Supernus Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing and commercializing products for the treatment of CNS diseases, announced that following a seven-day bench trial, Judge Renee Marie Bumb of the United States District Court for the District of New Jersey ruled that Actavis Inc. and its subsidiaries infringed US Patent Nos. 7,722,898 and 7,910,131 by submitting to the FDA an ANDA seeking permission to market a generic version of Oxtellar XR before the expiration of Supernus' patents. Judge Bumb also ruled that US Patent Nos. 7,722,898, 7,910,131, and 8,617,600 are valid. The FDA's Orange Book lists all three patents as expiring on April 13, 2027.
"We are pleased with the court's ruling that Actavis will infringe two of our patents on Oxtellar XR, and the finding that all three patents are valid," stated Jack Khattar, president and chief executive officer of Supernus Pharmaceuticals. "We will continue to vigorously defend our novel products and build upon our strong intellectual property to provide our products the protection they are entitled to."
In addition to the above three patents that were subject to the Federal Court decision, Oxtellar XR is further protected by two other patents that are also listed in the Orange Book and that have an expiration date that is no earlier than 2027. Finally, as of the date of this press release, we are not aware of any FDA approval for the Actavis ANDA.