Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
Harvard Business School
Boehringer Ingelheim
Mallinckrodt
Medtronic

Last Updated: December 7, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211710

See Plans and Pricing

« Back to Dashboard

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 twelve 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.
Summary for 211710
Tradename:VITRAKVI
Applicant:Bayer Healthcare
Ingredient:larotrectinib sulfate
Patents:11
Generic Entry Opportunity 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.

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 Loxo Oncology, Inc. 71777-392 71777-392-01 100 mL in 1 BOTTLE (71777-392-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 20MG BASE/ML
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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
Colorcon
Mallinckrodt
Express Scripts
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.