Sanofi files suit in U.S.
Defending patent rights on Lantus® and Lantus® Solostar®
The suit was triggered by a notification received from Merck in early August, in which Merck stated that it had filed an NDA (505(b)(2) New Drug Application) with FDA for an insulin glargine drug product. Merck also stated that its NDA included a paragraph IV certification challenging all of the ten Sanofi patents listed in the FDA Orange Book for Sanofi's Lantus® and Lantus® SoloStar® products.
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