TRI-LUMA Drug Patent Profile

Which patents cover Tri-luma, and when can generic versions of Tri-luma launch?

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.

DrugPatentWatch^® 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

Summary for TRI-LUMA

International Patents:	29
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	31
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TRI-LUMA
What excipients (inactive ingredients) are in TRI-LUMA?	TRI-LUMA excipients list
DailyMed Link:	TRI-LUMA at DailyMed

See drug prices for TRI-LUMA

DrugPatentWatch^® Estimated 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

Anatomical Therapeutic Chemical (ATC) Classes for TRI-LUMA

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D10AD	Retinoids for topical use in acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

L01XF	Retinoids for cancer treatment
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for TRI-LUMA

TRI-LUMA is protected by four US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting 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
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

When does loss-of-exclusivity occur for TRI-LUMA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Japan

Mexico

Poland

Portugal

Russian Federation

Slovenia

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRI-LUMA around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	1562531
Japan	4638234
South Korea	100851789
Hong Kong	1223040	局部皮膚護理組合物 (TOPICAL SKIN CARE COMPOSITION)
Canada	2503539	COMPOSITION DE SOIN POUR LA PEAU A APPLICATION TOPIQUE (TOPICAL SKIN CARE COMPOSITION)

Supplementary Protection Certificates for TRI-LUMA

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