Since April 2025 the MHRA have granted 24 Marketing Authorisation Licenses for Empagliflozin Tablets (10mg and 25mg variants). However, we are currently in legal limbo as patents still exist on the Brand which prevent Generic launch.
We have seen that the Wholesale industry are gradually swapping over from using the Brand name on their price lists and invoices to using the Generic name. We also notice that some Wholesalers are including these products in the Generic price lists, we presume this is in preparation for a potential Generic launch.
One of the things we often do for clients is to look at analogues, which are examples of Generics which have been launched with a similar pre-launch market value. These sometimes give clues as to how quickly market prices will fall after the launch.
The current market value of Jardiance (Empagliflozin) is approximately £158 million a year in England. Past launches of Branded products which weren’t too far from this were Januvia (Sitagliptin) with annual sales in England of £75 million and Xarelto (Rivaroxaban) with annual sales of £212 million. Neither product has precisely the same market value but they give upper and lower estimates of how prices might decay after a Generic launch.
In the graph you will see market prices for multiple presentations of Sitagliptin in orange and Rivaroxaban in green, which give a clue that Empagliflozin could decay very quickly like Rivaroxaban or more slowly like Sitagliptin. In the case of Rivaroxaban, 103 licenses were approved by the MHRA in the five years before launch. For Sitagliptin this number was 55. For Empagliflozin the number of granted licenses is currently 24, which leads us to believe the price decay will be closer to Sitagliptin.
However, we may be discussing this issue far too early, as the launch decision is firmly in the hands of the lawyers and the law courts and could be delayed by months or years.