Generic drug maker Mylan has announced that the US Patent and Trademark Appeal Board (PTAB) invalidated Sanofi’s patent infringement claims over insulin drug Lantus.
Lantus is a long-acting insulin indicated for the treatment of adults with type 2 diabetes, as well as adults and paediatric patients with type 1 diabetes to control high blood sugar.
Sanofi markets the product in vials (Lantus) and as a disposable injection pen (Lantus SoloSTAR).
Mylan is developing generic versions of the medication, and its new drug application (NDA) for a generic Lantus and Lantus SoloSTAR is under review by the US Food and Drug Administration (FDA).
Sanofi filed a patent infringement lawsuit against Mylan’s NDA in October last year, including patents covering both Lantus formulations.
Mylan CEO Heather Bresch said: “For years, Mylan has been investing in the development of a more affordable generic to insulin glargine for diabetes patients.
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“The PTAB’s favorable ruling that invalidates two Sanofi Lantus formulation patents is an important step forward in our journey to help address the needs of nearly 30 million Americans living with diabetes.”
Following Mylan’s announcement, Sanofi shares dropped by 1%, as reported by Reuters.
However, Sanofi said that Mylan will not be able to launch generic Lantus.
Sanofi was quoted by the news agency as saying: “We believe that it is unlikely that the Patent Trial and Appeal Board (PTAB) ruling on the formulation patents will have an impact on Mylan’s timing for a launch of its glargine products.
“The PTAB decision alone does not affect the existing 30-month stay and Mylan does not have tentative FDA approval for its products at this time.”
For the 12 months ending on 31 October 2018, the Sanofi recorded approximately $2.14bn and $4.39bn in total IQVIA sales for Lantus 100 Units/mL and Lantus SoloSTAR, respectively.