Trifarotene - Generic Drug Details
✉ Email this page to a colleague
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*:
Constraining patent/regulatory exclusivity:
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 |
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 | ⤷ 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 | 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 | ||||
| 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 | ⤷ 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
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 2007007696 | COMPUESTOS LIGANDOS MODULADORES DE LOS RECEPTORES NUCLEARES DEL ACIDO RETINOICO(RARS) Y USO EN MEDICINA HUMANA Y EN COSMETICOS. (NOVEL LIGANDS THAT MODULATE RAR RECEPTORS, AND USE THEREOF IN HUMAN MEDICINE AND IN COSMETICS.) | ⤷ Try a Trial |
| China | 104507469 | Oil/water-emulsion-type topical compositions containing a retinoid | ⤷ Try a Trial |
| France | 2991177 | COMPOSITIONS TOPIQUES, CONTENANT UN RETINOIDE, DE TYPE EMULSION HUILE DANS EAU SANS EMULSIONNANT | ⤷ Try a Trial |
| Chile | 2014003226 | Composiciones tópicas tipo emulsion aceite en agua, tal que la fase grasa comprende un retinoide, un solvente principal y un cosolvente, y la fase acuosa un agente gelificante; y su uso en el tratamiento de afecciones a la piel como acné común, rosácea, ictiosis, psoriasis, entre otras. | ⤷ Try a Trial |
| Russian Federation | 2637408 | СОДЕРЖАЩИЕ РЕТИНОИД КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ ТИПА ЭМУЛЬСИИ "МАСЛО В ВОДЕ" (RETINOID-CONTAINING COMPOUNDS FOR LOCAL APPLICATION OF "OIL IN WATER" EMULSION TYPE) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for trifarotene
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | SPC/GB20/027 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: TRIFAROTENE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK PL 10590/0071 -0001 20200113 |
| 1831149 | 2020/023 | Ireland | ⤷ Try a Trial | 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 | 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 | 301042 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATIONAL REGISTRATION NO/DATE: RVG 124058 20200310; FIRST REGISTRATION: GB PL 10590/0071 20200113 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
