Eli Lilly and Co. has negotiated the right to market a knockoff version of the world’s top-selling insulin, Lantus. ( LLY ) said that it has entered into a settlement agreement to resolve patent litigation with Sanofi regarding its insulin glargine product, Basaglar.
Lilly and Boehringer received tentative US approval in 2014 to sell Basaglar, but the launch has been delayed by the lawsuit filed by Sanofi in early 2014.
Lilly said that Sanofi has granted the company a royalty-bearing license to make the drug and sell it globally in Kwikpens, prefilled insulin dosing devices.
With the latest resolution, Lilly plans to request final approval from the FDA.
The settlement relates to patents covering Sanofi’s Lantus SoloSTAR formulation of the basal insulin, a pen injector version which accounts for nearly two-thirds of Lantus $7bn total sales. The agreement does not include Lantus (vial), Toujeo or combination products. Sanofi and Lilly agreed to end that lawsuit and to discontinue similar disputes worldwide, according to Sanofi. “This enables us to focus our efforts on preparing to successfully market and launch Basaglar in the U.S.in December of 2016”.
The settlement provides Sanofi a short term relief due to the extra six months of patent protection and will add to the company’s profit in the near term, analysts at Morgan Stanley and Deutsche Bank said.