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Details for Generic Name: benzoyl peroxide; clindamycin phosphate

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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, and Valeant Bermuda, and is included in seven NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has fourteen patent family members in ten countries.

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

Summary for Generic Name: benzoyl peroxide; clindamycin phosphate

Tradenames:5
Patents:4
Applicants:6
NDAs:7
Drug Master File Entries: see list17
Suppliers / Packaging: see list9

Pharmacology for Ingredient: benzoyl peroxide; clindamycin phosphate

Clinical Trials for: benzoyl peroxide; clindamycin phosphate

Study Comparing Clindamycin Phosphate and Benzoyl Peroxide Gel to Acanya® Gel and Both to a Vehicle Control in the Treatment of Acne Vulgaris
Status: Completed Condition: Acne Vulgaris

Evaluate Therapeutic Equivalence and Safety of Two Clindamycin Phosphate and Benzoyl Peroxide Gels in Acne Vulgaris
Status: Completed Condition: Acne Vulgaris

A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne
Status: Recruiting Condition: Acne Vulgaris

To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel
Status: Recruiting Condition: Acne Vulgaris

Compare the Tolerance of Clindamycin 1% /Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications
Status: Completed Condition: Acne Vulgaris

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Labs Ut Inc
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL205128-001Jun 19, 2015RXNo<disabled><disabled>
Perrigo Israel
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL202440-001Sep 21, 2015RXNo<disabled><disabled>
Mylan Pharms Inc
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL065443-001Aug 11, 2009RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: benzoyl peroxide; clindamycin phosphate

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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<disabled>
Stiefel
DUAC
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050741-001Aug 26, 20025,466,446<disabled>
Dow Pharm
ACANYA
benzoyl peroxide; clindamycin phosphate
GEL;TOPICAL050819-001Oct 23, 20086,117,843<disabled>
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International Patent Family for Ingredient: benzoyl peroxide; clindamycin phosphate

Country Document Number Publication Date
Australia2009255679Dec 10, 2009
Japan2011522820Aug 04, 2011
World Intellectual Property Organization (WIPO)2009148584Dec 10, 2009
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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