The ‘loss of exclusivity date’ (LoE) is the date that generic or biosimilar manufacturers can launch their own versions of a product onto the market. This does not mean that generic and biosimilar products will become available on that date, only that they could.
The LoE date is the latest of:
- the date of loss of relevant patent protection
- the date of loss of data exclusivity and market protection
Once exclusivity has been lost, other factors such as commercial viability will influence whether and when a generic or biosimilar becomes available.