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Last Updated: May 5, 2024

Galderma Labs Company Profile


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Summary for Galderma Labs
International Patents:405
US Patents:58
Tradenames:19
Ingredients:16
NDAs:28

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 SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes 8,415,311 ⤷  Try a Trial Y ⤷  Try a Trial
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes 8,080,537 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes 9,782,425 ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp PERIOSTAT doxycycline hyclate TABLET;ORAL 050783-001 Feb 2, 2001 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes 8,470,788 ⤷  Try a Trial Y ⤷  Try a Trial
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 AB RX Yes Yes 8,513,249 ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Galderma Labs

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs CLOBEX clobetasol propionate SHAMPOO;TOPICAL 021644-001 Feb 5, 2004 8,066,975 ⤷  Try a Trial
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 7,939,516 ⤷  Try a Trial
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 8,809,305 ⤷  Try a Trial
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 4,717,720 ⤷  Try a Trial
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 8,247,395 ⤷  Try a Trial
Galderma Labs Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005 5,972,920 ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for GALDERMA LABS drugs
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 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

Supplementary Protection Certificates for Galderma Labs Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2340828 122021000003 Germany ⤷  Try a Trial PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUM SALZKOMPLEX, D.H. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)-BIPHENYL-4-YL)-METHYL)-VALIN) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTANSAEUREETHYLESTER))NA 3 * X H 2 0, WORIN X 0 BIS 3 IST; REGISTRATION NO/DATE: EU/1/15/1058 20151119
2233112 132014902285293 Italy ⤷  Try a Trial PRODUCT NAME: FLUOCINOLONE ACETONIDE(ILUVIEN); AUTHORISATION NUMBER(S) AND DATE(S): 042616019, 20140530;PL27813/0001, 20120504
2340828 301088 Netherlands ⤷  Try a Trial PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, DAT WIL ZEGGEN (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)-BIFENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIFENYL-4-YL-4-(3-CARBOXYPROPIONYLAMINO)-2-METHYL-PENTAANZUURETHYLESTER))NA3-X H2O, WAARBIJ X 0 TOT EN MET 3 IS; REGISTRATION NO/DATE: EU/1/15/1058 20151123
1458369 SPC/GB10/005 United Kingdom ⤷  Try a Trial PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
0481754 SPC/GB06/032 United Kingdom ⤷  Try a Trial PRODUCT NAME: ENTECAVIR-(2-AMINO-1,9-DIHYDRO-9-((1S,3R,4S)-4-HYDROXY-3-(HYDROXYMETHYL)-2-METHYLENE CYCLOPENTYL)-6H-PURIN-6-ONE AND HYDRATES THEREOF, PARTICULARLY THE MONOHYDRATE; REGISTERED: UK EU/1/06/343/001 20060626; UK EU/1/06/343/002 20060626; UK EU/1/06/343/003 20060626; UK EU/1/06/343/004 20060626; UK EU/1/06/343/005 20060626
2137537 300674 Netherlands ⤷  Try a Trial PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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