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 fifty-nine 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:	59
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	8
Patent Applications:	76
What excipients (inactive ingredients) are in trifarotene?	trifarotene excipients list
DailyMed Link:	trifarotene at DailyMed

Recent Clinical Trials for trifarotene

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

Sponsor	Phase
Galderma R&D	Phase 4
Mayne Pharma International Pty Ltd	Phase 2
Galderma R&D	Phase 3

See all trifarotene clinical trials

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

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	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y			See Plans and Pricing
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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
Austria	542791		See Plans and Pricing
China	104507471	Topical compositions in the form of a gel containing a particular solubilised retinoid	See Plans and Pricing
South Africa	200705930	Novel ligands that modulate rar receptors, and use thereof in human medicine and in cosmetics	See Plans and Pricing
Lithuania	PA2022002		See Plans and Pricing
Canada	2874270	COMPOSITIONS TOPIQUES SOUS FORME DE GEL CONTENANT UN RETINOIDE PARTICULIER SOLUBILISE (TOPICAL COMPOSITIONS IN THE FORM OF A GEL CONTAINING A PARTICULAR SOLUBILISED RETINOID)	See Plans and Pricing
>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	CA 2020 00027	Denmark	See Plans and Pricing	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	PA2022002	Lithuania	See Plans and Pricing	PRODUCT NAME: TRIFAROTENAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOS ; REGISTRATION NO/DATE: PL 10590/0071 20200113
1831149	2020C/525	Belgium	See Plans and Pricing	PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: BE554133 20200224
1831149	2020/023	Ireland	See Plans and Pricing	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	20C1025	France	See Plans and Pricing	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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