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Omeros settles Omidria patent infringement suit against Par

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Par Pharmaceutical will have to wait until 2032 to begin marketing a generic version of Omeros’ Omidria, according to a settlement the two companies agreed to after a 3-day trial.

Omeros sued Par after the latter company filed an abbreviated new drug application with the FDA in 2015 to market a generic version of Omidria (phenylephrine 1% and ketorolac 0.3% injection), a press release from Omeros said. The company claimed Par would infringe on its Orange Book-listed patents by marketing a generic version.

Under the terms of the settlement agreement, Par acknowledges and confirms the validity of the Omidria patents and is prohibited from marketing a generic version until April 1, 2032. In addition, if and when the company does market a generic version, Par will pay Omeros a 15% royalty of any net sales of any generic version of the drug until Oct. 23, 2033 – the last expiration date for Omidria’s patents.

“We are pleased with this settlement and what it represents to our company and its shareholders,” Gregory A. Demopulos, MD, chairman and CEO of Omeros, said in the release. “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.”