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Last Updated: July 10, 2020

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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-seven suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.

US ANDA Litigation and Generic Entry Outlook for Clindesse

A generic version of CLINDESSE was approved as clindamycin phosphate by ALVOGEN INC on July 24th, 1987.

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Drug patent expirations by year for CLINDESSE
Drug Prices for CLINDESSE

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Drug Sales Revenue Trends for CLINDESSE

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Recent Clinical Trials for CLINDESSE

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SponsorPhase
Actavis Inc.Phase 3
Watson Laboratories, Inc.Phase 3

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Pharmacology for CLINDESSE
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

Supplementary Protection Certificates for CLINDESSE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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 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
1304992 2013/044 Ireland   Start Trial PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992 92401 Luxembourg   Start Trial PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992 CR 2013 00053 Denmark   Start Trial PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
McKesson
Dow
Baxter
Johnson and Johnson

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