Sunday 18 April 2021
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business-standard - 11 days ago

Zydus Cadila receives USFDA approval for Ibrutinib Capsules

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.


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