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Galderma Labs Company Profile
What is the competitive landscape for GALDERMA LABS, and when can generic versions of GALDERMA LABS drugs launch?
GALDERMA LABS has twenty-five approved drugs.
There are seventy US patents protecting GALDERMA LABS drugs.
There are three hundred and seventy-one patent family members on GALDERMA LABS drugs in thirty-three countries and ninety-eight supplementary protection certificates in fifteen countries.
Summary for Galderma Labs
| International Patents: | 371 |
| US Patents: | 70 |
| Tradenames: | 16 |
| Ingredients: | 13 |
| NDAs: | 25 |
Drugs and US Patents for Galderma Labs
| 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 | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | RX | Yes | Yes | 7,211,267 | ➤ Sign Up | ➤ Sign Up | ||||
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | AB | RX | Yes | Yes | 7,964,202 | ➤ Sign Up | Y | ➤ Sign Up | ||
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | RX | Yes | Yes | 8,470,364 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Galderma Labs | EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917-001 | Jul 15, 2015 | AB | RX | Yes | Yes | 9,381,179 | ➤ Sign Up | ➤ Sign Up | |||
| Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 021789-001 | Jun 30, 2005 | AB | RX | Yes | Yes | 7,348,317 | ➤ Sign Up | Y | ➤ Sign Up | ||
| Galderma Labs Lp | TRI-LUMA | fluocinolone acetonide; hydroquinone; tretinoin | CREAM;TOPICAL | 021112-001 | Jan 18, 2002 | RX | Yes | Yes | 8,653,053 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | RX | Yes | Yes | 8,470,788 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Expired US Patents for Galderma Labs
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | CLOBEX | clobetasol propionate | SPRAY;TOPICAL | 021835-001 | Oct 27, 2005 | 5,990,100 | ➤ Sign Up |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 5,789,395 | ➤ Sign Up |
| Galderma Labs Lp | DIFFERIN | adapalene | CREAM;TOPICAL | 020748-001 | May 26, 2000 | 4,717,720 | ➤ Sign Up |
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | 4,717,720 | ➤ Sign Up |
| Galderma Labs Lp | METVIXIA | methyl aminolevulinate hydrochloride | CREAM;TOPICAL | 021415-001 | Jul 27, 2004 | 6,034,267 | ➤ Sign Up |
| Galderma Labs Lp | DIFFERIN | adapalene | SOLUTION;TOPICAL | 020338-001 | May 31, 1996 | 4,717,720 | ➤ Sign Up |
| Galderma Labs Lp | CLOBEX | clobetasol propionate | SPRAY;TOPICAL | 021835-001 | Oct 27, 2005 | 5,972,920 | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Paragraph IV (Patent) Challenges for GALDERMA LABS drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Delayed-release Capsules | 40 mg | ➤ Subscribe | 2008-12-11 |
| ➤ Subscribe | Cream | 1% | ➤ Subscribe | 2016-12-30 |
| ➤ Subscribe | Topical Gel | 1% | ➤ Subscribe | 2008-10-21 |
| ➤ Subscribe | Lotion | 0.05% | ➤ Subscribe | 2006-03-27 |
| ➤ Subscribe | Topical Shampoo | 0.05% | ➤ Subscribe | 2008-01-09 |
| ➤ Subscribe | Topical Gel | 0.30% | ➤ Subscribe | 2009-09-15 |
| ➤ Subscribe | Gel | 0.1%/2.5% | ➤ Subscribe | 2011-12-30 |
| ➤ Subscribe | Topical Gel | 0.33% | ➤ Subscribe | 2014-12-15 |
| ➤ Subscribe | Gel | 0.3%/2.5% | ➤ Subscribe | 2016-05-04 |
| ➤ Subscribe | Spray | 0.05% | ➤ Subscribe | 2008-09-29 |
International Patents for Galderma Labs Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1716856 | ➤ Sign Up |
| Spain | 2391385 | ➤ Sign Up |
| Mexico | 2016000122 | ➤ Sign Up |
| Canada | 2567401 | ➤ Sign Up |
| Cyprus | 1116690 | ➤ Sign Up |
| South Africa | 201302859 | ➤ Sign Up |
| South Korea | 20060004667 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Galderma Labs Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C/GB01/003 | United Kingdom | ➤ Sign Up | PRODUCT 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/GB99/020 | United Kingdom | ➤ Sign Up | PRODUCT NAME: NEVIRAPINE = 11-CYCLOPROPYL-5,11-DIHYDRO-4-METHYL-6H-DIPYRIDO(3,2-B:2',3'-E)(1,4)DIAZEPIN-6-ONE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTERED: CH 54393 19971223; UK EU/1/97/055/001 19980205 |
| 2014 00036 | Denmark | ➤ Sign Up | PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130 |
| C/GB98/030 | United Kingdom | ➤ Sign Up | PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204 |
| 915 | Luxembourg | ➤ Sign Up | PRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 20150402 |
| C/GB05/030 | United Kingdom | ➤ Sign Up | PRODUCT 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 |
| /2014 | Austria | ➤ Sign Up | PRODUCT NAME: (1S)-1,5-ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY(PHENYL)METHYL)PHENYL)-D-GLUCITOL (EMPAGLIFLOZIN); REGISTRATION NO/DATE: EU/1/14/930 (MITTEILUNG) 20140527 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
Similar Applicant Names
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Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
