Lilly and Sanofi reach settlement agreement in US insulin glargine litigation
Pending final FDA approval, Basaglar can be launched in the US beginning on 15 December 2016.
Eli Lilly and Company has entered into a settlement agreement to resolve patent litigation with Sanofi regarding its insulin glargine product, Basaglar. As a part of the agreement, Lilly and its alliance partner, Boehringer Ingelheim, will have the ability to launch Basaglar in the US on 15 December 2016. Under the terms of the agreement, Sanofi has granted Lilly a royalty-bearing license so Lilly can manufacture and sell Basaglar in the Kwikpen device globally.
The FDA tentatively approved Basaglar in August 2014. With this resolution, Lilly plans to request final approval of Basaglar from the FDA.
"The settlement agreement ends the legal dispute between Lilly and Sanofi and provides us with certainty as it relates to our US launch timing," said Michael J. Harrington, senior vice president and general counsel for Lilly. "This enables us to focus our efforts on preparing to successfully market and launch Basaglar in the US in December of 2016."
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