Zydus Cadila gets US FDA nod for Imbruvica generic

Indian drugmaker Zydus Cadila, part of Cadila Healthcare (BOM: 532321), has received final approval from the US Food and Drug Administration to market ibrutinib capsules, 70mg and 140mg, a generic of blockbuster cancer drug Imbruvica.

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.

The branded drug is marketed by Johnson & Johnson (NYSE: JNJ) and AbbVie (NYSE: ABBV). Global Imbruvica net revenues were $5.314 billion in full-year 2020, an increase of 13.7%, with US net revenues of $4.305 billion and international profit sharing of around $1 billion.