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 |
Anatomical Therapeutic Chemical (ATC) Classes for trifarotene
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 | 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
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
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 |