regulatory
confidence high
sentiment negative
materiality 0.70
Mylan files ANDA for generic APONVIE; Heron to defend 10 patents
HERON THERAPEUTICS, INC. /DE/
- Mylan filed paragraph IV certification notice for generic version of APONVIE (aprepitant).
- Heron will file patent infringement lawsuit within 45 days of December 18, 2023 notice.
- 10 Orange Book-listed patents expiring September 18, 2035 are challenged as invalid or not infringed.
- FDA approval of Mylan's ANDA stayed for 7.5 years if suit is timely filed, absent court ruling.