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Last Updated: November 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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Benzoyl peroxide; tretinoin has sixty-three patent family members in thirteen countries.

One supplier is listed for this compound.

Summary for benzoyl peroxide; tretinoin
International Patents:63
US Patents:6
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*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
GWT-TUD GmbHPhase 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 ClassRetinoid

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

Country Patent Number Title Estimated Expiration
Japan 5923065 ⤷  Sign Up
European Patent Office 2467132 MICROCAPSULES À NOYAU STABILISÉ, PROCÉDÉ DE LEUR PRÉPARATION ET UTILISATIONS DE CELLES-CI (CORE STABILIZED MICROCAPSULES, METHOD OF THEIR PREPARATION AND USES THEREOF) ⤷  Sign Up
Mexico 344128 MICROCAPSULAS ESTABILIZADAS CON NUCLEO, METODO PARA SU PREPARACION Y USOS DE LAS MISMAS. (CORE STABILIZED MICROCAPSULES, METHOD OF THEIR PREPARATION AND USES THEREOF.) ⤷  Sign Up
South Korea 20140043397 STABILIZED TOPICAL FORMULATIONS CONTAINING CORE-SHELL MICROCAPSULES ⤷  Sign Up
Eurasian Patent Organization 200970724 КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ ПЕРОКСИД И РЕТИНОИД ⤷  Sign Up
South Korea 20080039927 METAL OXIDE COATING OF WATER INSOLUBLE INGREDIENTS ⤷  Sign Up
South Africa 201203582 CORE STABILIZED MICROCAPSULES, METHOD OF THEIR PREPARATION AND USES THEREOF ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for benzoyl peroxide; tretinoin

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
1586316 122011100019 Germany ⤷  Sign Up PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
0186118 SPC/GB05/029 United Kingdom ⤷  Sign Up PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
1458369 SPC/GB10/005 United Kingdom ⤷  Sign Up PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1667986 92172 Luxembourg ⤷  Sign Up 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)
0137963 97C0042 Belgium ⤷  Sign Up PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
1458369 C01458369/01 Switzerland ⤷  Sign Up PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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