Ibrutinib

Overview

Ibrutinib is an orally administered small molecule that acts as a Bruton's tyrosine kinase (BTK) inhibitor, used primarily for the treatment of certain cancers of the blood and lymphatic system, such as chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). By inhibiting BTK, ibrutinib disrupts B-cell receptor signaling pathways essential for the survival and proliferation of malignant B cells.

API suppliers (5)

Suppliers of Ibrutinib backed by a verifiable FDA Type II Drug Master File. Source: FDA quarterly DMF list.

• Ono Pharmaceutical Co., Ltd.Japan2 active DMF
• WAVELENGTH ENTERPRISES LTDIsrael1 active DMF
• Alembic Pharmaceuticals LimitedIndia1 active DMF
• Cipla USA, Inc.USA
• FRESENIUS KABI ONCOLOGY LTD

Patent & exclusivity (US)

Per the FDA Orange Book (6 approved US products), the latest listed US patent on Ibrutinib expires 13 Jun 2039 and exclusivity 24 Feb 2030. Generic API sourcing typically opens up once these lapse.

Therapeutic areas