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Last Updated: November 4, 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 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

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 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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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.