London, 14 February 2019 – Hikma Pharmaceuticals PLC (Hikma, Group) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody’s / BB+ S&P, both stable) announces that Hikma Pharmaceuticals USA Inc., formerly known as West-Ward Pharmaceuticals Corp., has launched Abiraterone Acetate Tablets, 250mg, the generic equivalent to Zytiga®. Abiraterone acetate tablets are a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
In October 2018, the United States District Court for the District of New Jersey’s invalidated a key Zytiga® patent. On 20 November 2018, the United States Court of Appeals for the Federal Circuit denied the patent holder’s request to prevent Hikma’s launching Abiraterone Acetate Tablets pending appeal. Hikma was one of the first ANDA applicants to submit an ANDA with a Paragraph IV certification challenging the validity of certain patents listed for Zytiga® tablets, 250mg, and therefore is eligible for 180 days of generic drug exclusivity.
According to IQVIA, US sales of Abiraterone Acetate Tablets were approximately $1,793 million in the 12 months ending December 2018.
Brian Hoffmann, President, Generics Division, said, “We are adding Abiraterone Acetate Tablets to our oncology portfolio, improving patients access to this life-saving product. This launch continues to demonstrate our ability to successfully litigate paragraph IV products, which is an important element of our portfolio strategy.”