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CLINDESSE Drug Profile
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When do Clindesse patents expire, and when can generic versions of Clindesse launch?
Clindesse is a drug marketed by Perrigo Pharma Intl and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has forty-four patent family members in twenty-one countries.
The generic ingredient in CLINDESSE is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Clindesse
A generic version of CLINDESSE was approved as clindamycin phosphate by ALVOGEN on July 24th, 1987.
Summary for CLINDESSE
International Patents: | 44 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 47 |
Clinical Trials: | 1 |
Patent Applications: | 2,797 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for CLINDESSE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CLINDESSE |
What excipients (inactive ingredients) are in CLINDESSE? | CLINDESSE excipients list |
DailyMed Link: | CLINDESSE at DailyMed |



Recent Clinical Trials for CLINDESSE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Watson Laboratories, Inc. | Phase 3 |
Actavis Inc. | Phase 3 |
Pharmacology for CLINDESSE
Drug Class | Lincosamide Antibacterial |
Physiological Effect | Decreased Sebaceous Gland Activity |
Paragraph IV (Patent) Challenges for CLINDESSE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
CLINDESSE | CREAM;VAGINAL | clindamycin phosphate | 050793 | 2015-02-05 |
US Patents and Regulatory Information for CLINDESSE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Perrigo Pharma Intl | CLINDESSE | clindamycin phosphate | CREAM;VAGINAL | 050793-001 | Nov 30, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Perrigo Pharma Intl | CLINDESSE | clindamycin phosphate | CREAM;VAGINAL | 050793-001 | Nov 30, 2004 | 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 |
Expired US Patents for CLINDESSE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Perrigo Pharma Intl | CLINDESSE | clindamycin phosphate | CREAM;VAGINAL | 050793-001 | Nov 30, 2004 | Start Trial | Start Trial |
Perrigo Pharma Intl | CLINDESSE | clindamycin phosphate | CREAM;VAGINAL | 050793-001 | Nov 30, 2004 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for CLINDESSE
Country | Patent Number | Estimated Expiration |
---|---|---|
Brazil | PI0620905 | Start Trial |
Japan | 2003286193 | Start Trial |
Australia | 2004274000 | Start Trial |
Canada | 2278541 | Start Trial |
World Intellectual Property Organization (WIPO) | 9832422 | Start Trial |
World Intellectual Property Organization (WIPO) | 03079981 | Start Trial |
Canada | 2392473 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for CLINDESSE
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 | PA2013025,C1304992 | Lithuania | Start Trial | 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 | 2013/044 | Ireland | Start Trial | PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322 |
1304992 | 2013C/060 | Belgium | Start Trial | PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506 |
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 | C300617 | Netherlands | Start 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 | SPC/GB13/061 | United Kingdom | Start Trial | 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 |