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Last Updated: May 2, 2024

Benzoyl peroxide; tretinoin - Generic Drug Details

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What are the generic drug sources for benzoyl peroxide; tretinoin and what is the scope of freedom to operate?

Benzoyl peroxide; tretinoin is the generic ingredient in one branded drug marketed by Galderma Labs Lp and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Benzoyl peroxide; tretinoin has forty-seven patent family members in thirteen countries.

One supplier is listed for this compound.

Summary for benzoyl peroxide; tretinoin

International Patents:	47
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	9
DailyMed Link:	benzoyl peroxide; tretinoin at DailyMed

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

Generic Entry Date for benzoyl peroxide; tretinoin^: ⤷ 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; tretinoin

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

Sponsor	Phase
GWT-TUD GmbH	Phase 4
Galderma Laboratories, L.P.	Phase 4
Zeichner, Joshua, M.D.	Phase 4

See all benzoyl peroxide; tretinoin clinical trials

Pharmacology for benzoyl peroxide; tretinoin

Drug Class	Retinoid

Anatomical Therapeutic Chemical (ATC) Classes for benzoyl peroxide; tretinoin

US Patents and Regulatory Information for benzoyl peroxide; tretinoin

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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	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Galderma Labs Lp	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Galderma Labs Lp	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ 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; tretinoin

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008093346		⤷ Try a Trial
China	110891561	治疗痤疮的方法和组合物 (METHODS AND COMPOSITIONS FOR THE TREATMENT OF ACNE)	⤷ Try a Trial
South Korea	20130008002	CORE STABILIZED MICROCAPSULES, METHOD OF THEIR PREPARATION AND USES THEREOF	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for benzoyl peroxide; tretinoin

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122011100019	Germany	⤷ Try a Trial	PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
>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.