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Last Updated: April 26, 2024

Benzoyl peroxide - Generic Drug Details

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What are the generic drug sources for benzoyl peroxide and what is the scope of patent protection?

Benzoyl peroxide is the generic ingredient in ten branded drugs marketed by Galderma Labs Lp, Bausch, Actavis Labs Ut Inc, Chartwell Rx, Encube, Glenmark Pharms, Mylan Pharms Inc, Padagis Israel, Taro, Zydus Pharms, Stiefel, Biofrontera, Valeant Intl, and Lyne, and is included in twenty-four NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Benzoyl peroxide has twenty-eight patent family members in eleven countries.

There are seven drug master file entries for benzoyl peroxide. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for benzoyl peroxide

International Patents:	28
US Patents:	22
Tradenames:	10
Applicants:	14
NDAs:	24
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	107
Patent Applications:	5,591
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for benzoyl peroxide
What excipients (inactive ingredients) are in benzoyl peroxide?	benzoyl peroxide excipients list
DailyMed Link:	benzoyl peroxide at DailyMed

See drug prices for benzoyl peroxide

Drug Sales Revenue Trends for benzoyl peroxide

See drug sales revenues for benzoyl peroxide

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for benzoyl peroxide

Generic Entry Date for benzoyl peroxide^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial Dosage: CREAM;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for benzoyl peroxide

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

Sponsor	Phase
South Valley University	N/A
University of Missouri-Columbia	Phase 4
University of Oklahoma	Phase 3

See all benzoyl peroxide clinical trials

Generic filers with tentative approvals for BENZOYL PEROXIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	3.75%; EQ 1.2% BASE	GEL;TOPICAL
⤷ Try a Trial	⤷ Try a Trial	UNKNOWN	UNKNOWN

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for benzoyl peroxide

D10AE	Peroxides
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

US Patents and Regulatory Information for benzoyl peroxide

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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
Valeant Intl	BENZAMYCIN	benzoyl peroxide; erythromycin	GEL;TOPICAL	050557-001	Oct 26, 1984	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Padagis Israel	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	090979-001	Jun 26, 2012	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Encube	ERYTHROMYCIN AND BENZOYL PEROXIDE	benzoyl peroxide; erythromycin	GEL;TOPICAL	065112-001	Mar 29, 2004		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
Galderma Labs Lp	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		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

International Patents for benzoyl peroxide

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Country	Patent Number	Title	Estimated Expiration
Australia	2006274541	Metal oxide coating of water insoluble ingredients	⤷ Try a Trial
European Patent Office	2431089	Revêtement d'oxyde métallique d'ingrédients insolubles dans l'eau (Metal oxide coating of water insoluble ingredients)	⤷ Try a Trial
Eurasian Patent Organization	015815	ПОКРЫТИЕ ИЗ ОКСИДА МЕТАЛЛА ДЛЯ ВОДОНЕРАСТВОРИМЫХ ИНГРЕДИЕНТОВ (METAL OXIDE COATING OF WATER INSOLUBLE INGREDIENTS)	⤷ Try a Trial
Eurasian Patent Organization	200800512	ПОКРЫТИЕ ИЗ ОКСИДА МЕТАЛЛА ДЛЯ ВОДОНЕРАСТВОРИМЫХ ИНГРЕДИЕНТОВ	⤷ Try a Trial
China	101277757	Metal oxide coating of water insoluble ingredients	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for benzoyl peroxide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1458369	CA 2008 00029	Denmark	⤷ Try a Trial	PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
1667986	92172	Luxembourg	⤷ Try a Trial	PRODUCT 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)
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
1586316	122011100019	Germany	⤷ Try a Trial	PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
0186118	SPC/GB05/029	United Kingdom	⤷ Try a Trial	PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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