Needham & Company Maintains a 'Strong Buy' on Mylan (MYL)l Mid-May Is D-Day for Generic Lidoderm, Not July
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Price: $15.86 --0%
Rating Summary:
17 Buy, 13 Hold, 0 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 9 | Down: 8 | New: 13
Rating Summary:
17 Buy, 13 Hold, 0 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 9 | Down: 8 | New: 13
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Needham & Company maintains a 'Strong Buy' on Mylan (NASDAQ: MYL) price target of $29.00.
Analyst, Elliot Wilbur, says, "In the fast and furious world of paragraph IV patent challenges, he who files first usually steals the show. However, given the unprecedented backlog of generic applications sitting at FDA and the dramatic deceleration in approval times, we are encountering more situations in which generic first filers, through no fault of their own, are increasingly at risk of losing 180-day exclusivity because they are unable to secure tentative approval within the 30 months of filing. This possibility is certainly worth pointing out with respect to generic Lidoderm, a product in which only two generic filers have emerged to date−Watson (N&YSE: WPI)(Hold) and Mylan. Watson has received all the attention of course because of its first-to-file status, a favorable outcome in early litigation proceedings, and the approaching 30-month window expiry. Watson management, in response to commentary from Endo (Nasdaq: ENDP)(Hold) counsel in a court document suggesting that a bioequivalence study issue could delay Watson’s approval, reaffirmed prior commentary that it fully expects to receive tentative approval by July 15, the 30-month stay expiry."
For an analyst ratings summary and ratings history on Mylan click here. For more ratings news on Mylan click here.
Shares of Mylan closed at $22.44 yesterday.
Analyst, Elliot Wilbur, says, "In the fast and furious world of paragraph IV patent challenges, he who files first usually steals the show. However, given the unprecedented backlog of generic applications sitting at FDA and the dramatic deceleration in approval times, we are encountering more situations in which generic first filers, through no fault of their own, are increasingly at risk of losing 180-day exclusivity because they are unable to secure tentative approval within the 30 months of filing. This possibility is certainly worth pointing out with respect to generic Lidoderm, a product in which only two generic filers have emerged to date−Watson (N&YSE: WPI)(Hold) and Mylan. Watson has received all the attention of course because of its first-to-file status, a favorable outcome in early litigation proceedings, and the approaching 30-month window expiry. Watson management, in response to commentary from Endo (Nasdaq: ENDP)(Hold) counsel in a court document suggesting that a bioequivalence study issue could delay Watson’s approval, reaffirmed prior commentary that it fully expects to receive tentative approval by July 15, the 30-month stay expiry."
For an analyst ratings summary and ratings history on Mylan click here. For more ratings news on Mylan click here.
Shares of Mylan closed at $22.44 yesterday.
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