Sandoz settles over US Omidria
Executive Summary
Sandoz has agreed not launch a generic rival to Omeros’ Omidria (ketorolac/phenylephrine) injectable ophthalmic drug in the US until patent expiry in 2033, by amending its abbreviated new drug application (ANDA) from a paragraph IV to a paragraph III certification. Originator Omeros has agreed to dismiss prior patent-infringement litigation, with Sandoz’ action meaning it will no longer seek US Food and Drug Administration (FDA) approval to market its proposed generic until all seven Omidria Orange Book patents expire.