana

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ZIANA
Drug Prices for ZIANA

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Recent Litigation for ZIANA

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District Court Litigation
Case NameDate
Bayer Healthcare Pharmaceuticals, Inc. v. River's Edge Pharmaceuticals, LLC2011-05-19
Medicis Pharmaceutical Corporation v. Actavis Mid Atlantic LLC2011-05-11
Medicis Pharmaceutical Corporation v. Acella Pharmaceuticals, LLC2010-08-19

See all ZIANA litigation

Pharmacology for ZIANA
Synonyms for ZIANA
337954-93-5
clindamycin phosphate - tretinoin formulation
Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel
Clindamycin phosphate and tretinoin
Clindamycin phosphate mixture with Tretinoin
L-threo-alpha-D-galacto-Octopyranoside, methyl 7-chloro-6,7,8-trideoxy-6-((((2S,4R)-1-methyl-4-propyl-2-pyrrolidinyl)carbonyl)amino)-1-thio-, 2-(dihydrogen phosphate), mixted with retinoic acid
LS-187913
Retinoic acid, mixt with methyl 7-chloro-6,7,8-trideoxy-6-((((2S,4R)-1-methyl-4-propyl-2-pyrrolidinyl)carbonyl)amino)-1-thio-L-threo-alpha-D-galacto-octopyranoside 2-(dihydrogen phosphate)
Velac
Veltin [Drug]
Paragraph IV (Patent) Challenges for ZIANA
Tradename Dosage Ingredient NDA Submissiondate
ZIANA GEL;TOPICAL clindamycin phosphate; tretinoin 050802 2010-12-17

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   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ZIANA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 132013902214376 Italy   Start Trial PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
1304992 PA2013025,C1304992 Lithuania   Start Trial PRODUCT 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
1304992 PA2013025 Lithuania   Start 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
1304992 122013000081 Germany   Start Trial PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992 2013C/060 Belgium   Start Trial PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Medtronic
McKesson
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Dow

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