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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 218550


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NDA 218550 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. One supplier is listed for this compound. Additional details are available on the entrectinib profile page.
Summary for 218550
Tradename:ROZLYTREK
Applicant:Genentech Inc
Ingredient:entrectinib
Patents:0
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218550
Generic Entry Date for 218550*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PEDIATRIC PATIENTS OLDER THAN 1 MONTH UP TO 12 YEARS OF AGE WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION, ARE METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY
Dosage:
PELLETS;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: 218550
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROZLYTREK entrectinib PELLETS;ORAL 218550 NDA Genentech, Inc. 50242-623 50242-623-42 42 DOSE PACK in 1 CARTON (50242-623-42) / 20 PELLET in 1 DOSE PACK (50242-623-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:PELLETS;ORALStrength50MG/PACKET
Approval Date:Oct 20, 2023TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 15, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Oct 20, 2026
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Oct 20, 2030
Regulatory Exclusivity Use:TREATMENT OF PEDIATRIC PATIENTS OLDER THAN 1 MONTH UP TO 12 YEARS OF AGE WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION, ARE METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY

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