NATCO Pharma Limited has 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).
NATCO Pharma said, “Based on our ANDA filing date and the approval timeline, NATCO believes that we 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 $3.7 billion during the twelve months ending December 2020 in the US market, of this, all the strengths of IMBRUVICA Tablets alone generated sales of $3.0 billion during the same period.
At around 10.49 am, Natco Pharma was trading at Rs938.35 per piece up by 1.80% on Sensex.
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( With inputs from indiainfoline)