Xspray conducts two kinds of product strategies. The first is to develop, so-called generic drugs, pharmaceutically and therapeutically equivalent versions of previously approved products, where there exist “patent windows” and the product may be sold semi-exclusive parallel with the original drug. In the US market, such a product can be registered by a simplified application for registration (ANDA), section 505 (j) of Federal Food, Drug and Cosmetic Act.
The second strategy is to develop improved versions of previously approved products where it can be sold semi-exclusively next to the original drug. In the US market, such a product may be registered under section 505 (b) (2) of the Federal Food, Drug and Cosmetic Act.
The company strives to invest in orphan designation drugs. This is because they often have a high pricing, which means that the effect of attractive pricing can be expected to greatly affect the market share and secure a rapid market penetration.
Xspray’s clinical trial programmes on healthy volunteers have been adequately identified by FDA. This means lower R&D costs and less time developing as studies on patients are significantly more expensive and take considerably more time. Xspray’s product candidates can therefore be expected to have a straight and short way to the market.