Details for New Drug Application (NDA): 213591
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NDA 213591 describes TABRECTA, which is a drug marketed by Novartis Pharm and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the TABRECTA profile page.
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.
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: | 10,596,178 | Patent Expiration: | Jul 22, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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