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Last Updated: January 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212725

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NDA 212725 describes ROZLYTREK, which is a drug marketed by Genentech Inc and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the ROZLYTREK profile page.

The generic ingredient in ROZLYTREK is entrectinib. One supplier is listed for this compound. Additional details are available on the entrectinib profile page.
Summary for 212725
Tradename:ROZLYTREK
Applicant:Genentech Inc
Ingredient:entrectinib
Patents:10
Generic Entry Opportunity Date for 212725
Generic Entry Date for 212725*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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.

Suppliers and Packaging for NDA: 212725
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROZLYTREK entrectinib CAPSULE;ORAL 212725 NDA Genentech Inc. 50242-091 50242-091-30 1 BOTTLE in 1 CARTON (50242-091-30) > 30 CAPSULE in 1 BOTTLE
ROZLYTREK entrectinib CAPSULE;ORAL 212725 NDA Genentech Inc. 50242-091 50242-091-86 1 BOTTLE in 1 CARTON (50242-091-86) > 30 CAPSULE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Aug 15, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 15, 2026
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS ARE ROS1-POSITIVE
Regulatory Exclusivity Expiration:Aug 15, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Feb 17, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER

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