PALATINE, IL - Acura Pharmaceuticals Inc., a specialty pharmaceutical company developing products intended to address medication abuse and misuse, announced in a press release that it has entered into a Settlement Agreement with Sandoz Inc. to settle Acura's patent infringement action pending against Sandoz in the United States District Court for the District of Delaware. In the suit, Acura alleges that a generic of Acura's AVERSION® oxycodone product, previously marketed by Pfizer Inc. under its brand name OXECTA®, for which Sandoz is seeking approval to market in the United States pursuant to an Abbreviated New Drug Application (ANDA) filing with the US Food and Drug Administration (FDA) infringes a US patent owned by Acura.
Under the Sandoz Settlement Agreement, Sandoz may launch its generic to the AVERSION® oxycodone product in the US, through the grant of a non-exclusive license from Acura to Sandoz that would trigger 180 days following the first sale of a generic to the AVERSION® oxycodone product in the US by an entity that is entitled to the 180 day first-filer exclusivity under applicable law and FDA regulations (or if no entity is entitled to such 180 day exclusivity period, the date on which a generic to the AVERSION® oxycodone product is first sold in the US). In certain circumstances, Acura's license to Sandoz would become effective prior to such time. Sandoz is not obligated to pay Acura a royalty if its current formulation of its generic to the AVERSION® oxycodone product is approved by the FDA. However, in the event Sandoz changes or modifies the structure of its generic AVERSION® oxycodone product, or materially changes or modifies the amounts or type of any excipient used in the Sandoz formulation disclosed in its ANDA filing with the FDA as of July 30, 2013, Sandoz is required to pay us royalties in the amount of seven percent (7%) of the Net Profits (as defined in the Settlement Agreement) derived from the net sales of such changed or modified Sandoz generic AVERSION® oxycodone product in the United States.
Acura's President and CEO, Bob Jones said, "We are very pleased to have now concluded all our patent infringement suits concerning AVERSION oxycodone. We still await FDA's guidance on what these generic ANDA filers must do to gain approval on a product considered to be equivalent to our AVERSION oxycodone in terms of both efficacy and safety."
The Settlement Agreement provides for a full settlement of all claims that were asserted in the Sandoz suit, subject to the Court's acceptance of the stipulation of dismissal. As required by law, the Settlement Agreement with Sandoz will be submitted to the U.S. Federal Trade Commission and US. Department of Justice.
The Settlement Agreement with Sandoz concludes all of our pending patent infringement litigation against those generic pharmaceutical companies that have filed ANDAs for generic AVERSION® oxycodone products.
On September 20, 2012, we announced that we had received a Paragraph IV Certification notice from a generic sponsor of an ANDA for a generic OXECTA® product. Since such date, we have received similar Paragraph IV Certification notices from four other generic pharmaceutical companies that have filed ANDAs for generic AVERSION® oxycodone products. As a result, on October 31, 2012, we initiated suit against each of Watson Laboratories, Inc. - Florida (Watson), Par Pharmaceutical Inc., Impax Laboratories, Inc. and Sandoz Inc. in the United States District Court for the District of Delaware. On April 29, 2013, we initiated suit against Ranbaxy Pharmaceuticals in the United States District Court for the District of Delaware. In each such litigation, we have alleged infringement of our U.S. Patent No. 7,510,726 listed in the FDA's Orange Book, and having an expiration date in November 2023.
On January 2, 2013, our motion to dismiss the litigation against Watson on the grounds that Watson had amended its ANDA from a Paragraph IV Certification to a Paragraph III Certification, which indicated its intent not to market its generic AVERSION® oxycodone product in advance of our patent expiring, was accepted by the Court. On October 9, 2013 we announced Settlement Agreements with each of Par Pharmaceutical and Impax Laboratories. On May 8, 2014, we announced our Settlement Agreement with Ranbaxy Pharmaceuticals.
Acura Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development and commercialization of product candidates intended to address medication abuse and misuse, utilizing its proprietary AVERSION® and IMPEDE® Technologies. AVERSION® contains polymers that cause the drug to gel when dissolved; it also contains compounds that irritate the nasal passages. IMPEDE® is designed to disrupt the processing of pseudoephedrine from tablets into methamphetamine.
In June 2011, the US Food and Drug Administration approved OXECTA® (oxycodone HC1 tablets) which incorporates the AVERSION® technology. The Company has a development pipeline of additional AVERSION® technology products containing other opioids.