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Generated: October 19, 2018

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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 six patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for benzoyl peroxide; clindamycin phosphate. Ten 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
Dow Pharm ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 050756-001 Dec 21, 2000 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dow Pharm ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Taro CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 208776-001 May 25, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Tolmar CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 204087-001 Jun 27, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dow Pharm ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ 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
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
Dow Pharm ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for benzoyl peroxide; clindamycin phosphate

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2009148584 ➤ Sign Up
Brazil PI0913326 ➤ Sign Up
Japan 2011522820 ➤ Sign Up
Russian Federation 2645087 ➤ Sign Up
Japan 6006272 ➤ Sign Up
Mexico 2010013152 ➤ Sign Up
Canada 2723029 ➤ Sign Up
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for benzoyl peroxide; clindamycin phosphate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1458369/01 Switzerland ➤ Sign Up PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
00097 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
C/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
C/GB11/054 United Kingdom ➤ Sign Up PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523
C/GB10/005 United Kingdom ➤ Sign Up PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
2008000041 Germany ➤ Sign Up PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
172 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)
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
McKinsey
Fuji
McKesson
Mallinckrodt
Julphar
Deloitte
Boehringer Ingelheim

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