Endo Wins Order Blocking Generic of Opana ER Until 2023

Updated on

Endo International Plc won a court ruling that will block generic versions of its top-selling painkiller Opana ER, including a version by Actavis Plc that’s already on the market, until two patents expire in 2023.

Actavis has 60 days to comply with the order, U.S. District Judge Thomas P. Griesa in Manhattan said Friday. Griesa said he would decide later whether Actavis would have to pay damages to Endo.

The ruling comes as sales of Endo’s Opana ER have been falling due to competition from generic versions. Griesa’s reasoning is under seal to allow both sides to redact confidential information.

“We are very happy with today’s outcome and are reviewing the ruling in greater detail to determine its long-term impact,” Rajiv De Silva, chief executive officer and president of Endo, said in a statement.

Opana ER is an extended-release prescription drug used to manage severe, chronic pain, such as that faced by some cancer patients.

Endo currently makes a version of Opana ER in a crush-resistant form, which helps prevent abuse of the drug and accounts for more than half of extended-release oxymorphone prescriptions in the U.S., according to Bloomberg Intelligence analyst Aude Gerspacher.

Net sales from Endo’s Opana totaled $90 million through June, down from $101 million in the same period last year, Gerspacher said. Sales “continue to be impacted by competing generic versions,” the company said in an August filing with the Securities and Exchange Commission.

Generic Opana

Actavis’s generic version of Opana ER -- which isn’t crush resistant -- accounts for about 13 percent of prescriptions for such drugs in the country, according to Gerspacher.

David Belian, a spokesman for Actavis, didn’t immediately respond to phone and e-mail requests for comment on the ruling.

Impax Laboratories Inc. also makes a generic version of Opana that accounts for about 33 percent of prescriptions for similar medicines, Gerspacher said. Impax struck a deal with Endo in 2010 to make its generic version, and Griesa didn’t order the company to halt sales of it.

Impax, Teva Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries Ltd. were among the other generic-drug makers involved in the patent litigation. Griesa presided over a nonjury trial that ended in April.