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Last Updated: January 28, 2020

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GALDERMA LABS LP Company Profile

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Summary for GALDERMA LABS LP
International Patents:356
US Patents:60
Tradenames:15
Ingredients:13
NDAs:23

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 SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 AB RX Yes Yes 8,815,816   Start Trial Y   Start Trial
Galderma Labs Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005 AT RX Yes Yes   Start Trial   Start Trial
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes 8,709,478   Start Trial   Start Trial
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes 7,820,186   Start Trial Y   Start Trial
Galderma Labs Lp PERIOSTAT doxycycline hyclate TABLET;ORAL 050783-001 Feb 2, 2001 DISCN Yes No   Start Trial   Start Trial
Galderma Labs Lp TRI-LUMA fluocinolone acetonide; hydroquinone; tretinoin CREAM;TOPICAL 021112-001 Jan 18, 2002 RX Yes Yes 8,653,053   Start Trial Y   Start 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 LP

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 4,717,720   Start Trial
Galderma Labs Lp DIFFERIN adapalene GEL;TOPICAL 021753-001 Jun 19, 2007 RE34440   Start Trial
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 5,789,395   Start Trial
Galderma Labs Lp CLOBEX clobetasol propionate SPRAY;TOPICAL 021835-001 Oct 27, 2005 5,972,920   Start Trial
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 5,952,372   Start Trial
Galderma Labs Lp DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996 4,717,720   Start Trial
>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 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
➤ 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 LP Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1620113 C01620113/01 Switzerland   Start Trial PRODUCT NAME: IVERMECTINUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 65561 20.12.2016
0758327 SPC/GB06/009 United Kingdom   Start Trial PRODUCT NAME: (R-(R*,R*))-N-(3-(1-(5,6-DIHYDRO-4-HYDROXY-2-OXO-6-(2-PHENYLETHYL)-6-PROPYL-2H-PYRAN-3-YL)PROPYL)PHENYL)-5-(TRIFLUOROMETHYL)-2-PYRIDINESULFONAMIDE OR A PHARMACEUTICAL SALT THEREOF = (TIPRANAVIR OR A PHARMACEUTICAL SALT THEREOF); REGISTERED: CH 57330 20050825; UK EU/1/05/315/001 20051025
1631293 300683 Netherlands   Start Trial PRODUCT NAME: BRIMONIDINE EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN VOOR TOEPASSING ALS GENEESMIDDEL VOOR DE BEHANDELING VAN DOOR ROSACEA GEINDUCEERDE ROODHEID; REGISTRATION NO/DATE: EU/1/13/904 20140225
1532149 8/2012 Austria   Start Trial PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION UND DESSEN SALZE, INSBES. LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 (MITTEILUNG) 20110830
1631293 1490049-2 Sweden   Start Trial PRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221
0186118 SPC/GB05/029 United Kingdom   Start Trial PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Moodys
Dow
Boehringer Ingelheim
Baxter

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