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 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

See drug sales revenues for benzoyl peroxide

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
St. Louis University	Phase 4
Next Science LLC	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
Taro	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	208776-001	May 25, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Galderma Labs Lp	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bausch	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes	⤷ 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)	2020170033		⤷ Sign Up
Japan	2009503056		⤷ Sign Up
Japan	5164840		⤷ 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
1458369	CA 2008 00029	Denmark	⤷ Sign Up	PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
1586316	122011100019	Germany	⤷ Sign Up	PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
0137963	97C0042	Belgium	⤷ Sign Up	PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
>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.