Key Takeaway
The more generic options available following orphan medicine loss of exclusivity, the greater the cost savings.
When orphan medicines lose exclusivity, we often assume generic competition will improve affordability and patient access. But does that happen in practice?
Our team conducted an analysis of 31 orphan medicines withdrawn from the European Community Register on expiration of orphan exclusivity between 2008 and 2020.
What did we find?
- Despite loss of exclusivity and patent expiration, only a minority of expired orphan medicines included in our analysis (9/31) had undergone genericisation.
- Generic entrants led to substantial price reductions.
- There was a clear correlation between the number of generic competitors and price decline, underscoring the potential for increased competition to drive further cost savings.
We believe that increased competition post patent expiration could play an important role in addressing the ongoing challenge of access of high-cost orphan medicines across Europe.