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Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Colorcon
Boehringer Ingelheim
Express Scripts
McKinsey

Last Updated: December 4, 2023

CLINDESSE Drug Patent Profile


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When do Clindesse patents expire, and when can generic versions of Clindesse launch?

Clindesse is a drug marketed by Padagis Us 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. Thirty-three 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 ALMAJECT on July 24th, 1987.

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Paragraph IV (Patent) Challenges for CLINDESSE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CLINDESSE Vaginal Cream clindamycin phosphate 2% 050793 1 2015-02-05

US Patents and Regulatory Information for CLINDESSE

CLINDESSE is protected by two US patents.

Patents protecting CLINDESSE

Bioadhesive drug delivery system
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING BACTERIAL VAGINOSIS

Pharmaceutical delivery system
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING BACTERIAL VAGINOSIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Padagis Us CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Padagis Us CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 CLINDESSE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Padagis Us CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004 ⤷  Try a Trial ⤷  Try a Trial
Padagis Us CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004 ⤷  Try a Trial ⤷  Try a Trial
Padagis Us CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CLINDESSE

See the table below for patents covering CLINDESSE around the world.

Country Patent Number Title Estimated Expiration
Russian Federation 2320322 БИОАДГЕЗИВНАЯ СИСТЕМА ДОСТАВКИ ЛЕКАРСТВ (BIOADHESIVE SYSTEM FOR DELIVERING MEDICINAL PREPARATIONS) ⤷  Try a Trial
Portugal 977555 ⤷  Try a Trial
Australia 5922798 ⤷  Try a Trial
Canada 2278541 PREPARATIONS PHARMACEUTIQUES ET PROCEDES PERMETTANT DE LES ADMINISTRER LOCALEMENT (PHARMACEUTICAL PREPARATIONS AND METHODS FOR THEIR REGIONAL ADMINISTRATION) ⤷  Try a Trial
Japan S63501563 ⤷  Try a Trial
Australia 2006332519 Medicament for topical use ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CLINDESSE

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 C01304992/01 Switzerland ⤷  Try a Trial PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992 92401 Luxembourg ⤷  Try a Trial PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
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 122013000081 Germany ⤷  Try a 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 2013/044 Ireland ⤷  Try a Trial PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: 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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