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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Covington
Harvard Business School
QuintilesIMS
Citi
Moodys
UBS
Healthtrust
Boehringer Ingelheim
Novartis

Generated: October 20, 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 three 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 supplementary protection certificates in fifteen countries.

Summary for Applicant: 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 Labs Lp
CAPEX
fluocinolone acetonide
SHAMPOO;TOPICAL020001-001Aug 27, 1990RXYesYes► Subscribe► Subscribe► Subscribe
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs Lp
MIRVASO
brimonidine tartrate
GEL;TOPICAL204708-001Aug 23, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs Lp
SOOLANTRA
ivermectin
CREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs
CLOBEX
clobetasol propionate
SHAMPOO;TOPICAL021644-001Feb 5, 2004ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs Lp
SOOLANTRA
ivermectin
CREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs Lp
METROGEL
metronidazole
GEL;TOPICAL021789-001Jun 30, 2005ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs
CLOBEX
clobetasol propionate
SHAMPOO;TOPICAL021644-001Feb 5, 2004ABRXYesYes► 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 Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 2006► Subscribe► Subscribe
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008► Subscribe► Subscribe
Galderma Labs Lp
DIFFERIN
adapalene
CREAM;TOPICAL020748-001May 26, 2000► Subscribe► Subscribe
Galderma Labs Lp
METROGEL
metronidazole
GEL;TOPICAL019737-001Nov 22, 1988► Subscribe► Subscribe
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008► Subscribe► Subscribe
Galderma Labs Lp
DIFFERIN
adapalene
SOLUTION;TOPICAL020338-001May 31, 1996► Subscribe► Subscribe
Galderma Labs Lp
DIFFERIN
adapalene
CREAM;TOPICAL020748-001May 26, 2000► Subscribe► Subscribe
Galderma Labs Lp
METVIXIA
methyl aminolevulinate hydrochloride
CREAM;TOPICAL021415-001Jul 27, 2004► Subscribe► Subscribe
Galderma Labs Lp
CLOBEX
clobetasol propionate
LOTION;TOPICAL021535-001Jul 24, 2003► Subscribe► Subscribe
Galderma Labs Lp
DIFFERIN
adapalene
GEL;TOPICAL021753-001Jun 19, 2007► Subscribe► Subscribe
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Paragraph IV activity for GALDERMA LABS drugs

Drugname Dosage Strength Tradename Submissiondate
ivermectin
Cream1%
SOOLANTRA
12/30/2016
adapalene and benzoyl peroxide
Gel0.3%/2.5%
EPIDUO FORTE
5/4/2016
brimonidine
Topical Gel0.33%
MIRVASO
12/15/2014
adapalene and benzoyl peroxide
Gel0.1%/2.5%
EPIDUO
12/30/2011
adapalene
Topical Gel0.30%
DIFFERIN
9/15/2009
doxycycline
Delayed-release Capsules40 mg
ORACEA
12/11/2008
metronidazole
Topical Gel1%
METROGEL
10/21/2008
clobetasol propionate
Spray0.05%
CLOBEX
9/29/2008
clobetasol propionate
Topical Shampoo0.05%
CLOBEX
1/9/2008
clobetasol propionate
Lotion0.05%
CLOBEX
3/27/2006

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
8,624,678Output 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
8,892,066Method and system for providing tiered priority access to communication network resources► Subscribe
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
5,886,038 Composition and method for treatment of psoriasis► Subscribe
7,838,563Compounds, formulations, and methods for ameliorating telangiectasias► Subscribe
9,622,994Method for the treatment of acne using pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid► Subscribe
8,993,571Compounds, formulations, and methods for treating or preventing inflammatory skin disorders► Subscribe
8,275,349Method and system for providing tiered priority access to communication network resources► Subscribe
8,653,140Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► 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
Slovenia1458369► Subscribe
Poland376715► Subscribe
Japan2005513146► Subscribe
Portugal1761266► Subscribe
World Intellectual Property Organization (WIPO)02080932► Subscribe
Japan2016523968► Subscribe
European Patent Office1383508► Subscribe
France2837101► Subscribe
Denmark1761266► Subscribe
Russian Federation2001101891► 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/GB01/003United Kingdom► SubscribePRODUCT NAME: N-(4-(2(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY)BENZYL)THIAZOLIDINE-2,4-DIONE MALEIC ACID, "ROSIGLITAZONE MALEATE", ITS TAUTOMERS AND PHARMACEUTICALLY ACCEPTABLE SOLVATES; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711
C/GB98/037United Kingdom► SubscribePRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE) (GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS.; REGISTERED: CH 54 250.02 19970815; UK EU/1/97/046/001 19970827; UK EU/1/97/046/002 19970827; UK EU/1/97/046/003 19970827; UK EU/1/97/046/004 19970827; UK EU/1/97/046/005 19970827; UK EU/1/97/046/006 19970827; UK EU/1/97/046/007 19970827; UK EU/1/97/046/008 19970827; UK EU/1/97/046/009 19970827
2014000036Germany► SubscribePRODUCT NAME: KRISTALLINE FORM DES (R)-2-(((3-METHYL-4-(2,2,2-TRIFLUORETHOXY)-2-PYRIDINYL)METHYL)SULFINYL)-1H-BENZIMIDAOLS; NAT. REGISTRATION NO/DATE: 87192.00.00 87193.00.00 87194.00.00 87195.00.00 20131118 FIRST REGISTRATION: SCHWEDEN 47911 47912 47913 47914 20130919
C0010France► SubscribePRODUCT NAME: AMINOLEVULINATE DE METHYLE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 30885 20060919; FIRST REGISTRATION: SE - 16338 20010615
2014 00055Denmark► SubscribePRODUCT NAME: TRAMETINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER TRAMETINIBDIMETHYLSULFOXID; REG. NO/DATE: EU/1/14/931/01-06 20140630
0810Netherlands► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, IE. TRINATRIURA (3-((LS,3R)-L-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONYL-L-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-ETHYL-2'-(PENTANOYL(2"-(TETRAZOL-5-YLAAT)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT) HEMIPENTAHYDRAAT; REGISTRATION NO/DATE: EU/1/15/1058 (C(2015) 8288) 20151123
C/GB95/010United Kingdom► SubscribePRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215
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
90039-3Sweden► SubscribePRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140130
2016000038Germany► SubscribePRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUM SALZKOMPLEX, D.H. TRINATRIUM-(3-((1 S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAT-(S)-3'-METHYL-2'-(PENTANOYL-(2"-(TETRAZOL-5-YLAT)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRAT)-HEMIPENTAHYDRAT.; REGISTRATION NO/DATE: EU/1/15/1058 20151119
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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:

Dow
Mallinckrodt
McKesson
Chinese Patent Office
Moodys
Argus Health
Teva
Johnson and Johnson
Colorcon
Harvard Business School

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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