Sanofi accuses Lilly of Lantus patent infringements
Blockbuster diabetes drug insulin glargine injection (Lantus) is the subject of a lawsuit by its maker Sanofi, which alleges that Eli Lilly has infringed patents, a move that will keep the competitor’s biosimilar off the market for longer, until at least mid-2016.
“The suit was triggered by notifications received from Lilly beginning in mid-December, in which Lilly stated that it had filed a new drug application with FDA for an insulin glargine drug product.
“Lilly also stated that its NDA included a paragraph IV certification challenging six of the seven Sanofi patents listed in the FDA orange book for Sanofi’s Lantus and Lantus SoloStar products.”
Statement to the media, Sanofi.
Sanofi files suit in the US to defend its patent rights (Sanofi press release, PDF).
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