Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 15, 2019

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

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

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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 92401 Luxembourg   Start Trial PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
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 2013/044 Ireland   Start Trial PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992 C01304992/01 Switzerland   Start Trial PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992 2013C/060 Belgium   Start Trial PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
Express Scripts
Moodys
Johnson and Johnson
Dow

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