Natco Pharma gets USFDA nod for Ibrutinib tablets in US
Hyderabad: Drugmaker, NATCO Pharma Limited, has recently announced that the company's marketing and distribution partner Alvogen Pine Brook LLC, has received tentative approval for 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).
Based on ANDA filing date and the approval timeline, NATCO believes that it is 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 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.
The Company has seven manufacturing facilities spread across India with modern research laboratories, capabilities in New Drug Development, etc.