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Galderma Labs Company Profile

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What is the competitive landscape for GALDERMA LABS, and when can generic versions of GALDERMA LABS drugs launch?

GALDERMA LABS has twenty-six approved drugs.

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

There are four hundred and thirty-six patent family members on GALDERMA LABS drugs in thirty-six countries and one hundred and thirty-two supplementary protection certificates in seventeen countries.

Summary for Galderma Labs

International Patents:	436
US Patents:	69
Tradenames:	17
Ingredients:	14
NDAs:	26

Drugs and US Patents for Galderma Labs

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	020380-002	Jul 8, 2016		OTC	Yes	Yes
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes	8,470,788		Y
Galderma Labs Lp	TRI-LUMA	fluocinolone acetonide; hydroquinone; tretinoin	CREAM;TOPICAL	021112-001	Jan 18, 2002		RX	Yes	Yes	8,653,053		Y
Galderma Labs	EPIDUO FORTE	adapalene; benzoyl peroxide	GEL;TOPICAL	207917-001	Jul 15, 2015		RX	Yes	Yes	9,814,690		Y
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005	AB	RX	Yes	Yes	7,348,317		Y
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes	8,080,530		Y
Galderma Labs Lp	SOOLANTRA	ivermectin	CREAM;TOPICAL	206255-001	Dec 19, 2014	AB	RX	Yes	Yes	9,233,118

Expired US Patents for Galderma Labs

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	CLOBEX	clobetasol propionate	SPRAY;TOPICAL	021835-001	Oct 27, 2005	5,990,100
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	8,066,976
Galderma Labs Lp	DIFFERIN	adapalene	CREAM;TOPICAL	020748-001	May 26, 2000	4,717,720
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	7,316,810
Galderma Labs Lp	METVIXIA	methyl aminolevulinate hydrochloride	CREAM;TOPICAL	021415-001	Jul 27, 2004	6,034,267
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	5,789,395
Galderma Labs Lp	DIFFERIN	adapalene	GEL;TOPICAL	021753-001	Jun 19, 2007	4,717,720

Paragraph IV (Patent) Challenges for GALDERMA LABS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Delayed-release Capsules	40 mg		2008-12-11
	Cream	1%		2016-12-30
	Topical Gel	1%		2008-10-21
	Lotion	0.05%		2006-03-27
	Topical Shampoo	0.05%		2008-01-09
	Topical Gel	0.30%		2009-09-15
	Gel	0.1%/2.5%		2011-12-30
	Topical Gel	0.33%		2014-12-15
	Gel	0.3%/2.5%		2016-05-04
	Spray	0.05%		2008-09-29

International Patents for Galderma Labs Drugs

Country	Patent Number	Estimated Expiration
Russian Federation	2016103753
Argentina	044050
Hong Kong	1204975
South Korea	20150028252
Cyprus	1109307
South Korea	102127022
Mexico	2014014560

Supplementary Protection Certificates for Galderma Labs Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1224170	SPC/GB15/018	United Kingdom		PRODUCT NAME: NINTEDANIB*, THE TAUTOMERS AND THE SALTS THEREOF, IN PARTICULAR NINTEDANIB AND PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF, SPECIFICALLY NINTEDANIB ESILATE. *NINTEDANIB IS 3-Z-(1-(4-N-((4-METHYL-PIPERAZIN-1-YL)-METHYLCARBONYL)-N-METHYL-AMINO)-A; REGISTERED: UK EU/1/14/954/001 20141125; UK EU/1/14/954/002 20141125; UK EU/1/14/954/003 20141125; UK EU/1/14/954/004 20141125
0230742	2001C/040	Belgium		PRODUCT NAME: MONOHYDRATE DU CHLORHYDRATE DE N,N-DIMETHYL-1-4-CHLOROPHENYL)CYCLOBUTYL-3-METHYLBUTYLAMINE ET COMPOSITIONS PHARMACEUTIQUES LE CONTENANT; NAT. REGISTRTION NO/DATE: 479 IS 52 F 5 20010425; FIRST REGISTRATION: CH 54770 19990113
1730131	62/2014	Austria		PRODUCT NAME: (1S)-1,5-ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY(PHENYL)METHYL)PHENYL)-D-GLUCITOL (EMPAGLIFLOZIN); REGISTRATION NO/DATE: EU/1/14/930 (MITTEILUNG) 20140527
1458369	132008901685368	Italy		PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618
1631293	2014C/042	Belgium		PRODUCT NAME: MIRVASO (BRIMONIDINE) EN FARMACEUTISCHE ZOUTEN DAARVAN VOOR GEBRUIK ALS MEDICIJN VOOR HET BEHANDELEN VAN ROSACEA GEINDUCEERDE ROODHEID; AUTHORISATION NUMBER AND DATE: EU/1/13/904 20140221
0591275	SPC/GB05/030	United Kingdom		PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221
1631293	CR 2014 00031	Denmark		PRODUCT NAME: BRIMONIDIN OG ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BRIMONIDIN TARTRAT; REG. NO/DATE: EU/1/13/904/001-003 20140221

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Galderma Labs
• Galderma Labs Lp