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Last Updated: May 8, 2021

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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 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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for trifarotene
International Patents:46
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 16
Clinical Trials: 3
Patent Applications: 36
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
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   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Galderma Labs Lp AKLIEF trifarotene CREAM;TOPICAL 211527-001 Oct 4, 2019 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Galderma Labs Lp AKLIEF trifarotene CREAM;TOPICAL 211527-001 Oct 4, 2019 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
>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 132020000000088 Italy   Get Started for $10 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
1831149 2090021-3 Sweden   Get Started for $10 PRODUCT NAME: TRIFAROTENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT. REG. NO/DATE: MT NR:58467 20200131; FIRST REG.: GB PL 10590/0071 20200113
1831149 LUC00162 Luxembourg   Get Started for $10 PRODUCT NAME: TRIFAROTENE, EVENTUELLEMENT SOUS LA FORME DE SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
Baxter
Medtronic
Johnson and Johnson
Colorcon

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