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. 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.
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Questions you can ask:
- What is the 5 year forecast for ZIANA?
- What are the global sales for ZIANA?
- What is Average Wholesale Price for ZIANA?
Summary for ZIANA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Patent Applications: | 11 |
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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | ZIANA | clindamycin phosphate; tretinoin | GEL;TOPICAL | 050802-001 | Nov 7, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | ZIANA | clindamycin phosphate; tretinoin | GEL;TOPICAL | 050802-001 | Nov 7, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Canada | 2417646 | SYSTEME DE DISTRIBUTION D'UN GEL TOPIQUE (TOPICAL GEL DELIVERY SYSTEM) | ⤷ Sign Up |
China | 101305982 | ⤷ Sign Up | |
Japan | 2004505900 | ⤷ Sign Up | |
South Korea | 20080036246 | ⤷ Sign Up | |
Denmark | 1304992 | ⤷ Sign Up | |
Poland | 213237 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZIANA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1304992 | 474 | Finland | ⤷ Sign Up | |
1304992 | 2013C/060 | Belgium | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506 |
1304992 | 132013902214376 | Italy | ⤷ Sign Up | 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 | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014 |
1304992 | PA2013025 | Lithuania | ⤷ Sign Up | 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 | PA2013025,C1304992 | Lithuania | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |