BENZOYL PEROXIDE; TRETINOIN - Generic Drug Details

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

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

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

US Patents and Regulatory Information for BENZOYL PEROXIDE; TRETINOIN

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

International Patents for BENZOYL PEROXIDE; TRETINOIN

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0614143	processo para revestir um material particulado insolével em Água, sàlido, com um àxido metÁlico, material particulado revestido, composiÇço, mÉtodo para o tratamento de uma condiÇço superficial em um induvÍduo, e, uso de material particulado revestido
Canada	2677184	COMPOSITIONS D'APPLICATION TOPIQUE COMPRENANT UN PEROXYDE ETUN RETINOIDE (COMPOSITIONS FOR TOPICAL APPLICATION COMPRISING A PEROXIDE AND RETINOID)
Eurasian Patent Organization	200800512	ПОКРЫТИЕ ИЗ ОКСИДА МЕТАЛЛА ДЛЯ ВОДОНЕРАСТВОРИМЫХ ИНГРЕДИЕНТОВ
South Korea	101158162
South Africa	200801146	Metal oxide coating of water insoluble ingredients

Supplementary Protection Certificates for BENZOYL PEROXIDE; TRETINOIN

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