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Last Updated: November 22, 2024

GALDERMA LABS LP Company Profile


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Summary for GALDERMA LABS LP
International Patents:421
US Patents:61
Tradenames:18
Ingredients:16
NDAs:26

Drugs and US Patents for GALDERMA LABS LP

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 DESOWEN desonide OINTMENT;TOPICAL 071425-001 Jun 15, 1988 AB RX No No ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp AKLIEF trifarotene CREAM;TOPICAL 211527-001 Oct 4, 2019 RX Yes Yes 7,807,708 ⤷  Sign Up Y Y ⤷  Sign Up
Galderma Labs Lp TWYNEO benzoyl peroxide; tretinoin CREAM;TOPICAL 214902-001 Jul 26, 2021 RX Yes Yes 8,617,580 ⤷  Sign Up Y ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes 10,206,939 ⤷  Sign Up ⤷  Sign Up
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 AB RX Yes Yes 8,163,725 ⤷  Sign Up Y ⤷  Sign Up
Galderma Labs Lp METROLOTION metronidazole LOTION;TOPICAL 020901-001 Nov 24, 1998 AB RX Yes Yes ⤷  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

Expired US Patents for GALDERMA LABS LP

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 8,936,800 ⤷  Sign Up
Galderma Labs Lp DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996 4,717,720 ⤷  Sign Up
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 7,838,558 ⤷  Sign Up
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 8,809,305 ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 8,415,311 ⤷  Sign Up
Galderma Labs Lp MIRVASO brimonidine tartrate GEL;TOPICAL 204708-001 Aug 23, 2013 8,859,551 ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for GALDERMA LABS LP drugs
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 Spray 0.05% ➤ Subscribe 2008-09-29
➤ Subscribe Delayed-release Capsules 40 mg ➤ Subscribe 2008-12-11

Supplementary Protection Certificates for GALDERMA LABS LP Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1631293 C01631293/01 Switzerland ⤷  Sign Up PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: SWISSMEDIC 65180 21.11.2014
1458369 SZ 31/2008 Austria ⤷  Sign Up PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
1948158 300810 Netherlands ⤷  Sign Up PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, IE. TRINATRIUM (3-((LS,3R)-1-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-METHYL-2'-(PENTANOYL(2"-(TETRAZOL-5-YLAAT)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT) HEMIPENTAHYDRAAT; REGISTRATION NO/DATE: EU/1/15/1058 20151123
1532149 2011C/038 Belgium ⤷  Sign Up PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2--YLMETHYL)-3,7-DIHYDROPURIN-2,6-DIONE SES ENANTIOMERES OU L'UN DES SES SELS, EN PARTICULIER LA LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/11/707/001 20110830
2441753 SPC/GB17/036 United Kingdom ⤷  Sign Up 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
0284288 SPC/GB98/002 United Kingdom ⤷  Sign Up PRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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