Omeros Corporation has filed patent infringement lawsuits against Par Pharmaceutical, Inc. and its subsidiary, Par Sterile Products, LLC. The lawsuits were filed under the Hatch-Waxman Act for Par’s infringement of three Omeros patents relating to Omeros’ drug Omidria@ (phenylephrine and ketorolac injection) 1%/0.3%, which are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book, published by the U.S. Food and Drug Administration (“FDA”).
The lawsuits were filed in response to a certification notice Omeros received from Par on July 23 regarding Par’s filing with the FDA of an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of Omidria prior to the expiration of the three Orange Book-listed patents.
Under the Hatch-Waxman Act, Omeros was permitted to file suit within 45 days from its receipt of Par’s notice and thereby trigger a 30-month stay of the FDA’s approval of Par’s ANDA. The stay is expected to remain in effect until March 2018. Omeros has reviewed Par’s Paragraph IV assertions and believes they do not have merit.
Omeros has sought access to Par’s ANDA, which Par is legally required to provide under reasonable terms, but to date Par has not provided this access. Omidria contains the mydriatic (pupil-dilating) agent phenylephrine and the anti-inflammatory agent ketorolac and was developed for use during cataract or other IOL replacement surgery.
