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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Argus Health
Fuji
Merck
UBS
Cipla
Federal Trade Commission
Moodys

Generated: October 15, 2018

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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-five approved drugs.

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

Summary for Galderma Labs
US Patents:69
Tradenames:16
Ingredients:13
NDAs:25

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 METROCREAM metronidazole CREAM;TOPICAL 020531-001 Sep 20, 1995 AB RX Yes Yes ➤ Sign Up ➤ Sign Up
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes 8,241,649 ➤ Sign Up Y ➤ Sign Up
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes 8,729,127 ➤ Sign Up ➤ Sign Up
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 RX Yes Yes 8,247,395 ➤ Sign Up Y ➤ Sign Up
Galderma Labs Lp METROGEL metronidazole GEL;TOPICAL 021789-001 Jun 30, 2005 AB RX Yes Yes 6,881,726 ➤ Sign Up Y ➤ 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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Expired US Patents for Galderma Labs

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 5,789,395 ➤ Sign Up
Galderma Labs Lp DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996 RE34440 ➤ Sign Up
Galderma Labs Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005 5,972,920 ➤ Sign Up
Galderma Labs Lp METVIXIA methyl aminolevulinate hydrochloride CREAM;TOPICAL 021415-001 Jul 27, 2004 6,034,267 ➤ 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

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Paragraph IV (Patent) Challenges for GALDERMA LABS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ Subscribe Topical Gel 0.30% ➤ Subscribe 2009-09-15

Supplementary Protection Certificates for Galderma Labs Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000069 Germany ➤ Sign Up PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2014 00035 Denmark ➤ Sign Up PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130
11/039 Ireland ➤ Sign Up PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-Y1)-7-BUT-2INYL-3-METHYL-1-(4- METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2,6-DION THE ENATIOMERS AND SALTS THEROF-ESPECIALLY LINAGLIPTIN."LINAGLIPTIN=((R)-8-(3-AMINOPIPERIDIN-1-YL)- 7-BUT-2-INYL-3-METHYL-L-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6- DION") (IUPAC); REGISTRATION NO/DATE: EU/1/11/707/001-EU/1/11/707/011 20110824
2014 00031 Denmark ➤ Sign Up PRODUCT NAME: BRIMONIDIN OG ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BRIMONIDIN TARTRAT; REG. NO/DATE: EU/1/13/904/001-003 20140221
C/GB08/018 United Kingdom ➤ Sign Up PRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
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Here is a list of applicants with similar names.

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Chubb
Argus Health
Accenture
Harvard Business School
US Department of Justice
Moodys
Cipla

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