Sanofi has reached a settlement agreement with Eli Lilly and Company, which addresses patents on Sanofi’s Lantus SoloSTAR (insulin glargine). The agreement resolves a US 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 US, Lilly will not sell its insulin glargine product before December 15, 2016. The agreement does not include Sanofi’s Lantus (vial), Toujeo, or combination products. The remaining settlement terms are confidential.

The disputed product related to Eli Lilly’s 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 December 15, 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 US Food and Drug Administration (FDA) tentatively approved Basaglar in August 2014. With this resolution, Lilly plans to request final approval of Basaglar from the FDA.

Source: Sanofi and Eli Lilly and Company