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Last Updated: May 28, 2024

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TWYNEO Drug Patent Profile


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Which patents cover Twyneo, and what generic alternatives are available?

Twyneo is a drug marketed by Galderma Labs Lp and is included in one NDA. There are five patents protecting this drug.

This drug has forty-seven patent family members in thirteen countries.

The generic ingredient in TWYNEO is benzoyl peroxide; tretinoin. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the benzoyl peroxide; tretinoin profile page.

DrugPatentWatch® Generic Entry Outlook for Twyneo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 30, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for TWYNEO
International Patents:47
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Formulation / Manufacturing:see details
Drug Prices: Drug price information for TWYNEO
What excipients (inactive ingredients) are in TWYNEO?TWYNEO excipients list
DailyMed Link:TWYNEO at DailyMed
Drug patent expirations by year for TWYNEO
Drug Prices for TWYNEO

See drug prices for TWYNEO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TWYNEO
Generic Entry Date for TWYNEO*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Pharmacology for TWYNEO
Drug ClassRetinoid

US Patents and Regulatory Information for TWYNEO

TWYNEO is protected by five US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TWYNEO is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TWYNEO

Methods and compositions for the treatment of acne
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

Core stabilized microcapsules, method of their preparation and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

Core stabilized microcapsules, method of their preparation and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions for topical application comprising a peroxide and retinoid
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Metal oxide coating of water insoluble ingredients
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN ADULTS AND PEDIATRIC PATIENTS 9 YEARS OF AGE AND OLDER

FDA Regulatory Exclusivity protecting TWYNEO

NEW COMBINATION
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  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
>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 TWYNEO

When does loss-of-exclusivity occur for TWYNEO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 10337830
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2012012023
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 73544
Estimated Expiration: ⤷  Sign Up

China

Patent: 2596186
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 1200347
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 67132
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 34107
Estimated Expiration: ⤷  Sign Up

Patent: 13516404
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 4128
Estimated Expiration: ⤷  Sign Up

Patent: 12006636
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1203582
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 130008002
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 11499
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TWYNEO around the world.

Country Patent Number Title Estimated Expiration
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
Brazil 112012012023 processo para preparar microcápsulas, microcápsulas, composição, método para tratar uma condição superficial em um indivíduo, e, uso das microcápsulas ⤷  Sign Up
China 101277757 Metal oxide coating of water insoluble ingredients ⤷  Sign Up
China 110891561 治疗痤疮的方法和组合物 (METHODS AND COMPOSITIONS FOR THE TREATMENT OF ACNE) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2011080741 ⤷  Sign Up
Canada 3069287 METHODES ET COMPOSITIONS POUR LE TRAITEMENT DE L'ACNEE (METHODS AND COMPOSITIONS FOR THE TREATMENT OF ACNE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TWYNEO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1458369 122008000041 Germany ⤷  Sign Up PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1458369 C01458369/01 Switzerland ⤷  Sign Up PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
1458369 CA 2008 00029 Denmark ⤷  Sign Up PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
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
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
1586316 SPC/GB11/054 United Kingdom ⤷  Sign Up PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523
>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.