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Serving leading biopharmaceutical companies globally:

Citi
US Army
Johnson and Johnson
Merck
US Department of Justice
Boehringer Ingelheim
Farmers Insurance
Covington
Deloitte
McKesson

Generated: December 16, 2017

DrugPatentWatch Database Preview

Galderma Labs Company Profile

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What is the competitive landscape for GALDERMA LABS, and what generic alternatives to GALDERMA LABS drugs are available?

GALDERMA LABS has twenty-five approved drugs.

There are sixty-eight US patents protecting GALDERMA LABS drugs and there have been two Paragraph IV challenges on GALDERMA LABS drugs in the past three years.

There are four hundred and seven patent family members on GALDERMA LABS drugs in thirty-four countries and ninety-two supplementary protection certificates in fifteen countries.

Summary for Galderma Labs

International Patents:407
US Patents:68
Tradenames:16
Ingredients:13
NDAs:25
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma LabsEPIDUO FORTEadapalene; benzoyl peroxideGEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Galderma LabsEPIDUO FORTEadapalene; benzoyl peroxideGEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Galderma LabsEPIDUO FORTEadapalene; benzoyl peroxideGEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Galderma Labs LpEPIDUOadapalene; benzoyl peroxideGEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► SubscribeY► Subscribe
Galderma LabsEPIDUO FORTEadapalene; benzoyl peroxideGEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Galderma Labs LpSOOLANTRAivermectinCREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Galderma LabsCLOBEXclobetasol propionateSHAMPOO;TOPICAL021644-001Feb 5, 2004ABRXYesYes► Subscribe► SubscribeY► Subscribe
Galderma LabsEPIDUO FORTEadapalene; benzoyl peroxideGEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Galderma Labs LpMETROGELmetronidazoleGEL;TOPICAL021789-001Jun 30, 2005ABRXYesYes► Subscribe► SubscribeY► Subscribe
Galderma Labs LpCAPEXfluocinolone acetonideSHAMPOO;TOPICAL020001-001Aug 27, 1990RXYesYes► Subscribe► Subscribe► Subscribe
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Expired Patents for Galderma Labs

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs LpDIFFERINadapaleneSOLUTION;TOPICAL020338-001May 31, 1996► Subscribe► Subscribe
Galderma Labs LpMETROGELmetronidazoleGEL;TOPICAL019737-001Nov 22, 1988► Subscribe► Subscribe
Galderma Labs LpORACEAdoxycyclineCAPSULE;ORAL050805-001May 26, 2006► Subscribe► Subscribe
Galderma Labs LpDIFFERINadapaleneCREAM;TOPICAL020748-001May 26, 2000► Subscribe► Subscribe
Galderma Labs LpEPIDUOadapalene; benzoyl peroxideGEL;TOPICAL022320-001Dec 8, 2008► Subscribe► Subscribe
Galderma Labs LpDIFFERINadapaleneGEL;TOPICAL021753-001Jun 19, 2007► Subscribe► Subscribe
Galderma Labs LpCLOBEXclobetasol propionateLOTION;TOPICAL021535-001Jul 24, 2003► Subscribe► Subscribe
Galderma Labs LpDIFFERINadapaleneSOLUTION;TOPICAL020338-001May 31, 1996► Subscribe► Subscribe
Galderma Labs LpDIFFERINadapaleneGEL;TOPICAL021753-001Jun 19, 2007► Subscribe► Subscribe
Galderma Labs LpMETVIXIAmethyl aminolevulinate hydrochlorideCREAM;TOPICAL021415-001Jul 27, 2004► Subscribe► Subscribe
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Paragraph IV activity for GALDERMA LABS drugs

Drugname Dosage Strength Tradename Submissiondate
ivermectinCream1%SOOLANTRA12/30/2016
adapalene and benzoyl peroxideGel0.3%/2.5%EPIDUO FORTE5/4/2016
brimonidineTopical Gel0.33%MIRVASO12/15/2014
adapalene and benzoyl peroxideGel0.1%/2.5%EPIDUO12/30/2011
adapaleneTopical Gel0.30%DIFFERIN9/15/2009
doxycyclineDelayed-release Capsules40 mgORACEA12/11/2008
metronidazoleTopical Gel1%METROGEL10/21/2008
clobetasol propionateSpray0.05%CLOBEX9/29/2008
clobetasol propionateTopical Shampoo0.05%CLOBEX1/9/2008
clobetasol propionateLotion0.05%CLOBEX3/27/2006

