The agreement resolves the patent litigation commenced in 2020 by Orexo following Sun’s filing of an Abbreviated New Drug Application (ANDA) seeking approval to market generic versions of Zubsolv in the US prior to the expiration of Orexo’s patents listed in FDA’s Orange Book for Zubsolv.

Enter the US market in 2030

The agreement allows Sun to enter the US market with its generic versions of Zubsolv in September 2030. Zubsolv is protected by ten patents in the US with expiration dates ranging from 2027 to 2032. This settlement agreement does not implicate its patent protection.