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Omeros, Sandoz end patent infringement litigation
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A patent infringement lawsuit against Sandoz regarding an abbreviated new drug application for a generic version of Omidria has been dismissed following an agreement between the companies, according to a press release from Omeros.
Sandoz has agreed to amend its ANDA and no longer seek FDA approval to market a generic version of Omeros’ cataract surgery drug until its Orange Book-listed patents expire, the release said.
Omidria (phenylephrine 1% and ketorolac 0.3% intraocular solution) was launched by Omeros in 2015 and Sandoz filed its ANDA 2 years later; with the settlement of the suit, the FDA cannot approve the ANDA until after July 2033, the release said.
Omeros previously settled with other generic developers Par Sterile Products and Par Pharmaceutical as well as Lupin Ltd and its subsidiary Lupin Pharmaceuticals in similar agreements.
“We are pleased that Par, Lupin and now Sandoz have decided to respect our Omidria patents,” George A. Demopulos, MD, chairman and CEO of Omeros, said. “With the favorable resolution of all three generic challenges, Omeros now is planning for nearly 14 years of market exclusivity for Omidria. We look forward to the October 1 reinitiation of CMS’ pass-through status and separate payment for Omidria so that, once again, we can ensure broad access to the drug’s benefits for ophthalmic surgeons and their cataract surgery patients.”