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 (16)

Suppliers of Ibrutinib evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.

• Wisdom Pharmaceutical Co., LtdChina2 active DMF
• WAVELENGTH ENTERPRISES LTDIsrael1 active DMF GMP on record
• SCINOPHARM TAIWAN LTDTaiwan1 active DMF
• TAPI NL BVNetherlands1 active DMF
• ESTEVE HUAYI PHARMACEUTICAL CO LTDChina1 active DMF
• DR REDDYS LABORATORIES LTD1 active DMF GMP on record
• AARTI PHARMALABS LIMITEDIndia1 active DMF
• Zhejiang Ausun Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• SHILPA PHARMA LIFESCIENCES LTDIndia1 active DMF
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• BEIJING HOPE PHARMACEUTICAL CO LTD1 active DMF
• Zhejiang Huayi Pharmaceutical Co., Ltd.China1 active DMF
• SYNTHIMED LABS PRIVATE LIMITEDIndia1 active DMF GMP on record
• Sichuan Kelun Pharmaceutical Co., Ltd.China1 active DMF
• FRESENIUS KABI ONCOLOGY LTDIndia GMP on record
• Cipla USA, Inc.USA

Patent & exclusivity (US)

Per the FDA Orange Book (6 approved US products), the latest listed US patent on Ibrutinib expires 14 Jun 2039 and exclusivity 24 Feb 2030. Generic API sourcing typically opens up once these lapse.

Therapeutic areas