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Last Updated: August 19, 2022

ZIANA Drug Patent Profile


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When do Ziana patents expire, and what generic alternatives are available?

Ziana is a drug marketed by Bausch and is included in one NDA.

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.

Paragraph IV (Patent) Challenges for ZIANA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZIANA Gel clindamycin phosphate; tretinoin 1.2%/0.025% 050802 1 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
Bausch ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802-001 Nov 7, 2006 AB1 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ZIANA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802-001 Nov 7, 2006 See Plans and Pricing See Plans and Pricing
Bausch ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802-001 Nov 7, 2006 See Plans and Pricing See Plans and Pricing
Bausch ZIANA clindamycin phosphate; tretinoin GEL;TOPICAL 050802-001 Nov 7, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ZIANA

See the table below for patents covering ZIANA around the world.

Country Patent Number Title Estimated Expiration
Portugal 2052714 See Plans and Pricing
European Patent Office 2052714 Systemes de gel topiques destines au traitement des troubles de la peau (Topical gel delivery systems for treating skin disorders) See Plans and Pricing
Germany 60138549 See Plans and Pricing
Australia 2001279002 See Plans and Pricing
Brazil 0113247 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZIANA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 2013C/060 Belgium See Plans and Pricing PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992 132013902214376 Italy See Plans and Pricing PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
1304992 C01304992/01 Switzerland See Plans and Pricing PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992 PA2013025 Lithuania See Plans and Pricing 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 SPC/GB13/061 United Kingdom See Plans and Pricing PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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