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Generated: April 24, 2019

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Details for New Drug Application (NDA): 210861

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NDA 210861 describes VITRAKVI, which is a drug marketed by Bayer Hlthcare and Bayer Healthcare and is included in two NDAs. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the VITRAKVI profile page.

The generic ingredient in VITRAKVI is larotrectinib. One supplier is listed for this compound. Additional details are available on the larotrectinib profile page.
Summary for 210861
Tradename:VITRAKVI
Applicant:Bayer Hlthcare
Ingredient:larotrectinib
Patents:8
Generic Entry Opportunity Date for 210861
Generic Entry Date for 210861*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH SOLID TUMORS THAT HAVE NO SATISFACTORY ALTERNATIVE TREATMENTS OR THAT HAVE PROGRESSED FOLLOWING TREATMENT
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: 210861
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VITRAKVI larotrectinib CAPSULE;ORAL 210861 NDA Loxo Oncology, Inc. 71777-390 71777-390-01 60 CAPSULE in 1 BOTTLE (71777-390-01)
VITRAKVI larotrectinib CAPSULE;ORAL 210861 NDA Loxo Oncology, Inc. 71777-391 71777-391-01 60 CAPSULE in 1 BOTTLE (71777-391-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Nov 26, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 26, 2025
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH SOLID TUMORS THAT ARE METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY
Regulatory Exclusivity Expiration:Nov 26, 2025
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC RECEPTOR TYROSINE KINASE (NTRK) GENE FUSION WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION
Regulatory Exclusivity Expiration:Nov 26, 2025
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH SOLID TUMORS THAT HAVE NO SATISFACTORY ALTERNATIVE TREATMENTS OR THAT HAVE PROGRESSED FOLLOWING TREATMENT

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