Benzoyl peroxide; clindamycin phosphate - Generic Drug Details

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What are the generic 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
Icahn School of Medicine at Mount Sinai	Phase 2
Valeant Pharmaceuticals International, Inc.	Phase 2
Bausch Health Americas, 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

Anatomical Therapeutic Chemical (ATC) Classes for benzoyl peroxide; clindamycin phosphate

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
Chartwell Rx	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	203688-001	Aug 25, 2016		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Encube	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	207194-001	Aug 19, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Israel	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	202440-001	Sep 21, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	210794-001	Dec 28, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Stiefel	DUAC	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050741-001	Aug 26, 2002	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Encube	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	204087-001	Jun 27, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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
Stiefel	DUAC	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050741-001	Aug 26, 2002	⤷ Sign Up	⤷ Sign Up
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	⤷ Sign Up	⤷ Sign Up
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	⤷ Sign Up	⤷ Sign Up
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	⤷ Sign Up	⤷ Sign Up
>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
European Patent Office	2299810	FORMULATIONS PHARMACEUTIQUES TOPIQUES CONTENANT UNE FAIBLE CONCENTRATION DE PEROXYDE DE BENZOYLE EN SUSPENSION DANS DE L'EAU ET UN SOLVANT ORGANIQUE MISCIBLE AVEC L'EAU (TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT)	⤷ Sign Up
Japan	5677693		⤷ Sign Up
Russian Federation	2013122395	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ	⤷ Sign Up
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)	⤷ Sign Up
South Africa	201008265	TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT	⤷ Sign Up
Russian Federation	2645087	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)	⤷ Sign Up
>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
1458369	122008000041	Germany	⤷ Sign Up	PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1586316	122011100019	Germany	⤷ Sign Up	PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
0186118	SPC/GB05/029	United Kingdom	⤷ Sign Up	PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
1586316	SPC/GB11/054	United Kingdom	⤷ Sign Up	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
0137963	97C0042	Belgium	⤷ Sign Up	PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
0591275	SPC/GB05/030	United Kingdom	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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