Natco Pharma (NATCO), one of the few Indian companies to venture into new drug discovery research, on April 10 announced that its marketing and distribution partner Alvogen Pine Brook LLC, has received tentative approval for our Abbreviated New Drug Application (ANDA) for Ibrutinib Tablets 560mg, 420mg, 280mg and 140mg strengths (generic for IMBRUVICA), from the U.S. Food and Drug Administration (USFDA).

As per ANDA filing date and the approval timeline, NATCO believes that they are eligible for 180 days of sole generic marketing exclusivity for all the strengths of the tablet dosage form of the product at the time of launch.

As per industry sales data, IMBRUVICA (Tablet and Capsule dosage forms) had generated annual sales of USD 3.7 billion during the twelve months period ending December 2020 in the US market, of this, all the strengths of IMBRUVICA Tablets alone generated sales of USD 3 billion during the same period.

Shares of the company gained Rs 12.95, or 1.4%, to trade at  Rs 934.70.  The total volume of shares traded  was  25,110 at the BSE (11.18 a.m., Monday).