Sanofi Defends US Patent for Top-Selling Product LantusBy
Sanofi has filed a patent-infringement suit against Merck Sharp & Dohme Corp. in the US District Court for the District of Delaware alleging the infringement of 10 patents related to its insulin products, Lantus (insulin glargine) and Lantus Solostar. The suit was triggered by a notification received from Merck in early August 2016, in which Merck stated it had filed a new drug application (NDA) 505(b)2 with the US Food and Drug Administration for an insulin glargine drug product. Merck also stated that its NDA included a Paragraph IV certification challenging all of the 10 Sanofi patents listed in the FDA Orange Book for Sanofi’s Lantus and Lantus SoloStar products.
Lantus is Sanofi’s top-selling product, with 2015 sales of EUR 6.4 billion ($7.1 billion). Lantus is facing generic competition. In 2015, the FDA approved Eli Lilly and Company’s Basaglar (insulin glargine injection) 100 units/mL, a long-acting insulin with an identical amino acid sequence to Lantus. Per Lilly’s settlement agreement with Sanofi, Basaglar became e available in the US starting on December 15, 2016.
Sanofi is repositioning itself with its next-generation insulin glargine, Toujeo, which gained marketing authorization in the three major markets (US, European Union, and Japan) in 2015 and is now approved in 20 countries overall. Some analysts peg Toujeo as a potential blockbuster drug. A Thomson Reuters analysis projects Toujeo sales to reach $1.299 billion in 2019.