Sunday, March 03, 2024 8:11:39 AM
As I said before, okay, Elite filed the Paragraph IV certificate with the -- with its ANDA generic OxyContin and as that Elite got accepted by the FDA, after the ANDA, got accepted by the FDA, Elite sent the patentee, as we're required by law, and the NDA holder, a notice letter. And that's required by Hatch Waxman, okay. This was followed by a Patent Infringement Lawsuit, filed in the District Court of New Jersey by Purdue Pharma, standard procedure.
Elite obtained an agreement with Purdue, to stay the litigation for six months. Elite's launch of the generic Oxycontin will depend on the approval by the FDA and the outcome of the various litigations involved with Purdue, okay? Or if the patent expired and especially those that are listed in the orange book, okay?
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