NorthWest Biotherapeutics Inc (NWBO)

[eagle8]

Of course, the orphan drug status that was granted to NWBO is now 11 years ago.

Market exclusivity is available to developers of orphan-designated drugs to provide protection from competition after approval as a way of incentivizing development of drugs for rare diseases. In the US, developers get seven years exclusivity from the same drug being approved for the same indication. Although this was recently challenged, the US Food and Drug Administration (FDA) intends to continue restricting the scope of exclusivity to the same indication. In the EU, 10 years’ protection from similar drugs being approved is available.

Keywords – market exclusivity, orphan designation, rare diseases

https://www.raps.org/News-and-Articles/News-Articles/2023/6/Market-exclusivity-for-orphan-drugs-in-the-US-and