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-six approved drugs.
There are sixty-one US patents protecting GALDERMA LABS LP drugs.
There are four hundred and twenty-one patent family members on GALDERMA LABS LP drugs in thirty-seven countries and one hundred and seventy-nine supplementary protection certificates in eighteen countries.
Summary for GALDERMA LABS LP
| International Patents: | 421 |
| US Patents: | 61 |
| Tradenames: | 18 |
| Ingredients: | 16 |
| NDAs: | 26 |
Drugs and US Patents for GALDERMA LABS LP
| 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 | AB | RX | Yes | Yes | 8,709,478 | ⤷ Subscribe | ⤷ Subscribe | |||
| Galderma Labs Lp | DESOWEN | desonide | CREAM;TOPICAL | 019048-001 | Dec 14, 1984 | AB | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ||||
| Galderma Labs Lp | EPSOLAY | benzoyl peroxide | CREAM;TOPICAL | 214510-001 | Apr 22, 2022 | RX | Yes | Yes | 10,933,046 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | 8,080,530 | ⤷ Subscribe | Y | ⤷ Subscribe | ||
| Galderma Labs Lp | CLOBEX | clobetasol propionate | SPRAY;TOPICAL | 021835-001 | Oct 27, 2005 | AT | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ||||
| Galderma Labs Lp | DIFFERIN | adapalene | CREAM;TOPICAL | 020748-001 | May 26, 2000 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ||||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | 8,093,219 | ⤷ Subscribe | Y | ⤷ Subscribe | ||
| >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 LP
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | 8,936,800 | ⤷ Subscribe |
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | 7,868,044 | ⤷ Subscribe |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 8,394,406 | ⤷ Subscribe |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 10,058,564 | ⤷ Subscribe |
| Galderma Labs Lp | CLOBEX | clobetasol propionate | SPRAY;TOPICAL | 021835-001 | Oct 27, 2005 | 5,972,920 | ⤷ Subscribe |
| Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 021789-001 | Jun 30, 2005 | 6,881,726 | ⤷ Subscribe |
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | 11,033,565 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for GALDERMA LABS LP drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ 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 | Spray | 0.05% | ➤ Subscribe | 2008-09-29 |
| ➤ 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 |
International Patents for GALDERMA LABS LP Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2012136952 | ⤷ Subscribe |
| Mexico | 2013013722 | ⤷ Subscribe |
| New Zealand | 716033 | ⤷ Subscribe |
| Denmark | 2388007 | ⤷ Subscribe |
| World Intellectual Property Organization (WIPO) | 2015006319 | ⤷ Subscribe |
| South Korea | 20130002338 | ⤷ Subscribe |
| Denmark | 2046318 | ⤷ Subscribe |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for GALDERMA LABS LP Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1284974 | 122008000011 | Germany | ⤷ Subscribe | PRODUCT NAME: 4,4-DIFLUORO-N-((1S)-3-((1R,3S,5S)-3-(3-METHYL-5-(PROPAN-2-YL)-4H-1,2,4-TRIAZOL-4-YL)-8-AZABICYCLO(3.2.1)OCTAN-8-YL)-1-PHENYLPROPYL)CYCLOHEXANECARBOXAMIDE; REGISTRATION NO/DATE: EU/1/07/418/001-010 20070918 |
| 2137537 | 122014000069 | Germany | ⤷ Subscribe | PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| 0281459 | SPC/GB99/001 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: CLOPIDOGREL HYDROGEN SULPHATE, THE DEXTROROTATORY ISOMER OF ALPHA-(4,5,6,7-TETRAHYDROTHIENO(3,2-C)PYRID-5-YL)(2-CHLOROPHENYL) METHYL ACETATE AS THE HYDROGEN SULPHATE SALT; REGISTERED: UK EU/1/98/069/001 19980715; UK EU/1/98/069/002 19980715; UK EU/1/98/069/003 19980715 |
| 1948158 | 2016C/026 | Belgium | ⤷ Subscribe | PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUMZOUT COMPLEX, I.E. TRINATRIUM (3-((1S,3R)-1-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONIL-1-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-METHYL-2'-(PENTANOYL(2-(TETRAZOL-5-YLATE)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT)HEMIPENTAHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123 |
| 2826776 | 301105 | Netherlands | ⤷ Subscribe | PRODUCT NAME: EEN COMBINATIE VAN (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUOR-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPAANCARBOXAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-FENYL)-4-OXO-1H-CHINOLINE-3-CARBOXAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1306 20181106 |
| 1631293 | 2014C/042 | Belgium | ⤷ Subscribe | PRODUCT NAME: MIRVASO (BRIMONIDINE) EN FARMACEUTISCHE ZOUTEN DAARVAN VOOR GEBRUIK ALS MEDICIJN VOOR HET BEHANDELEN VAN ROSACEA GEINDUCEERDE ROODHEID; AUTHORISATION NUMBER AND DATE: EU/1/13/904 20140221 |
| 0733366 | SPC/GB98/031 | United Kingdom | ⤷ Subscribe | PRODUCT NAME: 2-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL) BIPHENYL-4-YL)-METHYL)-5-(HYDROXYMETHYL)IMIDAZOLE (LOSARTAN),OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT( LOSARTAN POTASSIUM) AND HYDROCHLOROTHIAZIDE,; REGISTERED: FR 338520.7 19950215; FR 558453.7 19950215; UK 00025/0338 19960412 |
| >Patent Number | >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.
