Balversa - (3mg, 4mg and 5 mg; Tablet)

Generic Name	Erdafitinib	Innovator	Janssen Pharma
Dosage	3mg, 4mg and 5 mg; Tablet	Branded US Sales	Less Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	None	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma that has • susceptible FGFR3 or FGFR2 genetic alterations and • progressed during or following at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
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
*****	*** / *********	*** **, ****	*******	****	*** ****** *** ****

Chronology Of Events