You kind of have to ask that question as the lawsuit gives 30 months to keep a new generic product off the market, which occurs by just filing the lawsuit. So Is Sanofi buying time here with preventing Lilly from producing a generic version of the drug Lantus?
Sanofi also has another insulin drug in the works called U300, which needs approval but depending when it may or may not get approval, this buys more time to switch patients to their new potential insulin drug. Lilly of course is challenging the lawsuit. One Lilly filed with the FDA looking for permission to sell generic version, the lawsuit appeared. BD
Jan 30 (Reuters) - French drugmaker Sanofi sued Eli Lilly and Co on Thursday, alleging that the U.S. pharmaceutical company infringed patents on its top-selling diabetes treatment, the insulin product Lantus.
The lawsuit, filed in United States District Court for the District of Delaware, was triggered by notification from Lilly last month that it applied with the U.S. Food and Drug Administration (FDA) seeking permission to sell a generic version of Lantus, known chemically as insulin glargine.
Lilly, in its submission, challenged the validity of several patents on Lantus held by Sanofi.
Lantus is the world's most prescribed insulin product, with annual worldwide sales of about $7 billion.
But the patent infringement lawsuit triggers an automatic 30-month stay of a generic approval by the FDA, which would keep Lilly's generic off the market until mid-2016.