Sanofi Files Patent Infringement Suit Against Mylan Over Lantus Generic

Sanofi sued Mylan this week in the U.S. District Court for the District of New Jersey alleging the generic drugmaker infringed on 18 of its patents.

According to the complaint, Mylan notified the company last month of its NDA for an insulin glargine pre-filled pen and vial-drug that runs afoul of Sanofi’s patents covering the branded insulin glargine products Lantus and Lantus SoloSTAR.

Sanofi said it received an offer of confidential access (OCA) from Mylan for the NDA, but its efforts since then to obtain a copy of the NDA were fruitless, because of “onerous and unreasonable restrictions on production, disclosure, and use of the information under the OCA insisted upon by Mylan.”