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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-eight 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.

Summary for TRI-LUMA

International Patents:	28
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	37
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TRI-LUMA
DailyMed Link:	TRI-LUMA at DailyMed

Generic Entry Opportunity Date for TRI-LUMA

NDA:

021112

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.

Pharmacology for TRI-LUMA

Drug Class	Corticosteroid Melanin Synthesis Inhibitor Retinoid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists Melanin Synthesis Inhibitors
Physiological Effect	Depigmenting Activity

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

International Patents for TRI-LUMA

Country	Document Number	Estimated Expiration
Spain	2565317
Canada	2503539
European Patent Office	1562531