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Last Updated: February 29, 2020

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TRI-LUMA Drug Profile


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Which patents cover Tri-luma, and what generic alternatives are available?

Tri-luma is a drug marketed by Galderma Labs Lp and is included in one NDA. There are four patents protecting this drug.

This drug has twenty-nine patent family members in eighteen countries.

The generic ingredient in TRI-LUMA is fluocinolone acetonide; hydroquinone; tretinoin. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluocinolone acetonide; hydroquinone; tretinoin profile page.

US ANDA Litigation and Generic Entry Outlook for Tri-luma

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 25, 2022. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for TRI-LUMA
Drug patent expirations by year for TRI-LUMA
Drug Prices for TRI-LUMA

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Generic Entry Opportunity Date for TRI-LUMA
Generic Entry Date for TRI-LUMA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for TRI-LUMA

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 TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 RX Yes Yes   Start Trial   Start Trial 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 TRI-LUMA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2233112 132014902285293 Italy   Start Trial PRODUCT NAME: FLUOCINOLONE ACETONIDE(ILUVIEN); AUTHORISATION NUMBER(S) AND DATE(S): 042616019, 20140530;PL27813/0001, 20120504
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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