London, 10 June 2019 – Hikma Pharmaceuticals PLC (Hikma, Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody’s / BB+ S&P, both stable) the multinational pharmaceutical company, has launched Bosentan Tablets, 62.5mg and 125mg, the generic equivalent to Tracleer® , in the United States through its US affiliate, Hikma Pharmaceuticals USA Inc.
Hikma’s Bosentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%).
In 2018 Actelion’s US sales of Tracleer® (bosentan) were $268 million.
Brian Hoffmann, President of Generics said, “We are pleased to add Bosentan Tablets to our US portfolio. This demonstrates our ability to develop technically challenging, differentiated medicines that address health issues impacting a growing number of people, bringing greater value to our customers and patients across the US.”
 In 2017, Actelion Pharmaceuticals Ltd. was acquired by Johnson & Johnson. Sales figures were sourced from Johnson & Johnson’s 2018 annual report.