Details for New Drug Application (NDA): 217513
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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 217513
Tradename: | MEKINIST |
Applicant: | Novartis |
Ingredient: | trametinib dimethyl sulfoxide |
Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217513
Generic Entry Date for 217513*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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: 217513
Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 217513
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MEKINIST | trametinib dimethyl sulfoxide | SOLUTION;ORAL | 217513 | NDA | Novartis Pharmaceuticals Corporation | 0078-1161 | 0078-1161-47 | 90 mL in 1 BOTTLE (0078-1161-47) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 0.05MG BASE/ML | ||||
Approval Date: | Mar 16, 2023 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Mar 16, 2026 | ||||||||
Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
Regulatory Exclusivity Expiration: | Mar 16, 2030 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA (LGG) WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 29, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
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