Zydus Cadila announced on Thursday that USFDA has approved it to market Ibrutinib Capsules, 70 mg and 140 mg.
According to the USFDA letter, Zydus was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Ibrutinib capsules, 70 mg. for these capsules, the company will have 180 days of shared generic drug exclusivity. The 70 mg capsules have a brand sales of USD 32.5 mn, while 140 mg has a brand sales of USD 745.9 mn. Zydus is the first company to receive approval for generic Ibrutinib 70 mg capsules.
