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Omeros Announces Voluntary Dismissal Of Infringement Suit Against Sandoz

Omeros Corp. (OMER) said that its patent infringement lawsuit against Sandoz Inc. has been dismissed by stipulation of the parties.

The lawsuit concerns Sandoz's Abbreviated New Drug Application or ANDA, which sought approval from the U.S. Food and Drug Administration to market a generic version of Omeros' cataract surgery drug OMIDRIA (phenylephrine and ketorolac intraocular solution).

Omeros said it agreed to the dismissal of the lawsuit as 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, amid 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.

However, 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.

"We are pleased that Par, Lupin and now Sandoz have decided to respect our OMIDRIA patents. With the favorable resolution of all three generic challenges, Omeros now is planning for nearly 14 years of market exclusivity for OMIDRIA," Gregory Demopulos, chairman and chief executive officer of Omeros said.

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