Galderma Labs Company Profile
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What is the competitive landscape for GALDERMA LABS, and when can generic versions of GALDERMA LABS drugs launch?
GALDERMA LABS has twenty-eight approved drugs.
There are sixty-six US patents protecting GALDERMA LABS drugs.
There are four hundred and twenty-eight patent family members on GALDERMA LABS drugs in thirty-seven countries and one hundred and seventy-one supplementary protection certificates in eighteen countries.
Summary for Galderma Labs
| International Patents: | 428 |
| US Patents: | 66 |
| Tradenames: | 19 |
| Ingredients: | 16 |
| NDAs: | 28 |
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 | DIFFERIN | adapalene | GEL;TOPICAL | 020380-002 | Jul 8, 2016 | OTC | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | |||||
| Galderma Labs Lp | EPSOLAY | benzoyl peroxide | CREAM;TOPICAL | 214510-001 | Apr 22, 2022 | RX | Yes | Yes | 11,541,026 | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | RX | Yes | Yes | 8,206,740 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | 7,550,440 | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Galderma Labs Lp | TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902-001 | Jul 26, 2021 | RX | Yes | Yes | 11,071,878 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Galderma Labs Lp | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | AB | RX | Yes | Yes | 8,426,410 | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | 8,093,219 | ⤷ Try a Trial | Y | ⤷ Try a 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 | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 9,241,946 | ⤷ Try a Trial |
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | 8,936,800 | ⤷ Try a Trial |
| Galderma Labs | CLOBEX | clobetasol propionate | SHAMPOO;TOPICAL | 021644-001 | Feb 5, 2004 | 7,700,081 | ⤷ Try a Trial |
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | RE34440 | ⤷ Try a Trial |
| Galderma Labs Lp | DIFFERIN | adapalene | CREAM;TOPICAL | 020748-001 | May 26, 2000 | 4,717,720 | ⤷ Try a Trial |
| Galderma Labs | CLOBEX | clobetasol propionate | SHAMPOO;TOPICAL | 021644-001 | Feb 5, 2004 | 8,066,975 | ⤷ Try a Trial |
| Galderma Labs | EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917-001 | Jul 15, 2015 | 8,445,543 | ⤷ Try a 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 | 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 |
| ➤ 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 |
International Patents for Galderma Labs Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Slovenia | 1562531 | ⤷ Try a Trial |
| Australia | 2006290364 | ⤷ Try a Trial |
| Brazil | 112016000335 | ⤷ Try a Trial |
| Slovenia | 2450035 | ⤷ Try a Trial |
| Japan | 6185536 | ⤷ Try a Trial |
| Cyprus | 1112721 | ⤷ Try a Trial |
| Denmark | 2046318 | ⤷ Try a Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Galderma Labs Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0137963 | 97C0042 | Belgium | ⤷ Try a Trial | PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121 |
| 2137537 | C300674 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| 0281459 | SPC/GB99/001 | United Kingdom | ⤷ Try a Trial | 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 |
| 1620113 | PA2015033,C1620113 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: IVERMEKTINAS; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402 |
| 1831149 | C01831149/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: TRIFAROTEN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67632 17.12.2020 |
| 0579826 | SPC/GB02/042 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422 |
| 1948158 | 93075 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN, C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3'-METHYL-2-(PENTANYOL(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE) DE TRISODIUM HEMIPENTAHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
