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Serving leading biopharmaceutical companies globally:

Covington
Harvard Business School
Novartis
AstraZeneca
Farmers Insurance
US Army
Daiichi Sankyo
Julphar
Colorcon
Mallinckrodt

Generated: October 21, 2017

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, Actavis Labs Ut Inc, Perrigo Israel, Stiefel, Mylan Pharms Inc, Valeant Bermuda, and Tolmar, and is included in nine 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 sixteen patent family members in eleven countries and nine supplementary protection certificates in six countries.

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

Summary for Generic Name: benzoyl peroxide; clindamycin phosphate

US Patents:6
Tradenames:5
Applicants:7
NDAs:9
Drug Master File Entries: see list17
Suppliers / Packagers: see list10
Clinical Trials: see list1,010
Drug Prices:see low prices
DailyMed Link:benzoyl peroxide; clindamycin phosphate at DailyMed

Pharmacology for Ingredient: 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;TOPICAL050819-001Oct 23, 2008ABRXYesYes► Subscribe► Subscribe ► Subscribe
Dow Pharm
ACANYA
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-001Oct 23, 2008ABRXYesYes► Subscribe► Subscribe ► Subscribe
Perrigo Israel
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL202440-001Sep 21, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL065443-001Aug 11, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe
Tolmar
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL203688-001Aug 25, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Valeant Bermuda
BENZACLIN
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050756-001Dec 21, 2000ABRXYesYes► Subscribe► Subscribe► Subscribe
Dow Pharm
ACANYA
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-001Oct 23, 2008ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Stiefel
DUAC
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050741-001Aug 26, 2002ABRXYesYes► Subscribe► Subscribe► Subscribe
Valeant Bermuda
BENZACLIN
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050756-002Apr 20, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Actavis Labs Ut Inc
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL205128-001Jun 19, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: benzoyl peroxide; clindamycin phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Dow Pharm
ACANYA
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-001Oct 23, 2008► Subscribe► Subscribe
Stiefel
DUAC
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050741-001Aug 26, 2002► Subscribe► Subscribe
Dow Pharm
ONEXTON
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-002Nov 24, 2014► Subscribe► Subscribe
Dow Pharm
ACANYA
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-001Oct 23, 2008► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,693,988Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent► 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: benzoyl peroxide; clindamycin phosphate

Country Document Number Estimated Expiration
BrazilPI0913326► Subscribe
Russian Federation2493847► Subscribe
China102056481► Subscribe
South Africa201008265► Subscribe
Russian Federation2010146038► Subscribe
European Patent Office2299810► Subscribe
Australia2009255679► Subscribe
Japan2011522820► Subscribe
Mexico2010013152► Subscribe
World Intellectual Property Organization (WIPO)2009148584► 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: BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/054United Kingdom► SubscribePRODUCT 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
1458369/01Switzerland► SubscribePRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
C0042Belgium► SubscribePRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
C/GB05/029United Kingdom► SubscribePRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
C/GB10/005United Kingdom► SubscribePRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
2008000041Germany► SubscribePRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
00097Netherlands► SubscribePRODUCT 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
172Luxembourg► SubscribePRODUCT 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)
C/GB05/030United Kingdom► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Novartis
Federal Trade Commission
Cerilliant
Boehringer Ingelheim
Citi
Healthtrust
Argus Health
Express Scripts
Johnson and Johnson
US Army

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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