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:	10
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
Taro Pharmaceuticals USA	Phase 1
Teva Pharmaceuticals, Inc.	Phase 3
Teva Pharmaceuticals USA	Phase 3

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
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	Y

International Patents for TRIFAROTENE

Country	Patent Number	Title	Estimated Expiration
South Korea	102127022
China	101087752	Novel ligands that modulate RAR receptors, and use thereof in human medicine and in cosmetics
Russian Federation	2014152977	КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ В ФОРМЕ ГЕЛЯ, СОДЕРЖАЩИЕ ОСОБЫЙ СОЛЮБИЛИЗИРОВАННЫЙ РЕТИНОИД
New Zealand	702472	Oil/water-emulsion-type topical compositions containing a retinoid
Japan	6271527
Canada	2590246	NOUVEAUX LIGANDS QUI MODULENT LES RECEPTEURS RAR, ET LEUR UTILISATION EN MEDECINE ET EN COSMETIQUE (NOVEL LIGANDS THAT MODULATE RAR RECEPTORS, AND USE THEREOF IN HUMAN MEDICINE AND IN COSMETICS)
Austria	E542791

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	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	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	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	CA 2020 00027	Denmark		PRODUCT NAME: TRIFAROTEN, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: 61878 20200120; FIRST REG. NO/DATE: UK PL 10590/0071 20200113
1831149	122020000029	Germany		PRODUCT NAME: TRIFAROTEN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE VON TRIFAROTEN; NAT. REGISTRATION NO/DATE: 2203224.00.00 20200415; FIRST REGISTRATION: GB PL 10590/0071 - 0001 20200113
1831149	C 2022 002	Romania		PRODUCT NAME: TRIFAROTEN, OPTIONAL SUB FORMA UNEI SARI ACCEPTABILE DIN PUNCT DE VEDERE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: 14177/2021//01-02-03-04; DATE OF NATIONAL AUTHORISATION: 20211124; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): UK. PL 10590/0071; DATE OF FIRST AUTHORISATION IN EEA: 20200113