Ziana Drug Patent Profile
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Which patents cover Ziana, and when can generic versions of Ziana launch?
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. Six suppliers are listed for this compound. Additional details are available on the clindamycin phosphate; tretinoin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ziana
A generic version of Ziana was approved as clindamycin phosphate; tretinoin by ACTAVIS MID ATLANTIC on June 12th, 2015.
Summary for Ziana
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Patent Applications: | 14 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for Ziana |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for Ziana |
What excipients (inactive ingredients) are in Ziana? | Ziana excipients list |
DailyMed Link: | Ziana at DailyMed |
Pharmacology for Ziana
Drug Class | Lincosamide Antibacterial Retinoid |
Physiological Effect | Decreased Sebaceous Gland Activity |
Anatomical Therapeutic Chemical (ATC) Classes for Ziana
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>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 | ⤷ Try a Trial | ⤷ Try a Trial |
Bausch | ZIANA | clindamycin phosphate; tretinoin | GEL;TOPICAL | 050802-001 | Nov 7, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Bausch | ZIANA | clindamycin phosphate; tretinoin | GEL;TOPICAL | 050802-001 | Nov 7, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Australia | 2001279002 | ⤷ Try a Trial | |
Luxembourg | 92401 | ⤷ Try a Trial | |
Spain | 2326955 | ⤷ Try a Trial | |
Denmark | 1304992 | ⤷ Try a Trial | |
Spain | 2437321 | ⤷ Try a Trial | |
Germany | 60138549 | ⤷ Try a Trial | |
Denmark | 2052714 | ⤷ Try a Trial | |
>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 | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506 |
1304992 | CR 2013 00053 | Denmark | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322 |
1304992 | SPC/GB13/061 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624 |
1304992 | C300617 | Netherlands | ⤷ Try a Trial | PRODUCT 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 |
1304992 | 1390049-3 | Sweden | ⤷ Try a Trial | PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322 |
1304992 | 474 | Finland | ⤷ Try a Trial | |
1304992 | 92401 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |