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Benzoyl peroxide; clindamycin phosphate - Generic Drug Details

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

This ingredient has sixteen patent family members in eleven countries.

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

Summary for Generic Name: benzoyl peroxide; clindamycin phosphate

Tradenames:5
Patents:6
Applicants:7
NDAs:8
Drug Master File Entries: see list17
Suppliers / Packagers: see list9
Clinical Trials: see list456
Formulation / Manufacturing:see details
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dow Pharm
ACANYA
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-001Oct 23, 2008RXYesYes9,078,870► subscribeY ► subscribe
Mylan Pharms Inc
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL065443-001Aug 11, 2009RXNoNo► subscribe► subscribe
Dow Pharm
ONEXTON
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-002Nov 24, 2014RXYesYes9,504,704► 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
Stiefel
DUAC
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050741-001Aug 26, 20025,466,446► 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
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International Patent Family for Ingredient: benzoyl peroxide; clindamycin phosphate

Country Document Number Estimated Expiration
Canada2723029► subscribe
South Africa201008265► subscribe
Japan6006272► 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/GB05/030United 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/GB10/005United Kingdom► subscribePRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
C0042Belgium► subscribePRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
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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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