Nuvo Research Inc.announced today that it has entered into a settlement agreement with Apotex Inc. and Apotex Corp. (together Apotex) respecting patent infringement litigation brought by Nuvo and Nuvo’s U.S. licensing partner, Mallinckrodt Inc. (Mallinckrodt), in response to Apotex’s filing of an abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of PENNSAID (diclofenac sodium topical solution) 1.5% w/w (PENNSAID).
Under the terms of the settlement agreement, Nuvo and Mallinckrodt granted a license to Apotex that permits Apotex, upon approval of its ANDA by the FDA, to launch its generic version of PENNSAID on a date that is the earlier of 45 days after Mallinckrodt or Nuvo makes a first commercial shipment of PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2 in the United States and April 1, 2014, or earlier under certain circumstances.
PENNSAID 2% is pending approval by the FDA and is expected to be the follow-on product to original PENNSAID. PENNSAID 2% is designed to be dosed twice per day with a metered dose pump bottle. In 2012, Mallinckrodt submitted a New Drug Application (NDA) for PENNSAID 2% with the FDA. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of March 4, 2013 for action on the submission.