BENZOYL PEROXIDE - Generic Drug Details

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What are the generic 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 Speclt, Mylan Pharms Inc, Padagis Israel, Taro, Zydus Pharms, Stiefel, Biofrontera, Valeant Intl, and Rising, and is included in twenty-five NDAs. There are twenty-five 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 is one tentative approval for this compound.

Summary for BENZOYL PEROXIDE

International Patents:	28
US Patents:	25
Tradenames:	10
Applicants:	14
NDAs:	25
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	109
Patent Applications:	5,591
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

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BENZOYL PEROXIDE

Generic Entry Date for BENZOYL PEROXIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Chang Gung Memorial Hospital	Phase 1/Phase 2
Next Science LLC	Phase 4
St. Louis University	Phase 4

See all BENZOYL PEROXIDE clinical trials

Generic filers with tentative approvals for BENZOYL PEROXIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	3.75%; EQ 1.2% BASE	GEL;TOPICAL

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
Galderma Labs Lp	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biofrontera	AKTIPAK	benzoyl peroxide; erythromycin	GEL;TOPICAL	050769-001	Nov 27, 2000		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	208683-001	Jun 5, 2018	AB	RX	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

International Patents for BENZOYL PEROXIDE

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2020170031		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2020170029		⤷ Sign Up
South Korea	101158162		⤷ Sign Up
>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
0526708	C300097	Netherlands	⤷ Sign Up	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
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
1458369	CA 2008 00029	Denmark	⤷ Sign Up	PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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