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