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Last Updated: June 30, 2022

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

SponsorPhase
Galderma R&DPhase 4
Mayne Pharma International Pty LtdPhase 2
Galderma R&DPhase 3

See all TRIFAROTENE clinical trials

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 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 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
>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.) See Plans and Pricing
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) See Plans and Pricing
Brazil PI0517500 compostos, uso de uma composição, composição farmacêutica, composição cosmética, uso não-terapêutico de uma composição cosmética e processo cosmético para melhorar a aparência da pele See Plans and Pricing
South Africa 201408744 OIL/WATER-EMULSION-TYPE TOPICAL COMPOSITIONS CONTAINING A RETINOID 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 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 C202030025 Spain See Plans and Pricing 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 See Plans and Pricing 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
1831149 122020000029 Germany See Plans and Pricing 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 132020000000088 Italy See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
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Express Scripts
Johnson and Johnson
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Harvard Business School

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