Medical Marketing and Media - Rulings may clear pathway for generic Neurontin, Paxil
In mid-January, the FDA was close to a decision on pending applications for a generic form of Neurontin (gabapentin), based on a federal court’s complicated patent decision.The Washington, D.C., federal court directed the FDA to accept the ANDA submitted by Purepac, which is eligible for 180 days of exclusivity as the first sponsor. TorPharm was first to file on a different section of the patent, and is seeking shared exclusivity, according to a report.
Alpharma announced a favorable court ruling indicating that the company followed proper procedure in seeking approval for generic gabapentin, contrary to an FDA ruling that it had improperly filed its application. Teva and Eon also have pending “approvable” ANDAs and all are on hold awaiting results of ongoing litigation with Pfizer.
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Separately, a Philadelphia court issued a split ruling on a motion for summary judgment of non-infringement by Apotex on four “product-by-process” claims for GlaxoSmithKline’s Paxil (paroxetine.) The court granted the Apotex motion on most claims, but denied the others. GlaxoSmithKline reportedly has received five 30-month stays on Paxil patents since mid-1998.
Apotex said it views the decision as a victory since only one Paxil product claim remains, which is being reviewed; GSK said the judgment is a split decision and plans to appeal. Paxil, which had worldwide sales of close to $3 billion last year, has patent protection until 2006, according to GSK.
Copyright CPS Communications Feb 2003
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