Natco Pharma seeks USFDA nod for generic Erdafitinib Tablets

Hyderabad: NATCO Pharma Limited has announced the submission of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for the generic version of Erdafitinib Tablets 3 mg, 4 mg, and 5 mg strengths.

Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC). Erdafitinib Tablets are marketed in the United States (US) by Janssen Biotech under brand Balversa.

NATCO has been named as 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 stated.

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Balversa has recorded sales of USD 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.

Read also: Natco Pharma gets USFDA nod for Tipiracil Hydrochloride and Trifluridine Tablets

Natco Pharma Limited is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of finished dosage formulations (“FDF”) and active pharmaceutical ingredients (“APIs”). The company's focus is primarily on niche therapeutic areas and complex products. It markets and distributes products in over 40 countries. It sells FDF products in the United States, India, Europe and the rest of the world (“RoW”). Natco also operates in certain key geographies through its subsidiaries.

Natco Pharma is also engaged in contract manufacturing business, whereby it undertakes selected contracts with pharmaceutical companies to manufacture and supply pharmaceutical products.

Read also: Natco Pharma posts Rs 715.3 crore of Profit after tax for year ended March 31st, 2023

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