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Last Updated: March 24, 2023

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
What excipients (inactive ingredients) are in TWYNEO?TWYNEO excipients list
DailyMed Link:TWYNEO at DailyMed
Drug patent expirations by year for TWYNEO
DrugPatentWatch® Estimated Generic Entry Opportunity 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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions for topical application comprising a peroxide and retinoid
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Metal oxide coating of water insoluble ingredients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Galderma Labs Lp TWYNEO benzoyl peroxide; tretinoin CREAM;TOPICAL 214902-001 Jul 26, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Galderma Labs Lp TWYNEO benzoyl peroxide; tretinoin CREAM;TOPICAL 214902-001 Jul 26, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galderma Labs Lp TWYNEO benzoyl peroxide; tretinoin CREAM;TOPICAL 214902-001 Jul 26, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: See Plans and Pricing

Brazil

Patent: 2012012023
Estimated Expiration: See Plans and Pricing

Canada

Patent: 73544
Estimated Expiration: See Plans and Pricing

China

Patent: 2596186
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1200347
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 67132
Estimated Expiration: See Plans and Pricing

Japan

Patent: 34107
Estimated Expiration: See Plans and Pricing

Patent: 13516404
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 4128
Estimated Expiration: See Plans and Pricing

Patent: 12006636
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1203582
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 130008002
Estimated Expiration: See Plans and Pricing

Spain

Patent: 11499
Estimated Expiration: See Plans and Pricing

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
Japan 5923065 See Plans and Pricing
Brazil PI0614143 processo para revestir um material particulado insolével em Água, sàlido, com um àxido metÁlico, material particulado revestido, composiÇço, mÉtodo para o tratamento de uma condiÇço superficial em um induvÍduo, e, uso de material particulado revestido See Plans and Pricing
World Intellectual Property Organization (WIPO) 2019012536 See Plans and Pricing
Japan 5164840 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TWYNEO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0137963 97C0042 Belgium See Plans and Pricing PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
1458369 SPC/GB10/005 United Kingdom See Plans and Pricing PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1458369 122008000041 Germany See Plans and Pricing PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
0186118 SPC/GB05/029 United Kingdom See Plans and Pricing PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Harvard Business School
Baxter
Johnson and Johnson
Express Scripts

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.