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 seven 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: | 7 |
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 | 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 |
---|---|---|---|
Eurasian Patent Organization | 200800512 | ПОКРЫТИЕ ИЗ ОКСИДА МЕТАЛЛА ДЛЯ ВОДОНЕРАСТВОРИМЫХ ИНГРЕДИЕНТОВ | ⤷ Sign Up |
Canada | 2834681 | FORMULATIONS TOPIQUES STABILISEES CONTENANT DES MICROCAPSULES COEUR-ECORCE (STABILIZED TOPICAL FORMULATIONS CONTAINING CORE-SHELL MICROCAPSULES) | ⤷ Sign Up |
Japan | 2009503056 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2011080741 | ⤷ 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 |
---|---|---|---|---|
0137963 | 97C0042 | Belgium | ⤷ Sign Up | PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121 |
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 |
0591275 | SPC/GB05/030 | United Kingdom | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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