Currently, there are only three drugs on the US market - Rivaroxaban (Bayer and J & J), Apixaban (Pfizer and Bristol-Myers Squibb) and Edoxaban (Daiichi Sankyo), relating to anticoagulants, direct factor Xa inhibitors and one drug (Dabigatran, Boehringer Ingelheim), relating to anticoagulants, direct thrombin inhibitors. These drugs share the market of modern anticoagulants in the USA. Due to the fact, that the FDA initiated an investigation with reference of lethal cases after bleeding caused by the use of Dabigatran, its sales do not grow. In spite of the fact that Eliquis (Apixaban) entered the market with an annual delay with respect to Xarelto (Rivaroxaban), its sales grow faster and it is probably connected with the best safety profile with respect to Xarelto, although it suffers from inconvenience of administration (twice a day, not once a day, like Xarelto).
Quarterly sales of anticoagulants of new generation.
Estimation of the potential market volume:
The drug being developed is primarily intended to be prescribed to patients on indications of prevention of venous thromboembolism after the knee or hip replacement surgeries, since it is the easiest to conduct clinical trials on these indications. Then, it is planned to enter the market of drugs on indications of prevention of pulmonary thromboembolism and prevention of stroke in patients with atrial fibrillation, as clinical trials for these indications will take longer and will require more financial resources.
Currently, 4 preparations related to NOACs are registered in the USA, EU, RF: Rivaroxaban (Bayer and J & J), Apixaban (Pfizer and Bristol-Myers Squibb) and Edoxaban (Daiichi Sankyo), relating to anticoagulants, direct factor Xa inhibitors and one drug Dabigatran (Boehringer Ingelheim) direct thrombin inhibitor.
Since patients with increased thrombus formation and risk of embolism are found in all countries, our position in determination of geographic priorities was to copy the Bayer solution for patenting of the Rivaroxaban anticoagulant. Like Bayer, we limited ourselves to patenting in the CIS countries, the Eurozone, the USA and 12 the most developed and most populated countries. Most likely, that our priority will be the market of the CIS countries, since it seems to us that bringing the drug to the market stage is easier here.