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30 July 2018Americas

Sandoz agrees to drop generic in Omeros clash

Sandoz has agreed to postpone its generic version of a cataract surgery drug made by biopharmaceutical company Omeros, ending a patent infringement lawsuit between the two in Delaware.

Omeros announced the agreement on Thursday, July 26, the day after District Judge Richard Andrews of the US District Court for the District of Delaware dismissed the case.

Back in June last year, Omeros had accused Sandoz of infringing its patents covering Omidria (phenylephrine and ketorolac), after Sandoz filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA) to market a generic version of the drug.

Omeros launched Omidria in 2015, two years before Sandoz submitted its ANDA.

All of Omeros’s pending litigation with ANDA filers has now been concluded after the company announced it had settled lawsuits with Par Pharmaceutical and Lupin.

Based on the three settlement agreements, the earliest ANDA entry date for any of the generic manufacturers is April 2032, unless a generic is subsequently authorised.

Gregory Demopulos, chairman and CEO of Omeros, said: “With the favourable resolution of all three generic challenges, Omeros now is planning for nearly 14 years of market exclusivity for Omidria.”

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More on this story

Americas
23 June 2017   Biopharmaceutical company Omeros has filed a complaint against Sandoz for allegedly infringing its patent covering Omidria.
Americas
7 September 2015   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 product.

More on this story

Americas
23 June 2017   Biopharmaceutical company Omeros has filed a complaint against Sandoz for allegedly infringing its patent covering Omidria.
Americas
7 September 2015   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 product.

More on this story

Americas
23 June 2017   Biopharmaceutical company Omeros has filed a complaint against Sandoz for allegedly infringing its patent covering Omidria.
Americas
7 September 2015   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 product.