Eli Lilly has entered into a settlement agreement to resolve patent litigation with Sanofi regarding its insulin glargine product, Basaglar.
Lilly said this in a press release issued on Monday, where it is stated that 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.
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.
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 company said that further details regarding the settlement were confidential.
The U.S. Food and Drug Administration tentatively approved Basaglar in August 2014. With this resolution, Lilly says that it 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 U.S. 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 U.S. in December of 2016.”