Trifarotene - Generic Drug Details

What are the generic drug sources for trifarotene and what is the scope of freedom to operate?

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

Anatomical Therapeutic Chemical (ATC) Classes for trifarotene

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

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
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			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

International Patents for trifarotene

Country	Patent Number	Title	Estimated Expiration
Japan	2015518034	特定の可溶化レチノイドを含有するゲルの形態の局所組成物
Brazil	112014029879	composições tópicas em forma de gel que contêm um retinoide particular solubilizado
European Patent Office	2854802	COMPOSITIONS TOPIQUES, CONTENANT UN RÉTINOÏDE, DE TYPE ÉMULSION HUILE DANS EAU (TOPICAL OIL IN WATER EMULSION COMPOSITIONS COMPRISING A RETINOID)
Mexico	354540	COMPOSICIONES TOPICAS DE TIPO EMULSION ACEITE EN AGUA QUE CONTIENEN UN RETINOIDE. (OIL/WATER-EMULSION-TYPE TOPICAL COMPOSITIONS CONTAINING A RETINOID.)
France	2991176	COMPOSITIONS TOPIQUES, CONTENANT UN RETINOIDE SOLUBILISE, DE TYPE GEL HYDROGLYCOLIQUE
Mexico	2014014517	COMPOSICIONES TOPICAS BAJO LA FORMA DE UN GEL QUE CONTIENE UN RETINOIDE PARTICULAR SOLUBILIZADO. (TOPICAL COMPOSITIONS IN THE FORM OF A GEL CONTAINING A PARTICULAR SOLUBILISED RETINOID.)

Supplementary Protection Certificates for trifarotene

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	132020000000088	Italy		PRODUCT NAME: TRIFAROTENE, FACOLTATIVAMENTE NELLA FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE(SELGAMIS); AUTHORISATION NUMBER(S) AND DATE(S): PL 10590/0071 - 0001, 20200113;047209010-022-034-046, 20200520
1831149	LUC00162	Luxembourg		PRODUCT NAME: TRIFAROTENE, EVENTUELLEMENT SOUS LA FORME DE SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: PL 105590/0071 - 0001 20200519
1831149	719	Finland
1831149	C01831149/01	Switzerland		PRODUCT NAME: TRIFAROTEN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67632 17.12.2020
1831149	2020C/525	Belgium		PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: BE554133 20200224