The current approach to manufacturing compounded medications is outdated and poorly optimised - failing both pharmacies and the patients they serve. Even with highly trained pharmacists and modern equipment, the process remains unnecessarily labour-intensive, prone to human error, and inconsistent in quality.
The FTC's recent letter campaign could result in prolonged litigation beyond Hatch-Waxman timelines, impacting patent validity and consumer access to generics.
The Federal Circuit confirmed that Mylan's generic label in its ANDA could lead to induced infringement of Janssen's antipsychotic patents, emphasizing label intent.