Morgan Stanley Reports Mylan Seeking FDA Approval Of Generic Lipitor In June 2011 For Watson Pharmaceuticals

In a report published by Morgan Stanley, Mylan is seeking FDA approval of generic Lipitor in June 2011 for Watson Pharmaceuticals WPI. Morgan Stanley said that Mylan is suing FDA to deny Ranbaxy's 180 days of marketing exclusivity on generic Lipitor. “If FDA denies Ranbaxy's exclusivity, MYL says that FDA could grant final approval of Lipitor generics as early as Jun. 28, 2011 when Pfizer's ‘995 patent expires. This could theoretically result in Teva and MYL launching generic Lipitor about 11 months early (investors currently expect launch in May ‘12 after Ranbaxy's exclusivity ends). While we assume TEVA and MYL's entry would trigger WPI's launch of the Authorized Generic, this would result in WPI competing against two generics at launch vs. just Ranbaxy.” Watson Pharmaceuticals closed yesterday at $54.30.
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