Indivior's New Suboxone Patent Cannot Keep Dr. Reddy's Generic Off Market
Executive SummaryUS Federal Circuit applies new standard in finding continuation patent claims are indistinct from those in parent patent, vacates preliminary injunction.
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Dr Reddy’s can re-launch its generic version of Indivior’s Suboxone (buprenorphine/naloxone) sublingual film in the US following a crucial court ruling that has gone its way. Indivior faces significant turbulence ahead if a generic entry materializes soon.
Complaint challenges agency's revised definition of "first applicant," which does not require notice of Paragraph IV certification to obtain exclusivity.
Launch comes immediately after FDA approval of Dr. Reddy's and Mylan ANDAs while Indivior appeals district court ruling of non-infringement; Mylan settlement may delay its entry.