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 two NDAs. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the ROZLYTREK profile page.
The generic ingredient in ROZLYTREK is entrectinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the entrectinib profile page.
The generic ingredient in ROZLYTREK is entrectinib. There is one drug master file entry for this compound. 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: | Oct 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
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