- Basaglar, which is co-marketed by Eli Lilly and Boehringer Ingelheim (BI), is a biosimilar version of Sanofi's Lantus SoloSTAR (insulin glargine) that was tentatively approved by the FDA in August 2014. The companies have been embroiled in a contentious patent infringement lawsuit in which Sanofi alleged that Lilly infringed its patents.
- Lilly and Sanofi have now settled their legal dispute, and Eli Lilly will launch Basaglar in December 2016, based on the terms of the settlement.
- In addition, as part of the settlement, Lilly will pay Sanofi royalties in exchange for a license for certain patents.
After 15 years as one of the most popular basal insulins, the pediatric exclusivity patent on Sanofi's Lantus, which had a little more than $7 billion in sales last year, expired in May—though there are several other active patents for the product.
When Basaglar was approved by the FDA last year, a 30-month stay was implemented. But there have been ongoing negotiations resulting in six more months of Lantus revenues for Sanofi, and the opportunity for Lilly and BI to launch Basaglar in the U.S.
Basaglar, which is marketed as Abrasia in the E.U., was approved last year by E.U. regulators and will launch in that market during the third quarter of this year.