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 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-eight supplementary protection certificates in eighteen countries.
Summary for GALDERMA LABS LP
| International Patents: | 421 |
| US Patents: | 60 |
| 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 | CAPEX | fluocinolone acetonide | SHAMPOO;TOPICAL | 020001-001 | Aug 27, 1990 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | |||||
| Galderma Labs Lp | DIFFERIN | adapalene | CREAM;TOPICAL | 020748-001 | May 26, 2000 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ||||
| Galderma Labs Lp | EPSOLAY | benzoyl peroxide | CREAM;TOPICAL | 214510-001 | Apr 22, 2022 | RX | Yes | Yes | 11,426,378 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | 8,080,530 | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | 9,782,425 | ⤷ Sign Up | ⤷ 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 LP
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 7,211,267 | ⤷ Sign Up |
| Galderma Labs Lp | DIFFERIN | adapalene | SOLUTION;TOPICAL | 020338-001 | May 31, 1996 | 4,717,720 | ⤷ Sign Up |
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | 7,964,202 | ⤷ Sign Up |
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | 8,241,649 | ⤷ Sign Up |
| Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 021789-001 | Jun 30, 2005 | 6,881,726 | ⤷ Sign Up |
| >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 | 0.33% | ➤ 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 |
| ➤ Subscribe | Topical Gel | 0.30% | ➤ Subscribe | 2009-09-15 |
| ➤ Subscribe | Gel | 0.1%/2.5% | ➤ Subscribe | 2011-12-30 |
International Patents for GALDERMA LABS LP Drugs
Supplementary Protection Certificates for GALDERMA LABS LP Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3170818 | 2020/035 | Ireland | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF (A) 3-(6-(1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5- YL)CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL)BENZOIC ACID (LUMACAFTOR) AND (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-QUINOLINE-3- CARBOXAMIDE (IVACAFTOR) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1059 20151124 |
| 1831149 | CA 2020 00027 | Denmark | ⤷ Sign Up | PRODUCT NAME: TRIFAROTEN, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: 61878 20200120; FIRST REG. NO/DATE: UK PL 10590/0071 20200113 |
| 1532149 | 8/2012 | Austria | ⤷ Sign Up | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION UND DESSEN SALZE, INSBES. LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 (MITTEILUNG) 20110830 |
| 2435024 | 2021C/518 | Belgium | ⤷ Sign Up | PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210 |
| 3170818 | 122020000044 | Germany | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AUS (A) 3-(6-(1-(2,2-DIFLUORBENZO(D)(1,3)DIOXOL-5-YL)CYCLOPROPAN-CARBOXAMIDO)-3-METHYLPYRIDIN-2-YL)BENZOESAEURE UND (B) N-(5-HYDROXY-2,4-DITERT-BUTYL-PHENYL)-4-OXO-1H-CHINOLIN-3-CARBOXAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1059 20151119 |
| >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.
