US Patents With Foreign Priority to Patent: 17209098

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-001	Apr 12, 2019		RX	Yes	No						TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY, WITH DOSING BASED ON SERUM PHOSPHATE LEVELS
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-001	Apr 12, 2019		RX	Yes	No						TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS, AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY, WITH DOSING BASED ON SERUM PHOSPHATE LEVELS
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-002	Apr 12, 2019		RX	Yes	No						TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY, WITH DOSING BASED ON SERUM PHOSPHATE LEVELS
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-002	Apr 12, 2019		RX	Yes	No						TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 OR FGFR2 GENETIC ALTERATIONS, AND PROGRESSED DURING OR FOLLOWING PRIOR PLATINUM-CONTAINING CHEMOTHERAPY, WITH DOSING BASED ON SERUM PHOSPHATE LEVELS