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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-nine US patents protecting GALDERMA LABS drugs.
There are three hundred and eighty-seven patent family members on GALDERMA LABS drugs in thirty-five countries and one hundred and twelve supplementary protection certificates in sixteen countries.
Summary for Galderma Labs
| International Patents: | 387 |
| US Patents: | 69 |
| 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 | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | RX | Yes | Yes | 9,861,632 | Start Trial | Start Trial | ||||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | 8,080,530 | Start Trial | Y | Start Trial | ||
| Galderma Labs Lp | METROCREAM | metronidazole | CREAM;TOPICAL | 020531-001 | Sep 20, 1995 | AB | RX | Yes | Yes | Start Trial | Start Trial | ||||
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | RX | Yes | Yes | 8,163,725 | Start Trial | Y | Start Trial | |||
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | RX | Yes | Yes | 9,861,631 | Start Trial | Start Trial | ||||
| Galderma Labs Lp | TRI-LUMA | fluocinolone acetonide; hydroquinone; tretinoin | CREAM;TOPICAL | 021112-001 | Jan 18, 2002 | RX | Yes | Yes | 7,939,516 | Start Trial | Y | Start Trial | |||
| Galderma Labs Lp | TRI-LUMA | fluocinolone acetonide; hydroquinone; tretinoin | CREAM;TOPICAL | 021112-001 | Jan 18, 2002 | RX | Yes | Yes | 7,915,243 | Start Trial | Y | Start Trial | |||
| >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 | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | 4,717,720 | Start Trial |
| Galderma Labs Lp | DIFFERIN | adapalene | CREAM;TOPICAL | 020748-001 | May 26, 2000 | 4,717,720 | Start Trial |
| Galderma Labs | CLOBEX | clobetasol propionate | SHAMPOO;TOPICAL | 021644-001 | Feb 5, 2004 | 7,316,810 | Start Trial |
| Galderma Labs Lp | DIFFERIN | adapalene | SOLUTION;TOPICAL | 020338-001 | May 31, 1996 | 4,717,720 | Start Trial |
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | RE34440 | Start Trial |
| Galderma Labs Lp | CLOBEX | clobetasol propionate | SPRAY;TOPICAL | 021835-001 | Oct 27, 2005 | 5,990,100 | Start Trial |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 5,919,775 | Start Trial |
| >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 | 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 |
| ➤ 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 |
International Patents for Galderma Labs Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 60327745 | Start Trial |
| Cyprus | 1111095 | Start Trial |
| Poland | 378932 | Start Trial |
| Australia | 2014287422 | Start Trial |
| Russian Federation | 2016103715 | Start Trial |
| Russian Federation | 2633076 | Start Trial |
| Canada | 2466321 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Galderma Labs Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1948158 | 300810 | Netherlands | Start Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, IE. TRINATRIURA (3-((LS,3R)-L-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONYL-L-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-ETHYL-2'-(PENTANOYL(2"-(TETRAZOL-5-YLAAT)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT) HEMIPENTAHYDRAAT; REGISTRATION NO/DATE: EU/1/15/1058 (C(2015) 8288) 20151123 |
| 1631293 | 2014C/042 | Belgium | Start Trial | 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 |
| 1999109 | SPC/GB13/040 | United Kingdom | Start Trial | PRODUCT NAME: FLORBETAPIR (18F) ((E)-4-(2-(6-(2-(2-(2-((18F)-FLUOROETHOXY)ETHOXY)ETHOXY)PYRIDIN-3-YL)VINYL)-N-METHYL BENZENAMINE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY FLORBETAPIR (18F); REGISTERED: UK EU/1/12/805 20130117 |
| 1458369 | 08C0024 | France | Start Trial | PRODUCT NAME: ADAPALENE - PEROXYDE DE BENZOLE; REGISTRATION NO/DATE IN FRANCE: NL 33724 DU 20080123; REGISTRATION NO/DATE AT EEC: 40440 DU 20071218 |
| 2137537 | CA 2014 00035 | Denmark | Start Trial | PRODUCT NAME: DIMETHYL FUMARAT (DIMETHYLFUMARAT); REG. NO/DATE: EU/1/13/837/001-002 20140130 |
| 1631293 | C 2014 030 | Romania | Start Trial | PRODUCT NAME: BRIMONIDINA SI SARURILE FARMACEUTICE ALE ACESTEIA5-BROMO-N-(4,5-DIHIDRO-1-H-IMIDAZOL-2-IL)QUINOXALIN-6-AMINA; NATIONAL AUTHORISATION NUMBER: EU/1/13/904; DATE OF NATIONAL AUTHORISATION: 20140221; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/904; DATE OF FIRST AUTHORISATION IN EEA: 20140221 |
| 1131065 | 1490039-3 | Sweden | Start Trial | PRODUCT NAME: DIMETHYL FUMARATE; REG. NO/DATE: EU/1/13/837 20140130 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
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