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Galderma Labs Lp Company Profile
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-three approved drugs.
There are sixty US patents protecting GALDERMA LABS LP drugs.
There are three hundred and forty patent family members on GALDERMA LABS LP drugs in thirty-three countries and ninety-eight supplementary protection certificates in fifteen countries.
Summary for Galderma Labs Lp
| International Patents: | 340 |
| US Patents: | 60 |
| Tradenames: | 15 |
| Ingredients: | 13 |
| NDAs: | 23 |
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 | CLOBEX | clobetasol propionate | LOTION;TOPICAL | 021535-001 | Jul 24, 2003 | AB | 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 | 8,241,649 | ➤ Sign Up | Y | ➤ Sign Up | ||
| Galderma Labs Lp | TRI-LUMA | fluocinolone acetonide; hydroquinone; tretinoin | CREAM;TOPICAL | 021112-001 | Jan 18, 2002 | RX | Yes | Yes | 8,653,053 | ➤ Sign Up | Y | ➤ Sign Up | |||
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | RX | Yes | Yes | 9,241,946 | ➤ Sign Up | ➤ Sign Up | ||||
| Galderma Labs Lp | PERIOSTAT | doxycycline hyclate | TABLET;ORAL | 050783-001 | Feb 2, 2001 | DISCN | Yes | No | ➤ 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 | CLOBEX | clobetasol propionate | SPRAY;TOPICAL | 021835-001 | Oct 27, 2005 | 5,972,920 | ➤ Sign Up |
| Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 019737-001 | Nov 22, 1988 | 4,837,378 | ➤ Sign Up |
| Galderma Labs Lp | METVIXIA | methyl aminolevulinate hydrochloride | CREAM;TOPICAL | 021415-001 | Jul 27, 2004 | 6,034,267 | ➤ Sign Up |
| Galderma Labs Lp | ORACEA | doxycycline | CAPSULE;ORAL | 050805-001 | May 26, 2006 | 5,789,395 | ➤ Sign Up |
| Galderma Labs Lp | DIFFERIN | adapalene | CREAM;TOPICAL | 020748-001 | May 26, 2000 | RE34440 | ➤ 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 | 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 |
| ➤ Subscribe | Spray | 0.05% | ➤ Subscribe | 2008-09-29 |
Non-Orange Book US Patents for Galderma Labs Lp
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 8,993,571 | Compounds, formulations, and methods for treating or preventing inflammatory skin disorders | ➤ Sign Up |
| 8,729,127 | Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders | ➤ Sign Up |
| 7,838,563 | Compounds, formulations, and methods for ameliorating telangiectasias | ➤ Sign Up |
| 8,557,817 | Compounds, formulations, and methods for treating or preventing inflammatory skin disorders | ➤ Sign Up |
| 5,886,038 | Composition and method for treatment of psoriasis | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
International Patents for Galderma Labs Lp Drugs
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2016526572 | ➤ Sign Up |
| Austria | 516037 | ➤ Sign Up |
| South Korea | 101257046 | ➤ Sign Up |
| Hungary | 0500006 | ➤ Sign Up |
| Australia | 2008209730 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for Galderma Labs Lp Drugs
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 1 5019-2014 | Slovakia | ➤ Sign Up | PRODUCT NAME: BRIMONIDIN; REGISTRATION NO/DATE: EU/1/13/904/001 - EU/1/13/904/003 20140221 |
| 16/018 | Ireland | ➤ Sign Up | PRODUCT NAME: 3-(6-((1-(2,2-DIFLUORO-1,3-BENZODIOXOL-5- YL)CYCLOPROPANECARBONYL)AMINO)-3-METHYLPYRIDIN-2-YL)BENZOIC ACID (LUMACAFTOR), OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR AN ESTER PRODRUG THEREOF; REGISTRATION NO/DATE: EU/1/15/1059 20151119 |
| 12/024 | Ireland | ➤ Sign Up | PRODUCT NAME: ETHYL 3-((2-(4-(HEXYLOXYCARBONYLAMINO-IMINO-METHYL)-PHENYLAMINO)- METHYL-1-METHYL-1H-BENZIMIDAZOL-5-CARBONYL)-PYRIDIN-2-YL-AMINO)-PROPIONATE METHANESULPHONATE; REGISTRATION NO/DATE: EU/1/08/442/001-EU/1/08/442/008 20080318 |
| 01C/040 | Belgium | ➤ Sign Up | PRODUCT NAME: MONOHYDRATE DU CHLORHYDRATE DE N,N-DIMETHYL-1-4-CHLOROPHENYL)CYCLOBUTYL-3-METHYLBUTYLAMINE ET COMPOSITIONS PHARMACEUTIQUES LE CONTENANT; NAT. REGISTRTION NO/DATE: 479 IS 52 F 5 20010425; FIRST REGISTRATION: CH 54770 19990113 |
| 2014024 | Lithuania | ➤ Sign Up | PRODUCT NAME: DIMETHYLIS FUMARAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.
