Zydus Cadila has received final approval from the USFDA to market Ibrutinib Capsules, 70 mg and 140 mg (US RLD: Imbruvica Capsules). Ibrutinib belongs to a class of drugs known as kinase inhibitors and is used to treat certain cancers, such as mantle cell lymphoma or marginal zone lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, and Waldenstrom's macroglobulinemia.
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. Therefore, with this approval, Zydus is eligible for 180 days of generic drug exclusivity for Ibrutinib Capsules, 70 mg.
For Ibrutinib Capsules, 140 mg, the company will have 180-days of shared generic drug exclusivity. The 70 mg capsule has brand sales of USD 32.5 mn, while the 140 mg dose has brand sales of USD 745.9 mn. Zydus is the first company to receive approval for generic Ibrutinib 70 mg capsules.
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad. The group now has 313 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.
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