Zydus Wins USFDA’s Tentative Approval to Market Ibrutinib Tablets in US

Zydus Lifesciences said it has received tentative approval from the US Food and Drug Administration to sell Ibrutinib tablets in three strengths 140 mg, 280 mg, and 420 mg in the American market.

The drug is a generic version of Imbruvica and is used to treat a range of blood cancers, including chronic lymphocytic leukaemia, small lymphocytic lymphoma with a 17p deletion, and Waldenstrom’s macroglobulinemia.

The tablets will be produced at Zydus’ manufacturing site in Ahmedabad, Gujarat. Citing IQVIA data from May 2025, the company said the annual sales for Ibrutinib tablets in the US stood at about $2.15 billion. The approval is tentative, meaning Zydus cannot launch the product until exclusivity or patent protections on the original brand expire.

This development comes after a USFDA inspection at one of Zydus’ oncology facilities earlier this year. That inspection ended with two observations. The company clarified that neither was related to data integrity. In its most recent earnings, Zydus reported a net profit of ₹1,170.9 crore for the March quarter. That was lower than the same period last year. However, revenue rose 18% year-on-year to ₹6,527.9 crore.

Zydus Lifesciences shares have gained 0.96% closing at ₹971,15 on July 24, 2025. Zydus Lifesciences shares have dipped 17% in the last year, gained 1.21% in the year-to-date, and dipped 0.37% in the previous month.

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