Hikma Pharmaceuticals has launched Ryaltris olopatadine / mometasone nasal spray in the US, the company said. Hikma acquired US rights to Ryaltris in February 2020, and the FDA approved Glenmark’s NDA for the nasal spray for the treatment of seasonal allergic rhinitis in January 2022.
The company’s US catalog includes several other nasal sprays, including fluticasone propionate, dihydroergotamine (DHE), and butorphanol. Hikma’s Kloxxado naloxone nasal spray was approved by the FDA in April 2021. Hikma acquired the naloxone nasal spray along with an epinephrine nasal spray and unit-dose nasal spray manufacturing capabilities from Insys Therapeutics in August 2019.
Hikma Generics President Brian Hoffmann commented, “The launch of Ryaltris is a significant step forward for Hikma in expanding our US nasal spray leadership into branded medicines and advancing our objective of growing our specialty business in the US. Importantly, it will allow us to leverage our strong, existing specialty salesforce already calling on doctors within our specialty portfolio. We look forward to bringing this important new treatment option to the millions of US patients suffering from seasonal allergic rhinitis.”
Glenmark CEO, Global Formulations Business, Brendan O’Grady said, “We are delighted to partner with Hikma for the launch of our novel drug Ryaltris in the United States, making it our first global branded specialty product to be marketed in the country. Ryaltris is a result of our consistent efforts to offer high-quality medicines that benefit patients around the world. Available in major markets across the globe, this launch is a major milestone for Glenmark and demonstrates our focus in strengthening our global respiratory leadership.”
Read the Hikma press release.
