Vitrakvi - (25 mg and 100 mg ; Capsule)

Generic Name	Larotrectinib Sulfate	Innovator	Bayer
Dosage	25 mg and 100 mg ; Capsule	Branded US Sales	Less Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	Less Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	VITRAKVI is a kinase inhibitor 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,  are metastatic or where surgical resection is likely to result in severe morbidity, and  have no satisfactory alternative treatments or that have progressed following treatment.
Complexities	Yes

Executive Summary

Patent Status

Launch Timelines and Competition

Company	FTF Status / 180 days exclusivity	30-Months stay	Current Litigation Status	Current Approval Status	Likelihood of launch
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Chronology Of Events

Vitrakvi - (20MG/1ML)

Generic Name	Larotrectinib Sulfate	Innovator	None
Dosage	20MG/1ML	Branded US Sales	Less Than $1000 mn
Probable FTF	None	Known Para IV Filers	None
Other ANDA developers	None	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	VITRAKVI is a kinase inhibitor 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,  are metastatic or where surgical resection is likely to result in severe morbidity, and  have no satisfactory alternative treatments or that have progressed following treatment.
Complexities	Yes

Executive Summary

Patent Status

Chronology Of Events