Sotorasib is an oral Kirsten Rat Sarcoma Virus (KRAS inhibitor designed to potently and selectively target the KRAS G12C mutation. It received accelerated approval from the US FDA in 2021 for the treatment of NSCLC. Notably, in January 2025, the FDA granted accelerated approval for sotorasib in combination with immunotherapy for adults with KRAS G12C-mutated colorectal cancer, further reinforcing its potential across multiple tumour types. The primary patent on sotorasib has been granted in many LMICs and is expected to expire in 2038. Several secondary patents on crystalline forms and processes are expected to expire between 2039 and 2040.