GALDERMA LABS Company Profile

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GALDERMA LABS has twenty-eight approved drugs.

There are sixty-one US patents protecting GALDERMA LABS drugs.

There are four hundred and twenty-one patent family members on GALDERMA LABS 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	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes	7,550,440	⤷ Sign Up	Y			⤷ Sign Up
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	AB	RX	Yes	Yes	8,394,406	⤷ Sign Up	Y			⤷ Sign Up
Galderma Labs Lp	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		RX	Yes	Yes	11,877,997	⤷ 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	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005	7,348,317	⤷ Sign Up
Galderma Labs Lp	DIFFERIN	adapalene	CREAM;TOPICAL	020748-001	May 26, 2000	RE34440	⤷ Sign Up
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015	9,814,690	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Gel	0.3%/2.5%	➤ Subscribe	2016-05-04
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0579826	SPC/GB02/042	United Kingdom	⤷ Sign Up	PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422
1831149	LUC00162	Luxembourg	⤷ Sign Up	PRODUCT NAME: TRIFAROTENE, EVENTUELLEMENT SOUS LA FORME DE SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: PL 105590/0071 - 0001 20200519
1631293	C300683	Netherlands	⤷ Sign Up	PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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