NATCO Pharma Limited is pleased to announce that its marketing and distribution partner Alvogen Pine Brook has received tentative approval for Abbreviated New Drug Application (ANDA).

The approval is for Ibrutinib tablets 560 mg, 420 mg, 280 mg and 140 mg strengths (generic for IMBRUVICA), from the US Food and Drug Administration (USFDA).

Based on 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 US $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 US $3 billion during the same period.