NATCO and Alvogen file ANDA for Ibrutinib Tablets for the USA market

Deepthi | Myequity news | Date : 31-01-2019 11:55:00 IST

Natco Pharma Limited submitted an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for generic version of Ibrutinib Tablets of 140mg, 280mg, 420mg and 560mg strength (proposed generic equivalents to Imbruvica® Tablets).

NATCO and its co-development & 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.

In the United States Imbruvica® brand is owned and marketed by Pharmacyclics LLC and Janssen Biotech, Inc. Imbruvica® had U.S. Sales of approximately US$ 2.6 Billion for twelve months ending September, 2018, according to data from IQVIA.

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