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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 Sol-gel Technologies and is included in one NDA. There are two patents protecting this drug.

This drug has thirty-one 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. 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:	31
US Patents:	2
Applicants:	1
NDAs:	1
Formulation / Manufacturing:	see details
DailyMed Link:	TWYNEO at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for TWYNEO

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.

Anatomical Therapeutic Chemical (ATC) Classes for TWYNEO

D10AD	Retinoids for topical use in acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

D10AE	Peroxides
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

L01XF	Retinoids for cancer treatment
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for TWYNEO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sol-gel Technologies	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes			Y
Sol-gel Technologies	TWYNEO	benzoyl peroxide; tretinoin	CREAM;TOPICAL	214902-001	Jul 26, 2021		RX	Yes	Yes			Y

International Patents for TWYNEO

Country	Patent Number	Estimated Expiration
South Korea	20130008002
World Intellectual Property Organization (WIPO)	2007015243
Israel	218255
Japan	5164840
Australia	2010337830
Canada	2773544

Supplementary Protection Certificates for TWYNEO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0137963	97C0042	Belgium		PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
1458369	122008000041	Germany		PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1458369	CA 2008 00029	Denmark		PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
1586316	SPC/GB11/054	United Kingdom		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
0526708	C300097	Netherlands		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
0591275	SPC/GB05/030	United Kingdom		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