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Last Updated: May 26, 2022

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

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING BACTERIAL VAGINOSIS

Pharmaceutical delivery system
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Padagis Us CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Padagis Us CLINDESSE clindamycin phosphate CREAM;VAGINAL 050793-001 Nov 30, 2004 See Plans and Pricing See Plans and Pricing
>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
Argentina 039037 UN SISTEMA DE LIBERACION DE UNA DROGA VAGINAL CON UN PH ESENCIALMENTE NEUTRO Y UN METODO PARA TRATAR UNA ENFERMEDAD VAGINAL QUE COMPRENDE DICHO SISTEMA See Plans and Pricing
European Patent Office 0977555 PREPARATIONS PHARMACEUTIQUES ET PROCEDES PERMETTANT DE LES ADMINISTRER LOCALEMENT (PHARMACEUTICAL PREPARATIONS AND METHODS FOR THEIR REGIONAL ADMINISTRATION) See Plans and Pricing
World Intellectual Property Organization (WIPO) 9832422 See Plans and Pricing
European Patent Office 0244405 VAGINAL DELIVERY SYSTEMS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CLINDESSE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 PA2013025,C1304992 Lithuania See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992 C300617 Netherlands See Plans and Pricing 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 C01304992/01 Switzerland See Plans and Pricing PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
>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

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.