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Last Updated: April 19, 2024

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 freedom to operate?

Benzoyl peroxide; clindamycin phosphate is the generic ingredient in five branded drugs marketed by Bausch, Actavis Labs Ut Inc, Chartwell Rx, Encube, Glenmark Pharms, Mylan Pharms Inc, Padagis Israel, Taro, Zydus Pharms, and Stiefel, and is included in eighteen NDAs. There are nine 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 twenty patent family members in fourteen countries.

Fourteen suppliers are listed for this compound.

Summary for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

International Patents:	20
US Patents:	9
Tradenames:	5
Applicants:	10
NDAs:	18
Finished Product Suppliers / Packagers:	14
Clinical Trials:	12
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
DailyMed Link:	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE at DailyMed

Recent Clinical Trials for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bausch Health Americas, Inc.	Phase 2
Icahn School of Medicine at Mount Sinai	Phase 2
Valeant Pharmaceuticals International, Inc.	Phase 2

See all BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE clinical trials

Pharmacology for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Drug Class	Lincosamide Antibacterial
Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

Paragraph IV (Patent) Challenges for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ONEXTON	Gel	benzoyl peroxide; clindamycin phosphate	1.2%/3.75%	050819	1	2015-09-30
ONEXTON	Gel	benzoyl peroxide; clindamycin phosphate	1.2%/2.5%	050819	1	2012-12-20
DUAC	Gel	benzoyl peroxide; clindamycin phosphate	1% / 5%	050741	1	2008-12-11

US Patents and Regulatory Information for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Encube	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	207194-001	Aug 19, 2019		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Zydus Pharms	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	210794-001	Dec 28, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Taro	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	206218-001	Dec 15, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Stiefel	DUAC	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050741-001	Aug 26, 2002	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	⤷ Try a Trial	⤷ Try a Trial
Stiefel	DUAC	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050741-001	Aug 26, 2002	⤷ Try a Trial	⤷ Try a Trial
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	⤷ Try a Trial	⤷ Try a Trial
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

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Country	Patent Number	Title	Estimated Expiration
Russian Federation	2013122395	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ	⤷ Try a Trial
Russian Federation	2010146038	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ	⤷ Try a Trial
Russian Federation	2493847	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ (PHARMACEUTICAL FORMULATIONS FOR LOCAL APPLICATION CONTAINING LOW CONCENTRATIONS OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND WATER-MISCIBLE ORGANIC SOLVENT)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2009148584		⤷ Try a Trial
Australia	2009255679	Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent	⤷ Try a Trial
Japan	5677693		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1586316	122011100019	Germany	⤷ Try a Trial	PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
0591275	SPC/GB05/030	United Kingdom	⤷ Try a Trial	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
1458369	CA 2008 00029	Denmark	⤷ Try a Trial	PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
1458369	C01458369/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
0526708	C300097	Netherlands	⤷ Try a Trial	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
1586316	SPC/GB11/054	United Kingdom	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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 verification 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.