New patents
Crucially, these newly granted manufacturing patents, which expire in 2036, provide an additional layer of protection by covering the process by which paxalisib is manufactured.
According to Kazia, any generic competitor would now need to develop an alternative method of chemical synthesis, which is technically challenging and hence a costly exercise.
Interestingly, existing ‘composition of matter’ patents for the chemical structure of paxalisib generally expire in 2031 but are likely to be eligible for a five-year patent term extension in key territories.