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Generated: December 12, 2017

DrugPatentWatch Database Preview

CLINDAMYCIN PHOSPHATE - Generic Drug Details

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What are the generic sources for clindamycin phosphate and what is the scope of clindamycin phosphate freedom to operate?

Clindamycin phosphate
is the generic ingredient in seventeen branded drugs marketed by Perrigo Uk Finco, Mylan Pharms Inc, Pharmacia And Upjohn, Fougera Pharms, Perrigo Pharma Intl, Precision Dermat, Abraxis Pharm, Alvogen Inc, Bedford, Bristol Myers Squibb, Fresenius Kabi Usa, Igi Labs Inc, Loch, Marsam Pharms Llc, Mylan Labs Ltd, Sagent Pharms, Solopak, Teva Parenteral, Watson Labs, West-ward Pharms Int, Akorn Inc, Baxter Hlthcare Corp, Sandoz Inc, Abbvie, Baxter Hlthcare, Paddock Llc, Boca Pharma Llc, Fougera Pharms Inc, G And W Labs Inc, Novast Labs Ltd, Perrigo New York, Taro Pharm Inds, Teligent Pharma Inc, Vintage Pharms, Wockhardt, Akorn, Perrigo Co, Actavis Mid Atlantic, Aqua Pharms Llc, and Medicis, and is included in sixty-nine NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clindamycin phosphate has one hundred and twenty-four patent family members in thirty-six countries and nine supplementary protection certificates in eight countries.

There are fifty-three drug master file entries for clindamycin phosphate. Thirty-four suppliers are listed for this compound.

Pharmacology for CLINDAMYCIN PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Sandoz IncCLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINERclindamycin phosphateINJECTABLE;INJECTION201692-002May 31, 2012APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Fougera PharmsCLINDAMYCIN PHOSPHATEclindamycin phosphateCREAM;VAGINAL065139-001Dec 27, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Bristol Myers SquibbCLINDAMYCIN PHOSPHATEclindamycin phosphateINJECTABLE;INJECTION062908-001Feb 1, 1989DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Akorn IncCLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINERclindamycin phosphateINJECTABLE;INJECTION203048-003Apr 4, 2013APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Vintage PharmsCLINDAMYCIN PHOSPHATEclindamycin phosphateSOLUTION;TOPICAL062930-001Jun 28, 1989DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AbbvieCLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINERclindamycin phosphateINJECTABLE;INJECTION065027-001Jun 29, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
SolopakCLINDAMYCIN PHOSPHATEclindamycin phosphateINJECTABLE;INJECTION062852-001Mar 17, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncEVOCLINclindamycin phosphateAEROSOL, FOAM;TOPICAL050801-001Oct 22, 2004ATRXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Pharmacia And UpjohnCLEOCINclindamycin phosphateSUPPOSITORY;VAGINAL050767-001Aug 13, 1999RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Akorn IncCLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINERclindamycin phosphateINJECTABLE;INJECTION203048-001Apr 4, 2013APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: clindamycin phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Perrigo Pharma IntlCLINDESSEclindamycin phosphateCREAM;VAGINAL050793-001Nov 30, 2004► Subscribe► Subscribe
Perrigo Pharma IntlCLINDESSEclindamycin phosphateCREAM;VAGINAL050793-001Nov 30, 2004► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: clindamycin phosphate

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
7,749,488Pharmaceutical foam► Subscribe
6,652,874 Pharmaceutical preparations and methods for their regional administration► Subscribe
6,517,847 Topical gel delivery system► Subscribe
9,486,394Pharmaceutical foam► Subscribe
8,586,008Pharmaceutical foam► 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 Ingredient: clindamycin phosphate

Country Document Number Estimated Expiration
Japan2006515362► Subscribe
Portugal1304992► Subscribe
Serbia20050557► Subscribe
Israel214118► Subscribe
Germany69834025► Subscribe
Portugal102854► Subscribe
MexicoPA05007722► Subscribe
Canada2417646► Subscribe
South Korea20080036246► Subscribe
Panama8499101► 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: CLINDAMYCIN PHOSPHATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2013025Lithuania► SubscribePRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
4Finland► Subscribe
90049-3Sweden► SubscribePRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR 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
401Luxembourg► SubscribePRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992/01Switzerland► SubscribePRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
13/044Ireland► SubscribePRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
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
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fuji
Dow
Chinese Patent Office
Julphar
McKesson
UBS
Merck
Harvard Business School
US Department of Justice

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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