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-one US patents protecting GALDERMA LABS drugs.
There are four hundred and twenty-one 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: | 421 |
| US Patents: | 61 |
| 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 | 9,084,778 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Galderma Labs Lp | DIFFERIN | adapalene | LOTION;TOPICAL | 022502-001 | Mar 17, 2010 | DISCN | Yes | No | 8,435,502 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Galderma Labs Lp | TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902-001 | Jul 26, 2021 | RX | Yes | Yes | 9,868,103 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Galderma Labs Lp | TRI-LUMA | fluocinolone acetonide; hydroquinone; tretinoin | CREAM;TOPICAL | 021112-001 | Jan 18, 2002 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | |||||
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | AB | RX | Yes | Yes | 7,964,202 | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Galderma Labs Lp | AKLIEF | trifarotene | CREAM;TOPICAL | 211527-001 | Oct 4, 2019 | RX | Yes | Yes | 8,470,871 | ⤷ Sign Up | ⤷ Sign Up | ||||
| Galderma Labs Lp | TWYNEO | benzoyl peroxide; tretinoin | CREAM;TOPICAL | 214902-001 | Jul 26, 2021 | RX | Yes | Yes | 8,617,580 | ⤷ Sign Up | Y | ⤷ 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | CLOBEX | clobetasol propionate | SPRAY;TOPICAL | 021835-001 | Oct 27, 2005 | 5,990,100 | ⤷ Sign Up |
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | 8,703,820 | ⤷ Sign Up |
| Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 021789-001 | Jun 30, 2005 | 7,348,317 | ⤷ Sign Up |
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | 8,093,219 | ⤷ Sign Up |
| Galderma Labs Lp | DIFFERIN | adapalene | GEL;TOPICAL | 021753-001 | Jun 19, 2007 | 7,868,044 | ⤷ Sign Up |
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | 8,080,530 | ⤷ Sign Up |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 5,789,395 | ⤷ Sign Up |
| >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
Supplementary Protection Certificates for Galderma Labs Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 1831149 | 20C1025 | France | ⤷ Sign Up | PRODUCT NAME: TRIFAROTENE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; NAT. REGISTRATION NO/DATE: CIS 6 363 190 8 20200217; FIRST REGISTRATION: GB - PL 10590/0071 20200113 |
| 0252504 | C960032 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ACIDUM IBANDRONICUM, DESGEWENST IN DE VORM VAN EEN FARMACOLO- GISCH AANVAARDBAAR ZOUT OF IN DE VORM VAN EEN ESTER MET METHANOL,ETHANOL,2-PROPANOL OF 2-METHYLPROPANOL, OF IN DE VORM VEN EEN HYDRAAT,I.H.B.MONONATRIUM IBANDRONAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/96/012/001 19960625 |
| 1948158 | 16C0018 | France | ⤷ Sign Up | PRODUCT NAME: SACUBITRIL/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'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123 |
| 1831149 | CR 2020 00027 | Denmark | ⤷ Sign Up | PRODUCT NAME: TRIFAROTEN, EVENTUELT I FORM AF ET SALT DERAF; NAT. REG. NO/DATE: 61878 20200120; FIRST REG. NO/DATE: UK PL 10590/0071 20200113 |
| 2435024 | 132021000000095 | Italy | ⤷ Sign Up | PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210 |
| 1831149 | 2020C/525 | Belgium | ⤷ Sign Up | PRODUCT NAME: TRIFAROTEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; AUTHORISATION NUMBER AND DATE: BE554133 20200224 |
| >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.
Here is a list of applicants with similar names.
