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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Cipla
QuintilesIMS
Queensland Health
US Army
Merck
Accenture
Fish and Richardson
Cantor Fitzgerald
Moodys

Generated: June 24, 2017

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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 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 eight 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 sixteen patent family members in eleven 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

Tradenames:5
Patents:7
Applicants:7
NDAs:8
Drug Master File Entries: see list17
Suppliers / Packagers: see list10
Clinical Trials: see list981
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
Mylan Pharms Inc
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL065443-001Aug 11, 2009ABRXNoNo► Subscribe► Subscribe
Actavis Labs Ut Inc
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL205128-001Jun 19, 2015ABRXNoNo► Subscribe► Subscribe
Perrigo Israel
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL090979-001Jun 26, 2012ABRXNoNo► Subscribe► Subscribe
Dow Pharm
ONEXTON
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-002Nov 24, 2014RXYesYes8,288,434► SubscribeY ► Subscribe
Dow Pharm
ACANYA
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-001Oct 23, 2008ABRXYesYes8,288,434► SubscribeY ► 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, 20085,733,886► Subscribe
Dow Pharm
ONEXTON
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-002Nov 24, 20145,733,886► Subscribe
Dow Pharm
ACANYA
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-001Oct 23, 20086,117,843► Subscribe
Stiefel
DUAC
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050741-001Aug 26, 20025,466,446► Subscribe
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International Patent Family for Ingredient: benzoyl peroxide; clindamycin phosphate

Country Document Number Estimated Expiration
European Patent Office2299810► Subscribe
Japan5677693► Subscribe
South Africa201008265► Subscribe
Russian Federation2013122395► Subscribe
South Korea20110014651► 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/GB05/029United Kingdom► SubscribePRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
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
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
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)
1458369/01Switzerland► SubscribePRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
Julphar
Johnson and Johnson
AstraZeneca
Merck
Chubb
Deloitte
Dow
Harvard Business School

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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