Ranbaxy, the Indian subsidiary of Daiichi Sankyo, has 180-day first-filer exclusivity for generic Lipitor but it does not have FDA approval to launch due to manufacturing problems. Should this hold up the launch of other Lipitor generics that do have FDA approval? Ranbaxy says yes, and MYL (which settled with PFE—#msg-59174853) says no. Not surprisingly, the FDA is siding with Ranbaxy.
Meanwhile, WPI has approval to sell PFE’s authorized generic (#msg-58721867) and hence is indirectly affected by the outcome of the Ranbaxy-MYL case.
Does anyone need a scorecard? :- )
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