GALDERMA LABS Company Profile

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GALDERMA LABS has twenty-eight approved drugs.

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

There are four hundred and twenty-seven patent family members on GALDERMA LABS drugs in thirty-seven countries and one hundred and seventy-nine 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	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	AB	RX	Yes	Yes	7,737,181	⤷ Subscribe	Y			⤷ Subscribe
Galderma Labs Lp	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		RX	Yes	Yes	10,933,046	⤷ Subscribe	Y			⤷ Subscribe
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	AB	RX	Yes	Yes	8,426,410	⤷ Subscribe				⤷ Subscribe
Galderma Labs Lp	AKLIEF	trifarotene	CREAM;TOPICAL	211527-001	Oct 4, 2019		RX	Yes	Yes	9,084,778	⤷ Subscribe	Y			⤷ Subscribe
>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	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	8,859,551	⤷ Subscribe
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	4,717,720	⤷ Subscribe
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	10,058,564	⤷ Subscribe
Galderma Labs Lp	DIFFERIN	adapalene	CREAM;TOPICAL	020748-001	May 26, 2000	4,717,720	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454511	SPC/GB99/008	United Kingdom	⤷ Subscribe	PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
2441753	SPC/GB17/036	United Kingdom	⤷ Subscribe	PRODUCT NAME: ALECTINIB (9-ETHYL-6,6-DIMETHYL-8-(4-MORPHOLIN-4-YL-PIPERIDIN-1-YL)-11-OXO-6,11-DIHYDRO-5H-BENZO(B)CARBAZOLE-3-CARBONITRILE) OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/16/1169 (NI) 20170220; UK PLGB 00031/0843 20170220
3170818	122020000044	Germany	⤷ Subscribe	PRODUCT NAME: KOMBINATION AUS (A) 3-(6-(1-(2,2-DIFLUORBENZO(D)(1,3)DIOXOL-5-YL)CYCLOPROPAN-CARBOXAMIDO)-3-METHYLPYRIDIN-2-YL)BENZOESAEURE UND (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1059 20151119
1131065	CA 2014 00036	Denmark	⤷ Subscribe	PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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