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 fifty-eight US patents protecting GALDERMA LABS drugs.
There are four hundred and five patent family members on GALDERMA LABS drugs in thirty-seven countries and one hundred and seventy-eight supplementary protection certificates in eighteen countries.
Summary for Galderma Labs
| International Patents: | 405 |
| US Patents: | 58 |
| 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 | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | 9,498,465 | ⤷ Try a Trial | Y | ⤷ 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 | ||
| Galderma Labs Lp | TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902-001 | Jul 26, 2021 | RX | Yes | Yes | 9,868,103 | ⤷ 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 | MIRVASO | brimonidine tartrate | GEL;TOPICAL | 204708-001 | Aug 23, 2013 | AB | RX | Yes | Yes | 8,053,427 | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Galderma Labs Lp | EPSOLAY | benzoyl peroxide | CREAM;TOPICAL | 214510-001 | Apr 22, 2022 | RX | Yes | Yes | 9,868,103 | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | RX | Yes | Yes | 8,470,364 | ⤷ 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 | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | 8,415,311 | ⤷ Try a Trial |
| Galderma Labs Lp | TRI-LUMA | fluocinolone acetonide; hydroquinone; tretinoin | CREAM;TOPICAL | 021112-001 | Jan 18, 2002 | 8,653,053 | ⤷ Try a Trial |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 8,709,478 | ⤷ Try a Trial |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 8,603,506 | ⤷ Try a Trial |
| Galderma Labs | EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917-001 | Jul 15, 2015 | 9,387,187 | ⤷ Try a Trial |
| Galderma Labs | EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917-001 | Jul 15, 2015 | 8,936,800 | ⤷ Try a Trial |
| Galderma Labs | EPIDUO FORTE | adapalene; benzoyl peroxide | GEL;TOPICAL | 207917-001 | Jul 15, 2015 | 8,729,127 | ⤷ 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 | 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 |
| ➤ Subscribe | Topical Gel | 0.33% | ➤ Subscribe | 2014-12-15 |
International Patents for Galderma Labs Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1114473 | ⤷ Try a Trial |
| Mexico | PA04008684 | ⤷ Try a Trial |
| Japan | 6271527 | ⤷ Try a Trial |
| South Korea | 20070087626 | ⤷ Try a Trial |
| Japan | 4955543 | ⤷ Try a Trial |
| Japan | 2013213063 | ⤷ Try a Trial |
| Russian Federation | 2004122429 | ⤷ 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 |
|---|---|---|---|---|
| 0253310 | SPC/GB95/010 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215 |
| 1458369 | CA 2008 00029 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ADAPALEN, BENZOYLPEROXID |
| 2826776 | 13/2021 | Austria | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON (A) (R)-1-(2,2-DIFLUORBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUOR-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL) CYCLOPROPANCARBOXAMID UND (B) N-(5-HYDROXY-2,4-DI-TERT-BUTYLPHENYL)-4-OXO-1H-CHINOLIN-3-CARBOXAMID; REGISTRATION NO/DATE: EU/1/18/1306 (MITTEILUNG) 20181106 |
| 1831149 | C202030025 | Spain | ⤷ Try a Trial | PRODUCT NAME: TRIFAROTENO, OPCIONALMENT EN FORMA DE UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: 85017-SE/H/1863/001/DC; DATE OF AUTHORISATION: 20200417; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): PL 10590/0071 -0001; DATE OF FIRST AUTHORISATION IN EEA: 20200113 |
| 1586316 | SPC/GB11/054 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523 |
| 1620113 | CA 2015 00045 | Denmark | ⤷ Try a Trial | PRODUCT NAME: IVERMECTIN, 22, 23-DIHYDROAVERMECTINB1A + 22,23-DIHRODROAVERMECTIN B1B FOR USE IN THE TREATMNET OF RESACEA; NAT. REG. NO/DATE: 54123 20150422; FIRST REG. NO/DATE: MT MA 117/01101 20150402 |
| 2340828 | LUC00195 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)-BIPHENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
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