Natco receives USFDA tentative approval for Ibrutinib Tablets

Natco Pharma announced that its marketing and distribution partner Alvogen Pine Brook LLC, has received tentative approval for its 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 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.

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