Generics Eye Gemzar

Sicor Pharmaceuticals Inc., Mayne Pharma Inc. and Sun Pharmaceutical Industries Inc. had separately filed Para IV challenges against Eli Lilly’s blockbuster anticancer Gemzar eyeing US $ 1.4 billion market. In response, Lilly has filed three separate patent infringement lawsuits against the generic challengers, which subsequently triggered 30-months stay of final generic approval against the ANDAs. Gemcitabine hydrochloride, the active ingredient of Gemzar is protected by the US 4,808,614 (the 614 patent) which is valid till November 15, 2010 including pediatric exclusivity whereas it’s FDA approved indication is covered by the US 5,464,826 (the ‘826 patent) including pediatric exclusivity. Gemcitabine hydrochloride is analog of pyrimidine nucleosides exemplified in the US 4,211,773 (the ‘773 patent).