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Generated: August 17, 2017
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.| 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;TOPICAL | 207917-001 | Jul 15, 2015 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Galderma Labs Lp | DIFFERIN | adapalene | CREAM;TOPICAL | 020748-001 | May 26, 2000 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Galderma Labs Lp | DIFFERIN | adapalene | SOLUTION;TOPICAL | 020338-001 | May 31, 1996 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
ivermectin | Cream | 1% | SOOLANTRA | 12/30/2016 |
adapalene and benzoyl peroxide | Gel | 0.3%/2.5% | EPIDUO FORTE | 5/4/2016 |
brimonidine | Topical Gel | 0.33% | MIRVASO | 12/15/2014 |
adapalene and benzoyl peroxide | Gel | 0.1%/2.5% | EPIDUO | 12/30/2011 |
adapalene | Topical Gel | 0.30% | DIFFERIN | 9/15/2009 |
doxycycline | Delayed-release Capsules | 40 mg | ORACEA | 12/11/2008 |
metronidazole | Topical Gel | 1% | METROGEL | 10/21/2008 |
clobetasol propionate | Spray | 0.05% | CLOBEX | 9/29/2008 |
clobetasol propionate | Topical Shampoo | 0.05% | CLOBEX | 1/9/2008 |
clobetasol propionate | Lotion | 0.05% | CLOBEX | 3/27/2006 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,921,423 | Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid | ► Subscribe | |||||||||||||||||||||||||||
| 9,258,687 | Method and system for providing tiered access to communication network resources | ► Subscribe | |||||||||||||||||||||||||||
| 5,886,038 | Composition and method for treatment of psoriasis | ► Subscribe | |||||||||||||||||||||||||||
| 8,993,571 | Compounds, formulations, and methods for treating or preventing inflammatory skin disorders | ► Subscribe | |||||||||||||||||||||||||||
| 8,586,586 | Methods 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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 4638234 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2629757 | ► Subscribe | |||||||||||||||||||||||||||
| Denmark | 1620113 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 2444068 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2803922 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB96/060 | United Kingdom | ► Subscribe | PRODUCT NAME: IBANDRONIC ACID ((1-HYDROXY-3-(METHYLPENTYLAMINO) - PROPYLIDINE)-DIPHOSPHONIC ACID); REGISTERED: UK EU/1/96/012/001 19960625 | ||||||||||||||||||||||||||
| C/GB06/009 | United Kingdom | ► Subscribe | PRODUCT 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 | ||||||||||||||||||||||||||
| 31/2008 | Austria | ► Subscribe | PRODUCT NAME: KOMBINATIONSPRAEPARAT ENTHALTEND ADAPALEN UND BENZOLYPEROXID | ||||||||||||||||||||||||||
| 14/055 | Ireland | ► Subscribe | PRODUCT 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 | ||||||||||||||||||||||||||
| 1631293/01 | Switzerland | ► Subscribe | PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: SWISSMEDIC 65180 21.11.2014 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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