First European sales of generic Tiotropium bromide 18 µg DPI, developed by Phargentis


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In May 2021 the generic Tiotropium bromide 18µg DPI, developed by Phargentis, an agile, small-scale pharmaceutical company headquartered in Lugano, Switzerland, was launched for the first time in Europe - starting with UK and then followed by other markets such as the Netherlands, Norway and Spain. Other markets will follow soon. The generic product has been launched ahead of schedule. With reimbursement agreed in launched countries and ongoing discussions for formal substitution, the generic can be prescribed to COPD patients by healthcare providers as fully substitutable for Spiriva®Handihaler®.

This is the first generic product approved in EU with the same strength (18 µg/capsule) and the same delivered dose (10 µg/capsule) of Spiriva® capsules, plus a device with comparable appearance, handling and performance as the Handihaler® device. Developed by Phargentis it has now been approved in 28 European Countries.

Phargentis CEO Andrea Tam announced: “Our Early Market Entry strategy is a defining strategy for us. Generic drugs offer powerful benefits to society and patients, maintaining lives and outcomes whilst reducing healthcare and social costs. Being able to deliver them at volume is all about achieving market access first. We’re pleased to move ahead in these important markets.”

Phargentis has a portfolio of three Active Development Programs (including Tiotropium bromide DPI) that together address a market value exceeding 3.5b USD. Phargentis is currently planning for market access for its generic Tiotropium bromide DPI in other key international markets.