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Serving hundreds of leading biopharmaceutical companies globally:

Dow
QuintilesIMS
Queensland Health
Fish and Richardson
Julphar
Moodys
Accenture
Deloitte
US Department of Justice

Generated: June 21, 2018

DrugPatentWatch Database Preview

Galderma Labs Company Profile

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Summary for Galderma Labs
International Patents:371
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 EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes 8,445,543 ➤ Sign Up ➤ Sign Up
Galderma Labs Lp SOOLANTRA ivermectin CREAM;TOPICAL 206255-001 Dec 19, 2014 RX Yes Yes 9,782,425 ➤ Sign Up ➤ Sign Up
Galderma Labs Lp EPIDUO adapalene; benzoyl peroxide GEL;TOPICAL 022320-001 Dec 8, 2008 AB RX Yes Yes 7,964,202 ➤ Sign Up Y ➤ Sign Up
Galderma Labs EPIDUO FORTE adapalene; benzoyl peroxide GEL;TOPICAL 207917-001 Jul 15, 2015 RX Yes Yes 9,387,187 ➤ 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

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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 METROGEL metronidazole GEL;TOPICAL 019737-001 Nov 22, 1988 4,837,378 ➤ Sign Up
Galderma Labs Lp DIFFERIN adapalene SOLUTION;TOPICAL 020338-001 May 31, 1996 4,717,720 ➤ Sign Up
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 RE34440 ➤ Sign Up
Galderma Labs Lp DIFFERIN adapalene CREAM;TOPICAL 020748-001 May 26, 2000 4,717,720 ➤ 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 Lotion 0.05% ➤ Subscribe 2006-03-27
➤ Subscribe Topical Shampoo 0.05% ➤ Subscribe 2008-01-09
➤ Subscribe Topical Gel 1% ➤ Subscribe 2008-10-21
➤ Subscribe Gel 0.1%/2.5% ➤ Subscribe 2011-12-30
➤ 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 Topical Gel 0.30% ➤ Subscribe 2009-09-15
➤ Subscribe Topical Gel 0.33% ➤ Subscribe 2014-12-15
➤ Subscribe Cream 1% ➤ Subscribe 2016-12-30

Non-Orange Book US 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
8,658,189 Methods of treating acne ➤ Sign Up
9,901,556 Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders ➤ Sign Up
8,921,423 Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid ➤ Sign Up
5,886,038 Composition and method for treatment of psoriasis ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Galderma Labs Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB99/001 United Kingdom ➤ Sign Up PRODUCT 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
C0010 France ➤ Sign Up PRODUCT NAME: AMINOLEVULINATE DE METHYLE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 30885 20060919; FIRST REGISTRATION: SE - 16338 20010615
C/GB02/030 United Kingdom ➤ Sign Up PRODUCT NAME: BOSENTAN 4-(1,1-DIMETHYLETHYL)-N-(6-(2-HYDROXYETHOXY)-5-(2-METHOXYPHENOXY)-2(PYRIMIDIN-2-YL)PYRIMIDIN-4-YL)BENZENESULFONAMIDE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS
C/GB03/005 United Kingdom ➤ Sign Up PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Daiichi Sankyo
Citi
Chubb
McKesson
Julphar
Mallinckrodt
Baxter
Johnson and Johnson

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.