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Serving leading biopharmaceutical companies globally:

Queensland Health
Novartis
US Department of Justice
Moodys
Cantor Fitzgerald
UBS
Express Scripts
Johnson and Johnson
Dow
Farmers Insurance

Generated: October 22, 2017

DrugPatentWatch Database Preview

Galderma Labs Lp Company Profile

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What is the competitive landscape for GALDERMA LABS LP, and when can generic versions of GALDERMA LABS LP drugs launch?

GALDERMA LABS LP has twenty-three approved drugs.

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

There are three hundred and seventy-six patent family members on GALDERMA LABS LP drugs in thirty-four countries and ninety supplementary protection certificates in fifteen countries.

Summary for Applicant: Galderma Labs Lp

International Patents:376
US Patents:60
Tradenames:15
Ingredients:13
NDAs:23
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
METVIXIA
methyl aminolevulinate hydrochloride
CREAM;TOPICAL021415-001Jul 27, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
Galderma Labs Lp
TRI-LUMA
fluocinolone acetonide; hydroquinone; tretinoin
CREAM;TOPICAL021112-001Jan 18, 2002RXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs Lp
DIFFERIN
adapalene
SOLUTION;TOPICAL020338-001May 31, 1996DISCNYesNo► Subscribe► Subscribe► Subscribe
Galderma Labs Lp
PERIOSTAT
doxycycline hyclate
TABLET;ORAL050783-001Feb 2, 2001DISCNYesNo► Subscribe► Subscribe► Subscribe
Galderma Labs Lp
SOOLANTRA
ivermectin
CREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs Lp
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008ABRXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs Lp
DESOWEN
desonide
OINTMENT;TOPICAL071425-001Jun 15, 1988ABRXNoNo► Subscribe► Subscribe► Subscribe
Galderma Labs Lp
DIFFERIN
adapalene
LOTION;TOPICAL022502-001Mar 17, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs Lp
METROGEL
metronidazole
GEL;TOPICAL019737-001Nov 22, 1988ABRXYesYes► Subscribe► Subscribe► Subscribe
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Expired Patents for Galderma Labs Lp

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 LP drugs

Drugname Dosage Strength Tradename Submissiondate
ivermectin
Cream1%
SOOLANTRA
12/30/2016
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 Lp

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
8,729,127Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders► 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
8,921,423Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid► Subscribe
8,993,571Compounds, 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
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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 Lp Drugs

Country Document Number Estimated Expiration
Singapore189896► Subscribe
Australia695806► Subscribe
New Zealand528197► Subscribe
Portugal1631293► Subscribe
South Korea20150055082► Subscribe
Russian Federation2012145616► Subscribe
South Korea20060004667► Subscribe
Japan2012144554► Subscribe
Canada2656456► Subscribe
Argentina008637► 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 Lp Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/042United Kingdom► SubscribePRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020418
90038-5Sweden► SubscribePRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140203
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
C/GB98/002United Kingdom► SubscribePRODUCT NAME: TAZAROTENE : ETHYL 6-(2-(4,4-DIMETHYLTHIOCHROMAN-6-YL) ETHYNYL) NICOTINOATE; REGISTERED: DE 37393.00.00 19961203; DE 37393.01.00 19961203; UK 00426/0097 19970730; UK 00426/0096 19970730
C/GB06/032United Kingdom► SubscribePRODUCT NAME: ENTECAVIR-(2-AMINO-1,9-DIHYDRO-9-((1S,3R,4S)-4-HYDROXY-3-(HYDROXYMETHYL)-2-METHYLENE CYCLOPENTYL)-6H-PURIN-6-ONE AND HYDRATES THEREOF, PARTICULARLY THE MONOHYDRATE; REGISTERED: UK EU/1/06/343/001 20060626; UK EU/1/06/343/002 20060626; UK EU/1/06/343/003 20060626; UK EU/1/06/343/004 20060626; UK EU/1/06/343/005 20060626
0812Netherlands► SubscribePRODUCT NAME: 3-(6-((1-(2,2-DIFLUOR-1,3-BENZODIOXOL-5-YL)CYCLOPROPAANCARBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOEZUUR, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1059 20151124
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
/2015Austria► SubscribePRODUCT NAME: IVERMECTIN; NAT. REGISTRATION NO/DATE: 136170 20150602; FIRST REGISTRATION: MT MA 117/01101 20150402
0Finland► Subscribe
C/GB05/030United Kingdom► SubscribePRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221
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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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Deloitte
Baxter
Cipla
Federal Trade Commission
Mallinckrodt
US Department of Justice
Cerilliant
Covington
Boehringer Ingelheim
Daiichi Sankyo

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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ISSN: 2162-2639

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