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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 seven patents protecting this drug.

This drug has sixty-three 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:	63
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TWYNEO

Generic Entry Date for TWYNEO^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 214902 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 seven 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

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TOPICAL TREATMENT OF ACNE

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

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Glossary

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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				⤷ 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	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.

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Country	Patent Number	Title	Estimated Expiration
China	107625743	稳定化的包含核‑壳微囊的局部制剂 (Stabilized topical formulations containing core-shell microcapsules)	⤷ Sign Up
Mexico	2009008250	COMPOSICIONES PARA APLICACION TOPICA QUE COMPRENDEN UN PEROXIDO Y RETINOIDE. (COMPOSITIONS FOR TOPICAL APPLICATION COMPRISING A PEROXIDE AND RETINOID.)	⤷ Sign Up
Eurasian Patent Organization	200970724	КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ ПЕРОКСИД И РЕТИНОИД	⤷ Sign Up
South Korea	20130008002		⤷ Sign Up
South Korea	20090125243	COMPOSITIONS FOR TOPICAL APPLICATION COMPRISING A PEROXIDE AND RETINOID	⤷ Sign Up
Mexico	363379	FORMULACIONES TÓPICAS ESTABILIZADAS QUE CONTIENEN MICROCÁPSULAS DE NÚCLEO-CUBIERTA. (STABILIZED TOPICAL FORMULATIONS CONTAINING CORE-SHELL MICROCAPSULES.)	⤷ Sign Up
Israel	189159	חיפוי של מתכת אוקסיד למרכיבים בלתי מסיסים במים (Metal oxide coating of water insoluble ingredients)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TWYNEO

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1667986	92172	Luxembourg	⤷ Sign Up	PRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)
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
0526708	C300097	Netherlands	⤷ Sign Up	PRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228
0137963	97C0042	Belgium	⤷ Sign Up	PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description