Sanofi has filed a patent infringement suit against Mylan N.V., Mylan GmbH, Mylan and Mylan Pharmaceuticals (collectively, Mylan) in the United States District Court for the District of New Jersey. Sanofi alleges infringement of 18 patents in its suit
The suit was triggered by notifications received from Mylan beginning in mid-September, in which Mylan stated that it had filed a NDA (505(b)(2) New Drug Application) with the FDA for insulin glargine pre-filled pen and vial drug products. Mylan 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 (insulin glargine injection, 100 Units/mL) and Lantus SoloStar products.
Sanofi files patent, infringement suit against mylan, lantus & lantus solostar products
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