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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Argus Health
Merck
Chinese Patent Office
Teva
UBS
QuintilesIMS
Baxter
Fish and Richardson

Generated: July 16, 2018

DrugPatentWatch Database Preview

Benzoyl peroxide; clindamycin phosphate - Generic Drug Details

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

Benzoyl peroxide; clindamycin phosphate
is the generic ingredient in five branded drugs marketed by Dow Pharm, Valeant Bermuda, Actavis Labs Ut Inc, Mylan Pharms Inc, Perrigo Israel, Taro, Taro Pharms, Tolmar, and Stiefel, and is included in twelve NDAs. There are six patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Benzoyl peroxide; clindamycin phosphate has seventeen patent family members in eleven countries.

There are seventeen drug master file entries for benzoyl peroxide; clindamycin phosphate. Eleven suppliers are listed for this compound.
Pharmacology for benzoyl peroxide; clindamycin phosphate

US Patents and Regulatory Information for benzoyl peroxide; clindamycin phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Bermuda BENZACLIN benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050756-001 Dec 21, 2000 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Dow Pharm ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Taro CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 208683-001 Jun 5, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 065443-001 Aug 11, 2009 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for benzoyl peroxide; clindamycin phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Dow Pharm ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Dow Pharm ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Dow Pharm ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Stiefel DUAC benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050741-001 Aug 26, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for benzoyl peroxide; 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
9,693,988 Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for benzoyl peroxide; clindamycin phosphate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB05/030 United Kingdom ➤ Try a Free Trial PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221
C/GB05/029 United Kingdom ➤ Try a Free Trial PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
2008000041 Germany ➤ Try a Free Trial PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
172 Luxembourg ➤ Try a Free Trial PRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
US Army
Queensland Health
Citi
Accenture
Johnson and Johnson
McKesson
Mallinckrodt
McKinsey

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