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.

Related news:

Sanofi sues Eli Lilly over challenge to top diabetes drug Lantus (Reuters).

Reference links:

Sanofi files suit in the US to defend its patent rights (Sanofi press release, PDF).