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Last Updated: September 25, 2020

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Trifarotene - Generic Drug Details

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What are the generic drug sources for trifarotene and what is the scope of patent protection?

Trifarotene is the generic ingredient in one branded drug marketed by Galderma Labs Lp and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Trifarotene has forty-five patent family members in twenty-five countries.

There is one drug master file entry for trifarotene. One supplier is listed for this compound.

Summary for trifarotene
International Patents:45
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Suppliers / Packagers: 1
Bulk Api Vendors: 9
Clinical Trials: 3
Patent Applications: 19
DailyMed Link:trifarotene at DailyMed
Recent Clinical Trials for trifarotene

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

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

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   Start Trial   Start Trial   Start Trial
Galderma Labs Lp AKLIEF trifarotene CREAM;TOPICAL 211527-001 Oct 4, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Galderma Labs Lp AKLIEF trifarotene CREAM;TOPICAL 211527-001 Oct 4, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Galderma Labs Lp AKLIEF trifarotene CREAM;TOPICAL 211527-001 Oct 4, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp AKLIEF trifarotene CREAM;TOPICAL 211527-001 Oct 4, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for trifarotene

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1831149 301042 Netherlands   Start 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
1831149 CA 2020 00027 Denmark   Start 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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Serving leading biopharmaceutical companies globally:

Dow
Baxter
Express Scripts
Harvard Business School
AstraZeneca
McKesson

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