Details for New Drug Application (NDA): 218550
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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: | RX | Dosage: | PELLETS;ORAL | Strength | 50MG/PACKET | ||||
Approval Date: | Oct 20, 2023 | TE: | 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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