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Serving 500+ biopharmaceutical companies globally:

Queensland Health
US Army
Novartis
Chubb
Farmers Insurance
Mallinckrodt
Federal Trade Commission
Boehringer Ingelheim
Fish and Richardson
McKesson

Generated: August 17, 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 three hundred and ninety-three patent family members on GALDERMA LABS drugs in thirty-four countries.

Summary for Applicant: Galderma Labs

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
EPIDUO FORTE
adapalene; benzoyl peroxide
GEL;TOPICAL207917-001Jul 15, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Galderma Labs Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Galderma Labs Lp
SOOLANTRA
ivermectin
CREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Galderma Labs Lp
SOOLANTRA
ivermectin
CREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Galderma Labs Lp
SOOLANTRA
ivermectin
CREAM;TOPICAL206255-001Dec 19, 2014RXYesYes► 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
DIFFERIN
adapalene
CREAM;TOPICAL020748-001May 26, 2000► 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
EPIDUO
adapalene; benzoyl peroxide
GEL;TOPICAL022320-001Dec 8, 2008► Subscribe► Subscribe
Galderma Labs Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 2006► 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
8,921,423Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid► Subscribe
9,258,687Method and system for providing tiered access to communication network resources► Subscribe
5,886,038 Composition and method for treatment of psoriasis► Subscribe
8,993,571Compounds, formulations, and methods for treating or preventing inflammatory skin disorders► Subscribe
8,586,586Methods and compositions for treating or preventing erythema► 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
Japan4638234► Subscribe
European Patent Office2629757► Subscribe
Denmark1620113► Subscribe
Portugal2444068► Subscribe
Canada2803922► 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/GB96/060United Kingdom► SubscribePRODUCT NAME: IBANDRONIC ACID ((1-HYDROXY-3-(METHYLPENTYLAMINO) - PROPYLIDINE)-DIPHOSPHONIC ACID); REGISTERED: UK EU/1/96/012/001 19960625
C/GB06/009United Kingdom► SubscribePRODUCT NAME: (R-(R*,R*))-N-(3-(1-(5,6-DIHYDRO-4-HYDROXY-2-OXO-6-(2-PHENYLETHYL)-6-PROPYL-2H-PYRAN-3-YL)PROPYL)PHENYL)-5-(TRIFLUOROMETHYL)-2-PYRIDINESULFONAMIDE OR A PHARMACEUTICAL SALT THEREOF = (TIPRANAVIR OR A PHARMACEUTICAL SALT THEREOF); REGISTERED: CH 57330 20050825; UK EU/1/05/315/001 20051025
31/2008Austria► SubscribePRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID
14/055Ireland► SubscribePRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN ((1S)-1,5- ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY))PHENYL)METHYL)PHENYL)- D-GLUCITOL); REGISTRATION NO/DATE: EU/1/14/930 20140522
1631293/01Switzerland► SubscribePRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: SWISSMEDIC 65180 21.11.2014
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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 500+ biopharmaceutical companies globally:

Teva
Farmers Insurance
Cantor Fitzgerald
UBS
Argus Health
QuintilesIMS
Chinese Patent Office
Fish and Richardson
Novartis
AstraZeneca

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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