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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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 |
|---|---|---|---|
| Australia | 2001279002 | ⤷ Sign Up | |
| Slovenia | 2052714 | ⤷ Sign Up | |
| Luxembourg | 92401 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 0211683 | ⤷ Sign Up | |
| European Patent Office | 2052714 | Systemes de gel topiques destines au traitement des troubles de la peau (Topical gel delivery systems for treating skin disorders) | ⤷ Sign Up |
| China | 1460013 | ⤷ Sign Up | |
| China | 101305982 | ⤷ 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 | 2013C/060 | Belgium | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506 |
| 1304992 | 92401 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE |
| 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 | 474 | Finland | ⤷ Sign Up | |
| 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 |
| 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 | SPC/GB13/061 | United Kingdom | ⤷ Sign Up | 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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