Details for New Drug Application (NDA): 212725
✉ Email this page to a colleague
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: | 14 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
Approval Date: | Aug 15, 2019 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Aug 15, 2026 | ||||||||
Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION, ARE METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE EITHER PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY | ||||||||
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 |
Complete Access Available with Subscription