Sanofi announced that it filed a patent infringement suit against Merck Sharp & Dohme Corp. in the United States District Court for the District of New Jersey. In its suit Sanofi alleges infringement of two patents.
Lantus® (insulin glargine injection) is basal insulin approved for use once-a-day. It should be administered at the same time each day to keep insulin level steady. It is a long-acting insulin used to treat adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar.
The suit was triggered by a notification received from Merck in late June, in which Merck stated that it had filed an NDA (505(b)(2) New Drug Application) with FDA for an insulin glargine vial drug product. Merck also stated that its NDA included a paragraph IV certification challenging all of the Sanofi patents then listed in the FDA Orange Book for Sanofi’s Lantus® and Lantus® SoloStar® products.
