The US patent is expected to expire on October 30, 2022 and, in addition, the US PTO has granted a patent term adjustment of 300 days, leading to an effective expiration date of August 26, 2023.
The oral formulation is marketed in the US under the tradename Fanapt by Novartis Pharmaceuticals pursuant to an agreement between Vanda and Novartis Pharma, which was entered into on October 12, 2009.
Reportedly, Novartis is responsible for the commercialisation and further clinical development activities of Fanapt in the US and Canada, including the development and commercialisation of the long-acting injectable (or depot) formulation of Fanapt. Vanda retains rights to commercialise Fanapt oral and depot formulations outside the US and Canada.