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Last Updated: May 2, 2024

Trifarotene - Generic Drug Details

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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

Generic Entry Date for trifarotene^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

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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	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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 trifarotene

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006066978		⤷ Try a Trial
Canada	2874474	COMPOSITIONS TOPIQUES, CONTENANT UN RETINOIDE, DE TYPE EMULSION HUILE DANS EAU (OIL/WATER-EMULSION-TYPE TOPICAL COMPOSITIONS CONTAINING A RETINOID)	⤷ Try a Trial
Australia	2005318292	Novel ligands that modulate RAR receptors, and use thereof in human medicine and in cosmetics	⤷ Try a Trial
Israel	236001	תכשירים מסוג אמולסיית שמן/מים למתן מקומי הכוללים רטינואיד (Oil/water-emulsion-type topical compositions containing a retinoid)	⤷ Try a Trial
Japan	5258299		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for trifarotene

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1831149	122020000029	Germany	⤷ Try a Trial	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	C202030025	Spain	⤷ Try a Trial	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	PA2022002	Lithuania	⤷ Try a Trial	PRODUCT NAME: TRIFAROTENAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS ; REGISTRATION NO/DATE: PL 10590/0071 20200113
1831149	20C1025	France	⤷ Try a Trial	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	CA 2020 00027	Denmark	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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