Natco Pharma filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the US Food and Drug Administration (FDA) for the generic version of erdafitinib tablets.
Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma. Erdafitinib tablets are marketed in the US by Janssen Biotech under the brand Balversa.
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Hyderabad-based Natco Pharma has been named defendant in a lawsuit filed in the US district court of New Jersey by Janssen Pharmaceutica NV, Janssen Biotech Inc, and Otsuka Holdings Co’s Astex Therapeutics Ltd.
“Natco believes that the ANDA is possibly sole first-to-file based on its filing date and may be eligible for 180 days of marketing exclusivity at the time of launch,’‘ the company said in a release.
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Balversa has recorded sales of $36.5 million in the US market for the year ending December 2022, as per IQVIA database.
Balversa is a registered trademark of the Janssen group of companies.