J&J Dismisses Concerta Patent Suit Against Impax
This article was originally published in The Pink Sheet Daily
"Odd" case against the first-filer ends, but litigation with Andrx continues.
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J&J recently listed a new patent for Concerta, and another generic company appears to hold 180-day exclusivity based on that patent, Andrx says.
McNeil’s citizen petition requests FDA apply additional bioequivalence requirements for Concerta ANDAs. With no patent exclusivity remaining on the innovator product, multiple generics could be approved if FDA rejects McNeil’s arguments.
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.