Novartis Fends Off US Fingolimod Competition – For Now
No Gilenya Generics Expected ‘For At Least The Next Two Years’ In US, Originator Says
The latest decision in US litigation with HEC Pharma over multiple sclerosis treatment Gilenya means that generics will be kept off the market for at least two years, according to originator Novartis.
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Novartis is sticking to its plan to continue fighting HEC Pharm in court, after it recently lost a key decision for its Gilenya (fingolimod) blockbuster treatment for multiple sclerosis.
China’s HEC Pharm, the last ANDA filer for fingolimod standing in patent litigation, has won a key invalidity challenge against a dosing-regimen patent shielding the multiple sclerosis treatment. However, the Federal Circuit was split on whether it had applied a heightened standard for negative claim limitations.
In 2021, courts across the US and beyond continued to weigh key patent litigation fights, alongside the thorny issue of induced infringement via label carve outs and controversial charges for generic price fixing.