Top US Generics Players Thwarted On August At-Risk Launch Of Fingolimod
Difficulties around damages, fears over first-dose observations and criticism of invalidity challenges all contributed to a US district court judge issuing a preliminary injunction to stop leading generics players launching rivals to Novartis’ Gilenya fingolimod multiple sclerosis brand after the molecule patent expires in August this year.
You may also be interested in...
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.
Imminent generic competition to Novartis’ Gilenya blockbuster in the US now seems impossible after a US district court held that the company’s dosage-regimen patent was both valid and infringed by HEC’s ANDA product. The Chinese firm may yet appeal the decision.
Zeposia, one of three Celgene candidates central to last year’s merger with BMS, obtains US FDA approval in relapsing MS. BMS, however, will delay the launch due to the COVID-19 pandemic.