Ribociclib
Overview
Ribociclib is a selective cyclin-dependent kinase inhibitor used in the treatment of breast cancer. It works by inhibiting cyclin D1/CDK4 and CDK6, blocking retinoblastoma protein phosphorylation and cell cycle progression.
API suppliers (1)
Suppliers of Ribociclib evidenced by a US FDA Type II Drug Master File or an EU Certificate of Suitability (CEP). Sources: FDA DMF list, EDQM certification database.
1 of 1 holds a GMP certificate on record in the EU or UK registers
- MSN Laboratories Private LimitedIndia1 active DMF GMP on record
Patent & exclusivity (US)
Per the FDA Orange Book (1 approved US product), the latest listed US patent on Ribociclib expires 14 Oct 2036 and exclusivity 17 Mar 2028. Generic API sourcing typically opens up once these lapse.
Therapeutic areas
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