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Last Updated: June 28, 2022

TRI-LUMA Drug Patent Profile


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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

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

See drug prices for TRI-LUMA

DrugPatentWatch® Estimated 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

TRI-LUMA is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRI-LUMA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Topical skin care composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Topical skin care composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Topical skin care composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Topical skin care composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 03284353
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 14882
Estimated Expiration: See Plans and Pricing

Patent: 0314882
Estimated Expiration: See Plans and Pricing

Canada

Patent: 03539
Estimated Expiration: See Plans and Pricing

China

Patent: 38587
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17292
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 62531
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 62531
Estimated Expiration: See Plans and Pricing

Patent: 02004
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 88831
Estimated Expiration: See Plans and Pricing

Patent: 23040
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 28549
Estimated Expiration: See Plans and Pricing

Japan

Patent: 38234
Estimated Expiration: See Plans and Pricing

Patent: 28973
Estimated Expiration: See Plans and Pricing

Patent: 06507285
Estimated Expiration: See Plans and Pricing

Patent: 10280738
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05004404
Estimated Expiration: See Plans and Pricing

Poland

Patent: 9020
Estimated Expiration: See Plans and Pricing

Patent: 6715
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 62531
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 50313
Estimated Expiration: See Plans and Pricing

Patent: 05115856
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 62531
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 0851789
Estimated Expiration: See Plans and Pricing

Patent: 0852367
Estimated Expiration: See Plans and Pricing

Patent: 050083828
Estimated Expiration: See Plans and Pricing

Patent: 060040755
Estimated Expiration: See Plans and Pricing

Spain

Patent: 65317
Estimated Expiration: See Plans and Pricing

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

Supplementary Protection Certificates for TRI-LUMA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2233112 132014902285293 Italy See Plans and Pricing 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
AstraZeneca
Boehringer Ingelheim
McKinsey
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.