Abemaciclib

Overview

Abemaciclib is an orally administered selective inhibitor of cyclin-dependent kinases 4 and 6, which are key regulators of the cell cycle. It is primarily used in the treatment of hormone receptor-positive, HER2-negative breast cancer.

API suppliers (15)

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

• MSN Laboratories Private LimitedIndia2 active DMF GMP on record
• Shandong Anhong Pharmaceutical Co., Ltd.China1 active DMF GMP on record
• Formosa Laboratories, Inc.Taiwan1 active DMF GMP on record
• Hetero Labs LimitedIndia1 active DMF GMP on record
• CHANGZHOU PHARMACEUTICAL FACTORYChina1 active DMF GMP on record
• SCINOPHARM TAIWAN LTDTaiwan1 active DMF
• ZAKLADY FARMACEUTYCZNE POLPHARMA SA1 active DMF
• BEIJING HOPE PHARMACEUTICAL CO LTD1 active DMF
• Granules India LimitedIndia1 active DMF GMP on record
• Egis Pharmaceuticals PLCHungary1 active DMF GMP on record
• SICHUAN ELIXIR PHARMACEUTICAL CO LTD1 active DMF
• Alembic Pharmaceuticals LimitedIndia1 active DMF GMP on record
• BIOPHORE INDIA PHARMACEUTICALS PVT LTD1 active DMF
• Cipla USA, Inc.USA1 active DMF
• DR REDDYS LABORATORIES LTD1 active DMF GMP on record

Patent & exclusivity (US)

Per the FDA Orange Book (4 approved US products), the latest listed US patent on Abemaciclib expires 28 Sept 2031. Generic API sourcing typically opens up once these lapse.

Therapeutic areas