Lilly,Sanofi Enter Into Settlement Agreement In U.S. Insulin Glargine Litigation

(RTTNews) - Eli Lilly and Co. (LLY) said that it 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 U.S. on December 15, 2016.

As per 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. Further details regarding the settlement are confidential.

The U.S. Food and Drug Administration tentatively approved Basaglar in August 2014. With this resolution, Lilly plans to request final approval of Basaglar from the FDA.

Separately, Sanofi confirmed that it has reached a settlement agreement with Eli Lilly and Company, which addresses patents on Sanofi's Lantus SoloSTAR (insulin glargine). The agreement resolves a U.S. patent infringement lawsuit regarding Lilly's pursuit of regulatory approval for a product that would compete with Lantus SoloSTAR. Sanofi and Lilly agreed to end that lawsuit and to discontinue similar disputes worldwide.

Under the agreement, Lilly will pay royalties to Sanofi in exchange for a license to certain Sanofi patents. In the U.S., Lilly will not sell its insulin glargine product before December 15, 2016. The agreement does not include Lantus (vial), Toujeo or combination products. The remaining settlement terms are confidential.