Nuvo, Mallinckrodt settle litigation with Apotex surrounding generic Pennsaid

Nuvo Research Inc. and its US marketing partner Mallinckrodt PLC (a division of Covidien PLC) have settled patent litigation with Apotex Inc., which had filed an ANDA to market a generic version of the topical knee osteoarthritis treatment Pennsaid (diclofenac 1.5%). Nuvo granted Mallinckrodt exclusive rights to market Pennsaid in the US in mid-2006. Under terms of the settlement, Nuvo and Mallinckrodt have granted Apotex a license to launch the generic 1.5% version, once approved, starting either April 1, 2014, or 45 days after Nuvo or Mallinckrodt make a first commercial shipment of Pennsaid 2% in the US, whichever is earlier. Pennsaid 2% is currently awaiting FDA approval. (Mallinckrodt submitted the NDA in 2012.)