twyneo Drug Patent Profile
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When do Twyneo patents expire, and when can generic versions of Twyneo launch?
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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Questions you can ask:
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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 |
![twyneo drug patent expirations Drug patent expirations by year for twyneo](/p/graph/s/t/twyneo-patent-expirations.png)
![Drug Prices for twyneo](/p/graph/drug-price/twyneo.png)
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 Class | Retinoid |
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 | |||
>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
Patent: Core stabilized microcapsules, method of their preparation and uses thereof
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2012012023
Patent: processo para preparar microcápsulas, microcápsulas, composição, método para tratar uma condição superficial em um indivíduo, e, uso das microcápsulas
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 73544
Patent: MICROCAPSULES A NOYAU STABILISE, PROCEDE DE LEUR PREPARATION ET UTILISATIONS DE CELLES-CI (CORE STABILIZED MICROCAPSULES, METHOD OF THEIR PREPARATION AND USES THEREOF)
Estimated Expiration: ⤷ Sign Up
China
Patent: 2596186
Patent: Core stabilized microcapsules, method of their preparation and uses thereof
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 1200347
Patent: МИКРОКАПСУЛЫ СО СТАБИЛИЗИРОВАННЫМ ЯДРОМ, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 67132
Patent: MICROCAPSULES À NOYAU STABILISÉ, PROCÉDÉ DE LEUR PRÉPARATION ET UTILISATIONS DE CELLES-CI (CORE STABILIZED MICROCAPSULES, METHOD OF THEIR PREPARATION AND USES THEREOF)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 34107
Estimated Expiration: ⤷ Sign Up
Patent: 13516404
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 4128
Patent: MICROCAPSULAS ESTABILIZADAS CON NUCLEO, METODO PARA SU PREPARACION Y USOS DE LAS MISMAS. (CORE STABILIZED MICROCAPSULES, METHOD OF THEIR PREPARATION AND USES THEREOF.)
Estimated Expiration: ⤷ Sign Up
Patent: 12006636
Patent: MICROCAPSULAS ESTABILIZADAS CON NUCLEO, METODO PARA SU PREPARACION Y USOS DE LAS MISMA. (CORE STABILIZED MICROCAPSULES, METHOD OF THEIR PREPARATION AND USES THEREOF.)
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1203582
Patent: CORE STABILIZED MICROCAPSULES, METHOD OF THEIR PREPARATION AND USES THEREOF
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 130008002
Patent: CORE STABILIZED MICROCAPSULES, METHOD OF THEIR PREPARATION AND USES THEREOF
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 |
---|---|---|---|
China | 102596186 | Core stabilized microcapsules, method of their preparation and uses thereof | ⤷ Sign Up |
Japan | 5164840 | ⤷ Sign Up | |
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 | ⤷ Sign Up |
Japan | 2013516404 | ⤷ Sign Up | |
>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 | ⤷ Sign Up | PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121 |
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 |
1458369 | SPC/GB10/005 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |