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Last Updated: July 16, 2024

GALDERMA LABS LP Company Profile


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Summary for GALDERMA LABS LP
International Patents:405
US Patents:58
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 EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes 8,071,644 ⤷  Sign Up Y ⤷  Sign Up
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 AB RX Yes Yes 8,394,406 ⤷  Sign Up Y ⤷  Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes 8,415,311 ⤷  Sign Up Y ⤷  Sign Up
Galderma Labs Lp VECTICAL calcitriol OINTMENT;TOPICAL 022087-001 Jan 23, 2009 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 METROGEL metronidazole GEL;TOPICAL 021789-001 Jun 30, 2005 7,348,317 ⤷  Sign Up
Galderma Labs Lp CLOBEX clobetasol propionate LOTION;TOPICAL 021535-001 Jul 24, 2003 6,106,848 ⤷  Sign Up
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 7,232,572 ⤷  Sign Up
Galderma Labs Lp METROGEL metronidazole GEL;TOPICAL 019737-001 Nov 22, 1988 4,837,378 ⤷  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
1458369 132008901685368 Italy ⤷  Sign Up PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618
0481754 SPC/GB06/032 United Kingdom ⤷  Sign Up 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
0641330 SPC/GB04/034 United Kingdom ⤷  Sign Up PRODUCT NAME: PREGABALIN (S-(+)-4-AMINO-3(2-METHYLPROPYL)BUTANOIC ACID) OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACTIVE SALT.; REGISTERED: UK EU/1/04/279/001 20040706; UK EU/1/04/279/002 20040706; UK EU/1/04/279/003 20040706; UK EU/1/04/279/004 20040706; UK EU/1/04/279/005 20040706; UK EU/1/04/279/006 20040706; UK EU/1/04/279/025 20040706; UK EU/1/04/279/019 20040706; UK EU/1/04/279/020 20040706; UK EU/1/04/279/021 20040706; UK EU/1/04/279/022 20040706; UK EU/1/04/279/023 20040706; UK EU/1/04/279/024 20040706; UK EU/1/04/279/013 20040706; UK EU/1/04/279/014 20040706; UK EU/1/04/279/015 20040706; UK EU/1/04/279/016 20040706; UK EU/1/04/279/017 20040706; UK EU/1/04/279/018 20040706; UK EU/
2826776 CA 2021 00013 Denmark ⤷  Sign Up PRODUCT NAME: A COMBINATION OF (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) ....; REG. NO/DATE: EU/1/18/1306 20181106
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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