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Serving 500+ biopharmaceutical companies globally:

Cipla
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Cantor Fitzgerald
Express Scripts
Merck
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US Army
Queensland Health
Farmers Insurance
Harvard Business School

Generated: August 21, 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 sixty-three patent family members on GALDERMA LABS LP drugs in thirty-four countries.

Summary for Applicant: Galderma Labs Lp

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
DIFFERIN
adapalene
GEL;TOPICAL021753-001Jun 19, 2007ABRXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs Lp
DIFFERIN
adapalene
SOLUTION;TOPICAL020338-001May 31, 1996DISCNYesNo► Subscribe► Subscribe► Subscribe
Galderma Labs Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 2006RXYesYes► Subscribe► SubscribeY ► 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
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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
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008► Subscribe► Subscribe
Galderma Labs Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 2006► Subscribe► Subscribe
Galderma Labs Lp
DIFFERIN
adapalene
SOLUTION;TOPICAL020338-001May 31, 1996► Subscribe► Subscribe
Galderma Labs Lp
METROGEL
metronidazole
GEL;TOPICAL019737-001Nov 22, 1988► Subscribe► Subscribe
Galderma Labs Lp
DIFFERIN
adapalene
SOLUTION;TOPICAL020338-001May 31, 1996► 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
8,586,586Methods and compositions for treating or preventing erythema► Subscribe
9,258,687Method and system for providing tiered access to communication network resources► Subscribe
7,838,563Compounds, formulations, and methods for ameliorating telangiectasias► Subscribe
8,275,349Method and system for providing tiered priority access to communication network resources► 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
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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
BrazilPI0410503► Subscribe
European Patent Office3002004► Subscribe
Hong Kong1204996► Subscribe
CroatiaP20150957► Subscribe
Japan5074401► 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
2015 00045Denmark► SubscribePRODUCT NAME: IVERMECTIN, 22, 23-DIHYDROAVERMECTINB1A + 22,23-DIHRODROAVERMECTIN B1B FOR USE IN THE TREATMNET OF RESACEA; NAT. REG. NO/DATE: 54123 20150422; FIRST REG. NO/DATE: MT MA 117/01101 20150402
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
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
1458369/01Switzerland► SubscribePRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
00675Netherlands► SubscribePRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
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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 500+ biopharmaceutical companies globally:

US Department of Justice
UBS
Chinese Patent Office
Queensland Health
Citi
AstraZeneca
Federal Trade Commission
Baxter
US Army
Chubb

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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