Pharsight

Balversa is owned by Janssen Biotech.

Balversa contains Erdafitinib.

Balversa has a total of 5 drug patents out of which 0 drug patents have expired.

Balversa was authorised for market use on 12 April, 2019.

Balversa is available in tablet;oral dosage forms.

Balversa can be used as 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, treatment of adults with locally advanced or metastatic urothelial carcinoma that has susceptible fgfr3 or fgfr2 genetic alterations and progressed during or following prior platinum-containing chemotherapy, treatment of adults with locally advanced or metastatic, surgically unresectable urothelial carcinoma that has susceptible fgfr3 or fgfr2 genetic alterations and progressed during or following prior platinum-containing chemotherapy; treatment of adults with metastatic urothelial carcinoma that has susceptible fgfr3 or fgfr2 genetic alterations and progressed during or following prior platinum-containing chemotherapy; treatment of adults with locally advanced or metastatic urothelial carcinoma that has susceptible fgfr3 genetic alterations and progressed during or following prior platinum-containing chemotherapy; treatment of adults with locally advanced or metastatic urothelial carcinoma that has susceptible fgfr3 or fgfr2 genetic alterations and progressed during or following prior platinum-containing chemotherapy.

Drug patent challenges can be filed against Balversa from April, 2023.

The generics of Balversa are possible to be released after 02 February, 2038.

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8895601	JANSSEN BIOTECH	Pyrazolyl quinoxaline kinase inhibitors	May, 2031 (8 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9464071	JANSSEN BIOTECH	Pyrazolyl quinoxaline kinase inhibitors	Apr, 2031 (8 years from now)
US9902714	JANSSEN BIOTECH	Quinoxaline derivatives useful as FGFR kinase modulators	Mar, 2035 (12 years from now)
US10898482	JANSSEN BIOTECH	Pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N'-1 methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine	Feb, 2036 (13 years from now)
US11077106	JANSSEN BIOTECH	Cancer treatment	Feb, 2038 (15 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Apr 12, 2024

Drugs and Companies using ERDAFITINIB ingredient

NCE-1 date: April, 2023

Market Authorisation Date: 12 April, 2019

Treatment: Treatment of adults with locally advanced or metastatic urothelial carcinoma that has susceptible fgfr3 or fgfr2 genetic alterations and progressed during or following prior platinum-containing chemotherapy; Treatment of adults with locally advanced or metastatic, surgically unresectable urothelial carcinoma that has susceptible fgfr3 or fgfr2 genetic alterations and progressed during or following prior platinum-containing chemotherapy; Treatment of adults with metastatic urothelial carcinoma that has susceptible fgfr3 or fgfr2 genetic alterations and progressed during or following prior platinum-containing chemotherapy; Treatment of adults with locally advanced or metastatic urothelial carcinoma that has susceptible fgfr3 genetic alterations and progressed during or following prior platinum-containing chemotherapy; 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

Dosage: TABLET;ORAL