Natco Pharma announced that it has received tentative approval for Ibrutinib tablets (generic for IMBRUVICA) ANDA in the US market.
Natco Pharma announced on Saturday, 10 April 2021 that its 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).
Shares of Natco Pharma rose 1.53% to settle at Rs 921.75 on Friday, 9 April 2021.
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 billion during the same period.
Natco Pharma manufactures a comprehensive range of branded and generic dosage forms, bulk actives and intermediates for both Indian as well as International markets.
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