Non-Orange Book Patents for Galderma Labs

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,921,423Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid► Subscribe
8,624,678Output stage of a power amplifier having a switched-bulk biasing and adaptive biasing► Subscribe
9,258,687Method and system for providing tiered access to communication network resources► Subscribe
9,333,172Topical skin care composition► Subscribe
7,544,674Topical skin care composition► Subscribe
8,611,848Method and system for providing tiered access to communication network resources► Subscribe
5,886,038 Composition and method for treatment of psoriasis► Subscribe
7,838,563Compounds, formulations, and methods for ameliorating telangiectasias► Subscribe
8,653,140Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► Subscribe
8,892,066Method and system for providing tiered priority access to communication network resources► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Galderma Labs Drugs

Country Document Number Estimated Expiration
Norway333468► Subscribe
South Korea20060040755► Subscribe
France2854074► Subscribe
Denmark1485080► Subscribe
France2837101► Subscribe
European Patent Office1087747► Subscribe
Brazil0314882► Subscribe
Japan2002513386► Subscribe
Germany60212613► Subscribe
Japan4451930► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Galderma Labs Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB98/030United Kingdom► SubscribePRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
C/GB96/060United Kingdom► SubscribePRODUCT NAME: IBANDRONIC ACID ((1-HYDROXY-3-(METHYLPENTYLAMINO) - PROPYLIDINE)-DIPHOSPHONIC ACID); REGISTERED: UK EU/1/96/012/001 19960625
C/GB03/005United Kingdom► SubscribePRODUCT NAME: D-MEDETOMIDINE (4-((1S)-1-(2,3-DIMETHYLPHENYL)ETHYL)-1H-IMIDAZOLE) AND ITS NON-TOXIC PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE HYDROCHLORIDE; REGISTERED: UK EU/2/02/033/001 20020830
C/GB99/020United Kingdom► SubscribePRODUCT NAME: NEVIRAPINE = 11-CYCLOPROPYL-5,11-DIHYDRO-4-METHYL-6H-DIPYRIDO(3,2-B:2',3'-E)(1,4)DIAZEPIN-6-ONE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTERED: CH 54393 19971223; UK EU/1/97/055/001 19980205
C/GB99/001United Kingdom► SubscribePRODUCT NAME: CLOPIDOGREL HYDROGEN SULPHATE, THE DEXTROROTATORY ISOMER OF ALPHA-(4,5,6,7-TETRAHYDROTHIENO(3,2-C)PYRID-5-YL)(2-CHLOROPHENYL) METHYL ACETATE AS THE HYDROGEN SULPHATE SALT; REGISTERED: UK EU/1/98/069/001 19980715; UK EU/1/98/069/002 19980715; UK EU/1/98/069/003 19980715
00756Netherlands► SubscribePRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402
60032Netherlands► SubscribePRODUCT NAME: ACIDUM IBANDRONICUM, DESGEWENST IN DE VORM VAN EEN FARMACOLO- GISCH AANVAARDBAAR ZOUT OF IN DE VORM VAN EEN ESTER MET METHANOL,ETHANOL,2-PROPANOL OF 2-METHYLPROPANOL, OF IN DE VORM VEN EEN HYDRAAT,I.H.B.MONONATRIUM IBANDRONAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/96/012/001 19960625
90049-2Sweden► SubscribePRODUCT NAME: BRIMONIDIN OCH FARMACEUTISKA SALTER DAERAV; REG. NO/DATE: EU/1/13/904 20140221
2015000079Germany► SubscribePRODUCT NAME: IVERMECTIN ZU SEINER VERWENDUNG FUER DIE BEHANDLUNG VON ROSAZEA; NAT. REGISTRATION NO/DATE: 92429.00.00 20150429; FIRST REGISTRATION: MALTA MA 117/01101 20150402
2008000041Germany► SubscribePRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Citi
McKinsey
Chinese Patent Office
US Army
Boehringer Ingelheim
Farmers Insurance
Moodys
US Department of Justice
Baxter
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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