GALDERMA LABS LP Company Profile

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GALDERMA LABS LP has twenty-six approved drugs.

There are fifty-eight US patents protecting GALDERMA LABS LP drugs.

There are four hundred and five patent family members on GALDERMA LABS LP drugs in thirty-seven countries and one hundred and seventy-eight supplementary protection certificates in eighteen countries.

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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	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	AB	RX	Yes	Yes	8,859,551	⤷ Sign Up				⤷ Sign Up
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	9,498,465	⤷ Sign Up	Y			⤷ Sign Up
Galderma Labs Lp	VECTICAL	calcitriol	OINTMENT;TOPICAL	022087-001	Jan 23, 2009		RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	EPIDUO	adapalene; benzoyl peroxide	GEL;TOPICAL	022320-001	Dec 8, 2008	8,809,305	⤷ Sign Up
Galderma Labs Lp	DIFFERIN	adapalene	CREAM;TOPICAL	020748-001	May 26, 2000	4,717,720	⤷ Sign Up
Galderma Labs Lp	TRI-LUMA	fluocinolone acetonide; hydroquinone; tretinoin	CREAM;TOPICAL	021112-001	Jan 18, 2002	7,939,516	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Topical Gel	0.30%	➤ Subscribe	2009-09-15
➤ Subscribe	Gel	0.1%/2.5%	➤ Subscribe	2011-12-30
➤ Subscribe	Topical Gel	0.33%	➤ Subscribe	2014-12-15
➤ Subscribe	Spray	0.05%	➤ Subscribe	2008-09-29
➤ Subscribe	Delayed-release Capsules	40 mg	➤ Subscribe	2008-12-11
➤ Subscribe	Cream	1%	➤ Subscribe	2016-12-30
➤ Subscribe	Topical Gel	1%	➤ Subscribe	2008-10-21
➤ Subscribe	Lotion	0.05%	➤ Subscribe	2006-03-27
➤ Subscribe	Topical Shampoo	0.05%	➤ Subscribe	2008-01-09

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004093886	⤷ Sign Up
Japan	2009542779	⤷ Sign Up
China	105828825	⤷ Sign Up
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1620113	CA 2015 00045	Denmark	⤷ Sign Up	PRODUCT NAME: IVERMECTIN, 22, 23-DIHYDROAVERMECTINB1A + 22,23-DIHRODROAVERMECTIN B1B FOR USE IN THE TREATMNET OF RESACEA; NAT. REG. NO/DATE: 54123 20150422; FIRST REG. NO/DATE: MT MA 117/01101 20150402
2826776	LUC00207	Luxembourg	⤷ Sign Up	PRODUCT NAME: A COMBINATION OF (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3-CARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1306 20181106
2435024	SPC/GB21/029	United Kingdom	⤷ Sign Up	PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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