Trifarotene - Generic Drug Details

What are the generic drug sources for trifarotene and what is the scope of patent protection?

Trifarotene is the generic ingredient in one branded drug marketed by Galderma Labs Lp and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Trifarotene has sixty patent family members in twenty-eight countries.

There is one drug master file entry for trifarotene. One supplier is listed for this compound.

Summary for trifarotene

International Patents:	60
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	9
Patent Applications:	89
What excipients (inactive ingredients) are in trifarotene?	trifarotene excipients list
DailyMed Link:	trifarotene at DailyMed

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

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.

Recent Clinical Trials for trifarotene

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Teva Pharmaceuticals USA	Phase 3
Teva Pharmaceuticals, Inc.	Phase 3
Galderma R&D	Phase 4

See all trifarotene clinical trials

Pharmacology for trifarotene

Drug Class

Retinoid

Paragraph IV (Patent) Challenges for TRIFAROTENE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AKLIEF	Cream	trifarotene	0.005%	211527	2	2023-10-04

US Patents and Regulatory Information for trifarotene

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	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes			Y	Y
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes			Y
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes			Y

International Patents for trifarotene

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2014152998	СОДЕРЖАЩИЕ РЕТИНОИД КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ ТИПА ЭМУЛЬСИИ "МАСЛО В ВОДЕ"
Chile	2014003226	Composiciones tópicas tipo emulsion aceite en agua, tal que la fase grasa comprende un retinoide, un solvente principal y un cosolvente, y la fase acuosa un agente gelificante; y su uso en el tratamiento de afecciones a la piel como acné común, rosácea, ictiosis, psoriasis, entre otras.
South Africa	201408744	OIL/WATER-EMULSION-TYPE TOPICAL COMPOSITIONS CONTAINING A RETINOID
South Korea	102127022
Portugal	1831149
France	2991177	COMPOSITIONS TOPIQUES, CONTENANT UN RETINOIDE, DE TYPE EMULSION HUILE DANS EAU SANS EMULSIONNANT
Japan	6271527

Supplementary Protection Certificates for trifarotene

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1831149	C01831149/01	Switzerland		PRODUCT NAME: TRIFAROTEN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67632 17.12.2020
1831149	719	Finland
1831149	2020/023	Ireland		PRODUCT NAME: TRIFAROTENE, OPTIONALLY IN THE FORM OF APHARMACEUTICALLY ACCEPTABLE SALT; NAT REGISTRATION NO/DATE: PA0590/031/001 20200221; FIRST REGISTRATION NO/DATE: PL 10590/0071-0001 13/01/2020
1831149	PA2022002,C1831149	Lithuania		PRODUCT NAME: TRIFAROTENAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS ; REGISTRATION NO/DATE: UK, PL 10590/0071 20200113
1831149	C202030025	Spain		PRODUCT NAME: TRIFAROTENO, OPCIONALMENT EN FORMA DE UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: 85017-SE/H/1863/001/DC; DATE OF AUTHORISATION: 20200417; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): PL 10590/0071 -0001; DATE OF FIRST AUTHORISATION IN EEA: 20200113
1831149	20C1025	France		PRODUCT NAME: TRIFAROTENE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; NAT. REGISTRATION NO/DATE: CIS 6 363 190 8 20200217; FIRST REGISTRATION: GB - PL 10590/0071 20200113
1831149	301042	Netherlands		PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATIONAL REGISTRATION NO/DATE: RVG 124058 20200310; FIRST REGISTRATION: GB PL 10590/0071 20200113