BioCryst files patent infringement lawsuit against Annora Pharma over generic ORLADEYO

BIOCRYST PHARMACEUTICALS INC

Annora Pharma sought FDA approval for generic ORLADEYO, challenging three patents expiring in 2039.
BioCryst filed suit March 10, 2025, in Delaware District Court against Annora, Hetero Labs, Hetero USA, and Camber.
Lawsuit seeks to enjoin generic launch and order FDA approval only after 2039 patent expiry (including extensions).
Six other ORLADEYO Orange Book patents expiring in 2035 were not challenged by Annora.
Company intends to vigorously enforce intellectual property rights protecting ORLADEYO.

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