March 22, 2023

Glenmark Pharmaceuticals’ US arm has launched the only-approved fixed-dose combination therapy for seasonal allergic rhinitis in the US market. This Ryaltris nasal spray will be distributed by British drug major Hikma Pharmaceuticals.

Brendan O’Grady, chief executive officer (CEO) of Global Formulations Business, Glenmark Pharmaceuticals, told Business Standard that the wholesale acquisition cost price for Ryaltris will be kept around $210.

“Considering the co-pay mechanism until Ryaltris is covered under the insurance, patients will have to pay around $49 out of their pockets,” he added. Glenmark holds the new drug application for Ryaltris in the US.

It will manufacture and supply the product to Hikma, whereas Hikma has the distribution rights for Ryaltris in the US market. “Hikma has a strong footprint in the US as far as the nasal spray/respiratory therapeutic area is concerned. It will also allow Hikma to leverage its existing specialty sales force in the US,” O’Grady said.

In 2018, approximately 24 million people in the US were diagnosed with seasonal allergic rhinitis (hay fever). This accounts for around 8 per cent (19.2 million) of adults and 7 per cent (5.2 million) of children, Glenmark said.

According to a study, the total market size of Allergic Rhinitis therapies in the US is expected to increase at a compound annual growth rate (CAGR) of 3.8 per cent during the study period of 2018-2030.

“At present, there is only one other competing combination, which combines fluticasone propionate with azelastine hydrochloride. It is marketed in some countries by Mylan,” O’Grady told Business Standard.

Glenmark also enjoys a three-year exclusivity period for this drug.

“In addition to the three-year exclusivity period, we also have multiple patents granted in the US, protecting Ryaltris until 2034,” he added.

The Mumbai-headquartered company has chalked out plans to launch Ryaltris in markets across the globe.

“We haven’t filed for Ryaltris in India. So far, we have launched Ryaltris in markets like Australia, the UK, Czech Republic, Poland, Italy, Ireland, South Africa, Russia, Peru, Ecuador, The Philippines and Ukraine,” O’Grady told Business Standard.

He added, “Ryaltris will be launched globally, with successful launches already achieved in the countries mentioned. Ryaltris has moved towards taking a 10 per cent market share in many countries, just over a year after launch in this very congested market.”

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