Details for New Drug Application (NDA): 204114
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NDA 204114 describes MEKINIST, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the MEKINIST profile page.
The generic ingredient in MEKINIST is trametinib dimethyl sulfoxide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the trametinib dimethyl sulfoxide profile page.
The generic ingredient in MEKINIST is trametinib dimethyl sulfoxide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the trametinib dimethyl sulfoxide profile page.
Summary for 204114
| Tradename: | MEKINIST |
| Applicant: | Novartis |
| Ingredient: | trametinib dimethyl sulfoxide |
| Patents: | 9 |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 204114
Generic Entry Date for 204114*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 204114
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 204114
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114 | NDA | Novartis Pharmaceuticals Corporation | 0078-0666 | 0078-0666-15 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0666-15) |
| MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114 | NDA | Novartis Pharmaceuticals Corporation | 0078-0668 | 0078-0668-15 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-0668-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.5MG | ||||
| Approval Date: | May 29, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 6, 2022 | ||||||||
| Regulatory Exclusivity Use: | ADDITION OF STUDY BRF117277, A NON-RANDOMIZED, OPEN-LABEL, MULTI-CENTER, MULTI-COHORT TRIAL OF DABRAFENIB PLUS TRAMETINIB IN SUBJECTS WITH BRAF MUTATION-POSITIVE MELANOMA THAT HAS METASTASIZED TO THE BRAIN | ||||||||
| Regulatory Exclusivity Expiration: | May 4, 2025 | ||||||||
| Regulatory Exclusivity Use: | TRAMETINIB AND DABRAFENIB IN COMBINATION, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS | ||||||||
| Regulatory Exclusivity Expiration: | Jun 22, 2024 | ||||||||
| Regulatory Exclusivity Use: | TRAMETINIB IN COMBINATION WITH DABRAFENIB, FOR THE TX. OF PTS WITH METASTATIC NON-SMALL CELL LUNG CANCERWITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST | ||||||||
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