Omeros cries foul over Par’s eye drug ANDA

Biopharmaceutical company Omeros has hit its competitor Par Pharmaceutical with two lawsuits at US district courts over the drug company’s attempt to market a generic version of its Omidria (phenylephrine and ketorolac injection) product.

Omeros filed a lawsuit at the US District Court for the District of New Jersey on September 2 and at the US District Court for the District of Delaware a day later.

Both lawsuits concern the alleged the infringement of three patents owned by Omeros which cover its eye treatment drug Omidria.

Last month, Omeros reported that Omidria had generated  just more than $3 million in sales in the second quarter of 2015.

Omeros’s lawsuits were filed after Par Sterile Products, a subsidiary of Par, notified the biopharma company in July of its plan to file an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA).

In the same notice, Par stated that US patent numbers 8,173,707, 8,586,633 and 9,066,856 are invalid and would not be infringed by its ANDA.

Following the filing of the lawsuits, a 30-month stay has now been implemented preventing the FDA from approving the ANDA.

Omeros is seeking a judgment that Par’s ANDA is infringing its patents and a permanent injunction against Par’s generic version of the drug.