GENERIC PHARMA companies frequently start formulation studies on a brand product as soon as it is launched, in order to prepare for the filing of the generic a decade later. Being first to file gains the 180 day exclusivity that makes the effort worthwhile. Along the way are a complex series of hurdles, including patent challenge litigation, deals with the innovator to become an Authorized Generic, and fierce competition to be first to file. The landscape of generic companies continues to shrink due to M&A activities, and the strategies available to remain competitive get narrower every year.
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linkedin post 2022-06-29 05:12:48
Nigel Fleming
September 21, 2022