Natco Pharma submits new drug application with USFDA for generic Ibrutinib tablets

Natco has submitted the application with the US Food and Drug Administration(USFDA) for a generic version of Ibrutinib tablets in the strengths of 140 mg, 280 mg, 420 mg and 560 mg. The tablets would be generic equivalents to Imbruvica tablets.

New Delhi: Natco pharma Thursday said it has submitted an abbreviated new drug application(ANDA) with the US health regulator for a generic version of Ibrutinib tablets used for treating certain cancers. Natco said the company and its co-development and marketing partner Alvogen Pine Brook LLC, USA, believe that the ANDA is possibly sole first-to-file based on the ANDA filing dates.

"We further believe that our ANDA may be eligible for 180 days of marketing exclusivity at the time of potential launch of the product under certain circumstances," Natco Pharma said in a BSE filing.

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Natco has submitted the application with the US Food and Drug Administration(USFDA) for a generic version of Ibrutinib tablets in the strengths of 140 mg, 280 mg, 420 mg and 560 mg. The tablets would be generic equivalents to Imbruvica tablets.

In the US, Imbruvica brand is owned and marketed by Pharmacyclics LLC and Janssen Biotech Inc. "Imbruvica had US sales of approximately USD 2.6 billion for twelve months ended September 2018, according to data from IQVIA," the company said.

"As per the last tracked prescription sales, almost 83 per cent of the sales contribution has come from the above-mentioned tablet dosage forms," it added.

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