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	DIFFERIN	adapalene	CREAM;TOPICAL	020748-001	May 26, 2000	AB	RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	AB	RX	Yes	Yes	9,861,631	⤷ Sign Up				⤷ Sign Up
Galderma Labs Lp	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		RX	Yes	Yes	10,945,987	⤷ Sign Up				⤷ Sign Up
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	AB	RX	Yes	Yes	8,426,410	⤷ 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
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	8,080,530	⤷ 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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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1831149	C01831149/01	Switzerland	⤷ Sign Up	PRODUCT NAME: TRIFAROTEN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67632 17.12.2020
1831149	C 2022 002	Romania	⤷ Sign Up	PRODUCT NAME: TRIFAROTEN, OPTIONAL SUB FORMA UNEI SARI ACCEPTABILE DIN PUNCT DE VEDERE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: 14177/2021//01-02-03-04; DATE OF NATIONAL AUTHORISATION: 20211124; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): UK. PL 10590/0071; DATE OF FIRST AUTHORISATION IN EEA: 20200113
1831149	2090021-3	Sweden	⤷ Sign Up	PRODUCT NAME: TRIFAROTENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT. REG. NO/DATE: MT NR:58467 20200131; FIRST REG.: GB PL 10590/0071 20200113
2435024	2190014-7	Sweden	⤷ Sign Up	PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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