In broad terms, my understanding is that generic manufacturers...

In broad terms, my understanding is that generic manufacturers only need to demonstrate their drug is bioequivalent to the originator product. They do not need to run the same trials or show any patient outcome data. Hence they are able to market them so cheaply - but only after the patent period for the originator brand has ended.

The patent period for PPS ended in 2012. So if another company was able to manufacture PPS to standards approved by the likes of the FDA in the US and TGA in Australia - they would go straight to registering it for use. PAR clearly is confident this does not present an immediate threat in the short to medium term.