NATCO gets tentative US FDA approval for Ibrutinib tablets

NATCO Pharma is pleased to announce 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 US Food and Drug Administration (USFDA).

“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,” informed a company statement.

As per industry sales data, IMBRUVICA (Tablet and Capsule dosage forms) had generated annual sales of $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 $3.0 billion during the same period.