Mylan N.V. announced that the US Patent and Trademark Appeal Board (PTAB) has instituted inter partes review (IPR) proceedings on all claims against two Orange Book-listed patents owned by Sanofi for Lantus (insulin glargine injection) 100 Units/mL.
“Mylan’s 505(b)(2) New Drug Application (NDA) for Insulin Glargine in vial and pen dosage forms is under active review with the U.S. Food and Drug Administration,” said Mylan.
“Lantus and Lantus Solostar are prescription medicines indicated for improving glycemic control in adult patients with diabetes mellitus.”
Mylan CEO Heather Bresch said: “The PTAB’s decision to institute IPR proceedings against the two Orange Book-listed patents for Lantus is another step forward in our ongoing efforts to bring an interchangeable insulin glargine to diabetes patients as soon as possible.
“There are more than 29 million people in the U.S. living with diabetes who deserve access to more affordable treatment options.
“As a leading producer of oral diabetes medicines, we are deeply committed to this patient community and believe bringing lower-cost alternatives to Lantus and Lantus SoloSTAR will fulfill a critical medical need.”
Mylan said that in October, Sanofi initiated patent infringement litigation against Mylan’s NDA in the US District Court for the District of New Jersey that includes the two Lantus patents.
“Total IQVIA sales for the 12 months ending Oct. 31, 2017, were approximately $2.74 billion for Lantus 100 Units/mL and about $4.98 billion for Lantus SoloSTAR,” added Mylan.