Details for New Drug Application (NDA): 213591
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The generic ingredient in TABRECTA is capmatinib hydrochloride. One supplier is listed for this compound. Additional details are available on the capmatinib hydrochloride profile page.
Summary for 213591
Tradename: | TABRECTA |
Applicant: | Novartis Pharm |
Ingredient: | capmatinib hydrochloride |
Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213591
Generic Entry Date for 213591*:
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: 213591
Suppliers and Packaging for NDA: 213591
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TABRECTA | capmatinib hydrochloride | TABLET;ORAL | 213591 | NDA | Novartis Pharmaceuticals Corporation | 0078-0709 | 0078-0709-56 | 56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-56) |
TABRECTA | capmatinib hydrochloride | TABLET;ORAL | 213591 | NDA | Novartis Pharmaceuticals Corporation | 0078-0709 | 0078-0709-94 | 56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-94) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 150MG BASE | ||||
Approval Date: | May 6, 2020 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | May 6, 2027 | ||||||||
Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE A MUTATION THAT LEADS TO MESENCHYMAL-EPITHELIAL TRANSITION (MET) EXON 14 SKIPPING AS DETECTED BY AN FDA-APPROVED TEST | ||||||||
Regulatory Exclusivity Expiration: | May 6, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 22, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
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