Details for New Drug Application (NDA): 211710
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NDA 211710 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 twenty patents protecting this drug. Additional details are available on the VITRAKVI profile page.
The generic ingredient in VITRAKVI is larotrectinib sulfate. There is one drug master file entry for this compound. 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. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the larotrectinib sulfate profile page.
Summary for 211710
| Tradename: | VITRAKVI |
| Applicant: | Bayer Healthcare |
| Ingredient: | larotrectinib sulfate |
| Patents: | 18 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211710
Generic Entry Date for 211710*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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: 211710
| Mechanism of Action | Tropomyosin Receptor Kinases Inhibitors |
Suppliers and Packaging for NDA: 211710
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VITRAKVI | larotrectinib sulfate | SOLUTION;ORAL | 211710 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-392 | 50419-392-01 | 100 mL in 1 BOTTLE (50419-392-01) |
| VITRAKVI | larotrectinib sulfate | SOLUTION;ORAL | 211710 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-393 | 50419-393-03 | 2 BOTTLE in 1 CARTON (50419-393-03) / 50 mL in 1 BOTTLE (50419-393-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 20MG BASE/ML | ||||
| Approval Date: | Nov 26, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 21, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING NEUROBLASTOMA, GLIOMA, THYROID, AND BREAST CANCER SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 4, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING CMN, IFS, HGG, DIPGS, PTC, SOFT TISSUE SARCOMA, AND SPINDLE CELL SARCOMA SOLID TUMORS EXHIBITING AN NTRK GENE FUSION IN A PEDIATRIC PATIENT WITH AN ORAL SOLUTION | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 21, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION AFTER SURGICAL RESECTION | ||||||||
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