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-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 | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | AB | RX | Yes | Yes | 8,080,537 | ⤷ Sign Up | ⤷ Sign Up | |||
| Galderma Labs | CLOBEX | clobetasol propionate | SHAMPOO;TOPICAL | 021644-001 | Feb 5, 2004 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ||||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | 8,093,219 | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Galderma Labs Lp | METROLOTION | metronidazole | LOTION;TOPICAL | 020901-001 | Nov 24, 1998 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ||||
| Galderma Labs Lp | SOOLANTRA | ivermectin | CREAM;TOPICAL | 206255-001 | Dec 19, 2014 | AB | RX | Yes | Yes | 8,815,816 | ⤷ 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 | CLOBEX | clobetasol propionate | SHAMPOO;TOPICAL | 021644-001 | Feb 5, 2004 | 7,700,081 | ⤷ Sign Up |
| Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 019737-001 | Nov 22, 1988 | 4,837,378 | ⤷ Sign Up |
| Galderma Labs Lp | DIFFERIN | adapalene | SOLUTION;TOPICAL | 020338-001 | May 31, 1996 | 4,717,720 | ⤷ Sign Up |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 8,394,405 | ⤷ 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 drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ 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 |
| ➤ Subscribe | Lotion | 0.05% | ➤ Subscribe | 2006-03-27 |
International Patents for GALDERMA LABS Drugs
Supplementary Protection Certificates for GALDERMA LABS Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1458369 | 132008901685368 | Italy | ⤷ Sign Up | PRODUCT NAME: ADAPALENE E BENZOILE PEROSSIDO(EPIDUO); AUTHORISATION NUMBER(S) AND DATE(S): 40440, 20071218;DA 038261018/M A 038261057/M, 20080618 |
| 0481754 | SPC/GB06/032 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ENTECAVIR-(2-AMINO-1,9-DIHYDRO-9-((1S,3R,4S)-4-HYDROXY-3-(HYDROXYMETHYL)-2-METHYLENE CYCLOPENTYL)-6H-PURIN-6-ONE AND HYDRATES THEREOF, PARTICULARLY THE MONOHYDRATE; REGISTERED: UK EU/1/06/343/001 20060626; UK EU/1/06/343/002 20060626; UK EU/1/06/343/003 20060626; UK EU/1/06/343/004 20060626; UK EU/1/06/343/005 20060626 |
| 0641330 | SPC/GB04/034 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: PREGABALIN (S-(+)-4-AMINO-3(2-METHYLPROPYL)BUTANOIC ACID) OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACTIVE SALT.; REGISTERED: UK EU/1/04/279/001 20040706; UK EU/1/04/279/002 20040706; UK EU/1/04/279/003 20040706; UK EU/1/04/279/004 20040706; UK EU/1/04/279/005 20040706; UK EU/1/04/279/006 20040706; UK EU/1/04/279/025 20040706; UK EU/1/04/279/019 20040706; UK EU/1/04/279/020 20040706; UK EU/1/04/279/021 20040706; UK EU/1/04/279/022 20040706; UK EU/1/04/279/023 20040706; UK EU/1/04/279/024 20040706; UK EU/1/04/279/013 20040706; UK EU/1/04/279/014 20040706; UK EU/1/04/279/015 20040706; UK EU/1/04/279/016 20040706; UK EU/1/04/279/017 20040706; UK EU/1/04/279/018 20040706; UK EU/ |
| 2826776 | CA 2021 00013 | Denmark | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF (A) (R)-1-(2,2-DIFLUOROBENZO(D)(1,3)DIOXOL-5-YL)-N-(1-(2,3-DIHYDROXYPROPYL)-6-FLUORO-2-(1-HYDROXY-2-METHYLPROPAN-2-YL)-1H-INDOL-5-YL)CYCLOPROPANECARBOXAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) ....; REG. NO/DATE: EU/1/18/1306 20181106 |
| 1458369 | CA 2008 00029 | Denmark | ⤷ Sign Up | PRODUCT NAME: ADAPALEN, BENZOYLPEROXID |
| >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.
