Sanofi sues US generic drugmaker over Lantus patent rights
Amid falling sales of its leading diabetes product Lantus (insulin glargine) due to generic competition, French pharma major Sanofi (Euronext: SAN) is taking further legal action in the USA.
This time it has filed a patent infringement suit against Netherlands-headquartered drugmaker Mylan (Nasdaq: MYL) and certain subsidiaries in the US 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 an NDA (505(b)(2) New Drug Application) with the Food and Drug Administration 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 LantusSoloStar products.
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