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Generated: March 25, 2019

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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 patent protection?

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 seven 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
Perrigo Israel CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 202440-001 Sep 21, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Valeant Bermuda BENZACLIN benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050756-002 Apr 20, 2007 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 065443-001 Aug 11, 2009 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Valeant Bermuda BENZACLIN benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050756-001 Dec 21, 2000 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Tolmar CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 203688-001 Aug 25, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 ➤ Sign Up ➤ Sign Up
Dow Pharm ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 ➤ Sign Up ➤ Sign Up
Stiefel DUAC benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050741-001 Aug 26, 2002 ➤ Sign Up ➤ Sign Up
Dow Pharm ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0526708 C300097 Netherlands ➤ Sign Up PRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228
1667986 92172 Luxembourg ➤ Sign Up 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)
0186118 SPC/GB05/029 United Kingdom ➤ Sign Up PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
0591275 SPC/GB05/030 United Kingdom ➤ Sign Up 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
0137963 97C0042 Belgium ➤ Sign Up PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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