Wednesday, August 15, 2012

Para-IV filed on Janumet XR

This is the first  Para-IV filing on Janumet XR (Januvia +metformin XR, Type 2 diabetes). The drug is expected to reach peak sales of $4billion and represents a major opportunity for generic companies.  Mylan, Teva, Dr. Reddy, Sun, Sandoz could be the probable filer.
 The next target for generic companies could be a Para-IV on Juivsync (Januvia + Simvastatin). Currently Juvisync sales are miniscule, but should gradually build up over time. Majority of Diabetes patients are on concomitant statins and Januvia being the preferred DPP-IV, Juvisync sales should also pick up over time. Merck is also developing a fixed dose combination of Januiva and Lipitor and should reach market by 2014. The launch and  penetration of of these FDC's would help Januvia franchise sustain and grow its leadership position in the DPP-IV space.
 The future sales of Januvia monotherapy could also be impacted by the entry of these FDC's and once weekly DPP-IV inhibitors. Januvia monotherapy currently sells about $3.5b annually, but the sales will decline over time. A Para-IV has already been filed on Januvia.