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
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 |

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 Class | Retinoid |
Anatomical Therapeutic Chemical (ATC) Classes for TWYNEO
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 |