Aiming to enable launch of its innovative nasal spray in 17 countries in the European Union, Glenmark Pharmaceuticals Limited is concluding the final phase of its marketing approval application process. Ryaltris, developed by Glenmark, is a novel fixed-dose combination nasal spray of an anti-histamine and a steroid, indicated for treatment of symptoms associated with allergic rhinitis (AR) in patients over 12 years of age.
Ryaltris will shortly be available in Austria, Belgium, Czech Republic, Germany, Denmark, Spain, Finland, France, Ireland, Italy, The Netherlands, Norway, Poland, Romania, Slovakia, Sweden, and the UK. Glenmark will commercialise Ryaltris on its own in select markets. In some countries such as France, Italy, Spain and the Balkan region, Menarini Group will lead the commercialisation effort, as part of an exclusive licensing agreement signed with Glenmark.
For commercialization of Ryaltris in the US and Canada, Glenmark has also partnered with Hikma Pharmaceuticals PLC and Bausch Health. Ryaltris sales continue to progress well in Australia, after the successful launch in 2020 by Glenmark’s partner, Seqirus Pty. Ltd. Ryaltris was also recently launched in South Africa, Ukraine and Uzbekistan. Ryaltris is currently under regulatory review in Canada, Brazil, Malaysia, Saudi Arabia and several other markets. So far, Glenmark has received approval for Ryaltris in Australia, South Korea, Cambodia, Ukraine, Uzbekistan, Namibia, Russia, South Africa, and Ecuador.
