- Sandoz's ANDA cannot be approved until after all patents expire in 2033
- Omeros previously settled lawsuits against Par and Lupin
Omeros Corporation (Nasdaq: OMER) announced on 7/26/18 that its patent infringement lawsuit against Sandoz Inc. (Sandoz) concerning Sandoz’s Abbreviated New Drug Application (ANDA), which sought approval from the U.S. Food and Drug Administration (FDA) to market a generic version of Omeros’ cataract surgery drug Omidria (phenylephrine and ketorolac intraocular solution) 1% / 0.3%, has been dismissed by stipulation of the parties. Omeros agreed to the dismissal because Sandoz amended its ANDA to no longer seek FDA approval to market its proposed generic drug prior to the expiration of all of Omeros’ Orange Book-listed patents for OMIDRIA. The latest expiry date of these patents is July 2033.
Omeros commercially launched Omidria, the only FDA-approved product of its kind, in 2015. Two years later, in the setting of steadily increasing Omidria sales, Omeros received a Paragraph IV certification from Sandoz in connection with Sandoz’s ANDA filing for a generic version of Omidria. Omeros responded with patent infringement litigation against Sandoz. Sandoz has now converted to a Paragraph III certification, which means that FDA cannot approve the ANDA until after the July 2033 expiry of all patents listed in the Orange Book for Omidria, namely U.S. Patent No. 8,173,707, U.S. Patent No. 8,586,633, U.S. Patent No. 9,066,856, U.S. Patent No. 9,278,101, U.S. Patent No. 9,399,040, U.S. Patent No. 9,486,406, and U.S. Patent No. 9,855,246.
With Sandoz’ conversion to a Paragraph III certification and Omeros’ agreement to dismiss its patent infringement litigation against Sandoz, all of Omeros’ pending litigation with ANDA filers has been concluded. Omeros previously announced that it had settled lawsuits against two other ANDA filers – Par Sterile Products, LLC and Par Pharmaceutical, Inc. (Par) and Lupin Ltd. and its subsidiary Lupin Pharmaceuticals, Inc. (Lupin). Based on these settlement agreements, the earliest ANDA entry date for any of the three generic manufacturers is April 2032 unless otherwise subsequently authorized pursuant to the settlement agreements.
“We are pleased that Par, Lupin and now Sandoz have decided to respect our Omidria patents,” stated Gregory A. Demopulos M.D., chairman and chief executive officer of Omeros. “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 re-initiation 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.”
In addition to Omidria, Omeros has 11 other therapies in various stages of development.