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 two suppliers. There are eighteen patents protecting this drug. Additional details are available on the VITRAKVI profile page.
The generic ingredient in VITRAKVI is larotrectinib sulfate. Two suppliers are listed for this compound. Additional details are available on the larotrectinib sulfate profile page.
The generic ingredient in VITRAKVI is larotrectinib sulfate. Two suppliers are listed for this compound. Additional details are available on the larotrectinib sulfate profile page.
Summary for 210861
| Tradename: | VITRAKVI |
| Applicant: | Bayer Hlthcare |
| Ingredient: | larotrectinib sulfate |
| Patents: | 13 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210861
Generic Entry Date for 210861*:
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.
Pharmacology for NDA: 210861
| Mechanism of Action | Tropomyosin Receptor Kinases Inhibitors |
Suppliers and Packaging for NDA: 210861
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VITRAKVI | larotrectinib sulfate | CAPSULE;ORAL | 210861 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-390 | 50419-390-01 | 60 CAPSULE in 1 BOTTLE (50419-390-01) |
| VITRAKVI | larotrectinib sulfate | CAPSULE;ORAL | 210861 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-391 | 50419-391-01 | 60 CAPSULE in 1 BOTTLE (50419-391-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Nov 26, 2018 | TE: | 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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