Orexo receives paragraph IV Notice Letter for ZUBSOLV® in the US
Uppsala, Sweden – August 10, 2020 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), today announces it has received a “paragraph IV” patent certification notice from Sun Pharmaceutical Industries Limited (“Sun”). The Notice Letter advises Orexo of Sun’s filing of an Abbreviated New Drug Application (“ANDA”) with the US Food and Drug Administration (FDA) seeking approval of generic versions of ZUBSOLV® before the expiration of Orexo’s patents listed in the Orange Book. Orexo currently has five patents listed in the Orange Book (US Patent Nos. 8,470,361; 8,658,198; 8,940,330; 9,259,421 and 9,439,
