Omeros Corporation said it entered into a settlement agreement with Par Pharmaceutical, Inc. and its subsidiary Par Sterile Products, LLC that resolves Omeros’ patent litigation against Par.
The litigation concerned Par’s filing of an Abbreviated New Drug Application (ANDA) seeking approval from the US Food and Drug Administration (FDA) to market a generic version of Omeros’ commercial drug Omidria — a drug for use in cataract and lens replacement surgeries.
“In the settlement, Par, which had previously stipulated to infringement, acknowledges and confirms the validity of all asserted patents for Omidria,” said Omeros.
“The settlement includes a consent judgment filed with the U.S. District Court for the District of Delaware.
“Unless subsequently authorized pursuant to terms in the settlement agreement, Par will be prohibited by the judgment from launching a generic version of Omidria until April 1, 2032.
“The last-to-expire of Omeros’ Orange Book listed patents for Omidria expires on October 23, 2033.
“As part of the settlement agreement, if and when Par eventually enters the market, Par will pay to Omeros a royalty of 15 percent of Par’s net sales of any generic version of Omidria until the latest expiration of Omeros’ U.S. Patents related to Omidria.”
Omeros CEO Gregory Demopulos said: “We are pleased with this settlement and what it represents to our company and its shareholders.
“The settlement affirms our belief in the strength of our patents for Omidria.
“Sales of Omidria continue to grow as more and more facilities and surgeons incorporate the product into their cataract surgery routines, improving postoperative outcomes for their patients.”