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Serving leading biopharmaceutical companies globally:

Colorcon
Chinese Patent Office
McKinsey
Moodys
McKesson
Deloitte
QuintilesIMS
Boehringer Ingelheim
Merck
Fish and Richardson

Generated: December 12, 2017

DrugPatentWatch Database Preview

CLINDESSE Drug Profile

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Which patents cover Clindesse, 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 thirty-six patent family members in twenty countries and six supplementary protection certificates in six countries.

The generic ingredient in CLINDESSE is clindamycin phosphate. There are fifty-three drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.
Drug patent expirations by year for CLINDESSE

Pharmacology for CLINDESSE

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Perrigo Pharma IntlCLINDESSEclindamycin phosphateCREAM;VAGINAL050793-001Nov 30, 2004RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Perrigo Pharma IntlCLINDESSEclindamycin phosphateCREAM;VAGINAL050793-001Nov 30, 2004RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for CLINDESSE

Drugname Dosage Strength RLD Submissiondate
clindamycin phosphateVaginal Cream2%Clindesse2/5/2015

Non-Orange Book Patents for Tradename: CLINDESSE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,416,778 Pharmaceutical preparations and methods for their regional administration► Subscribe
6,652,874 Pharmaceutical preparations and methods for their regional administration► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: CLINDESSE

Country Document Number Estimated Expiration
European Patent Office2316424► Subscribe
China102048689► Subscribe
South Korea20080098576► Subscribe
Japan2010138196► Subscribe
Russian Federation2320322► Subscribe
Denmark0977555► Subscribe
Hungary0203102► Subscribe
Japan2001511773► Subscribe
Japan4462818► Subscribe
Russian Federation2004130870► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: CLINDESSE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992/01Switzerland► SubscribePRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
401Luxembourg► SubscribePRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
2013 00053Denmark► SubscribePRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
00617Netherlands► SubscribePRODUCT 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
2013025,C1304992Lithuania► SubscribePRODUCT 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
13/044Ireland► SubscribePRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Baxter
Argus Health
Healthtrust
Boehringer Ingelheim
McKesson
Fish and Richardson
Merck
Chubb
Federal Trade Commission
Deloitte

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 verifification 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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