Namenda XR Generics Coming Soon? US Court Rulings Clear Path For Multiple Launches
Seven companies hold final ANDA approval for Alzheimer's drug, but Allergan still has chance to block them as it seeks rehearing of appeals court's patent decision. Meanwhile, Amneal might block other generics if it can get an appeals court to grant it the 180-day marketing exclusivity for memantine extended-release it says that FDA unfairly denied it.
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Hemophilia and immuno-oncology will be in the spotlight as earnings season continues into February. Will Bristol be a buyer or an acquisition target? How will Sanofi fare with its new acquisitions? And how will Teva and GSK fare as they face generics for top brands?
Allergan will spend 2018 trying to shift investor focus from the loss of Restasis patent exclusivity in the second half of the year to the company's R&D pipeline, including the late-stage "six stars" highlighted in 2017 and mid-stage programs that are moving into the spotlight.
Now approved as an interchangeable biosimilar, US labeling for Viatris’ insulin aspart mirrors that of Sanofi’s Lantus and has shed data from two studies in type 1 and 2 diabetics that showed noninferiority to Sanofi’s Lantus; Viatris appears in line for one year of exclusivity.