Sanofi takes on Mylan over diabetes injection
Sanofi has taken on Mylan in its latest lawsuit over Lantus (insulin glargine injection), which is used to help control the blood sugar level of those with diabetes.
Yesterday, October 24, Sanofi announced it had sued Mylan in the US District Court for the District of New Jersey, alleging infringement of 18 patents.
The dispute was triggered by Mylan’s notification that it had filed a New Drug Application (NDA) with the US Food and Drug Administration (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,” said Sanofi in a press release.
According to Sanofi’s suit, there are no unlicensed generic or follow-on versions of Lantus or Lantus SoloStar on the US market.
Sanofi sued Merck in September last year, accusing the company of infringing ten of its patents for Lantus.
Two years before, Eli Lilly was hit with a lawsuit which claimed that the company had infringed seven Lantus patents.
“Mylan’s actions, including but not limited to the filing of Mylan’s NDA, and Mylan’s systematic attempt to meet the applicable regulatory requirements for approval of that NDA, indicate a refusal to change its course of action,” argued Sanofi.
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