Zydus Lifesciences Limited has received tentative approval from the U.S. Food and Drug Administration (USFDA) to market Ibrutinib tablets in three strengths — 140 mg, 280 mg, and 420 mg. The approved products are generic versions of Imbruvica®, a widely used cancer medication in the United States.
Ibrutinib is a kinase inhibitor used in the treatment of adult patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) with 17p deletion, as well as Waldenstrom's Macroglobulinemia (WM).
The tablets will be manufactured at Zydus formulation facility located in the Special Economic Zone (SEZ) in Ahmedabad. According to IQVIA data (MAT May 2025), annual sales of Ibrutinib tablets in the U.S. stood at approximately USD 2.15 billion.
This latest approval brings Zydus’ total number of ANDA approvals to 420. Since the company began its filing process in the financial year 2003-04, it has submitted a total of 484 Abbreviated New Drug Applications (ANDAs).
Zydus continues to expand its footprint in the U.S. generics market, strengthening its portfolio in oncology and complex therapies.
