Irenas of the United States District Court for the District of New Jersey in the patent infringement lawsuit filed by Horizon against Watson Laboratories, Inc. for an Abbreviated New Drug Application (ANDA) to market a generic version of RAYOS.
A Markman ruling, also known as a Claim Construction Ruling, is a determination by the court of the meaning and scope of disputed patent claim terms of certain patents in suit. Judge Irenas was asked to construe disputed claim terms in U.S. Patent No. 8,394,407 and U.S. Patent No. 8,309,124 and adopted Horizon’s proposed construction of both of the disputed claim terms.
"We are pleased with the Court’s ruling and remain confident that our intellectual property will continue to provide long-term commercial exclusivity for RAYOS," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc.
RAYOS, known as LODOTRA in Europe, is a proprietary delayed-release formulation of low-dose prednisone. The pharmacokinetic profile of RAYOS is different with an approximately four-hour lag time from that of immediate-release prednisone formulations.
In clinical trials studying use of RAYOS in rheumatoid arthritis (RA), patients were administered RAYOS at 10 p.m. with food. The delayed-release profile of RAYOS helps to achieve therapeutic prednisone blood levels at a time point when cytokine levels start rising during the middle of the night.
While the pharmacokinetic profile of RAYOS differs in terms of lag time from immediate-release prednisone, its absorption, distribution and elimination processes are comparable.
Outside the United States, LODOTRA is approved for the treatment of moderate to severe active RA in adults particularly when accompanied by morning stiffness in over thirty-five countries.
Horizon has granted commercialization rights for LODOTRA in Europe, Asia (excluding Japan) and Latin America to its distribution partner Mundipharma International Corporation Limited. Horizon has an exclusive license from Skyepharma for RAYOS/LODOTRA.