Mylan filed an ANDA [79-051] for Nisoldipine ER and in September 2007 sent a letter to Sciele [NDA holder] informing its action of seeking approval to market the 40mg strength. Sciele had then filed a complaint for patent infringement against Mylan for Nisoldipine ER tablet [Sular ®] in October 2007 at the Delaware District Court.
The patent in question was Orange Book listed US4892741.
In November 2007, Mylan sent another letter to Sciele, informing its action of seeking approval to market the 20mg and 30mg strengths as well. Sciele then filed the present patent infringement [for the same '741 patent] to cover the 20mg and 30mg strengths of Nisoldipine ER.
Tuesday, December 18, 2007
Sciele v/s Mylan .. another lawsuit
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