How different can a generic inhaler be to the original?

Iconovo has developed ICOpre, a new generic inhaler platform similar to the well-known Ellipta from GSK. ICOpre is available for pharmaceutical companies who want to go to market when the drug substance expires, rather than wait for inhaler patents of Ellipta to expire in 2030. But what are the pros and cons with going the ICOpre path compared to waiting for Ellipta patents to expire, and how different to the original can a generic inhaler be? The short answer is: it depends.


Why choose a generic inhaler with a unique technology solution?

The first and most obvious reason for considering a generic product is time of launch. Ellipta is protected by its patents until 2030, and is a GSK exclusive. You can either wait another decade before entering this lucrative market segment, or aim for an alternative solution – read an inhaler with the same user handling but based on a unique technology. It’s all about securing freedom to operate, without infringing on patents.

A pure copy-cat inhaler device based on aluminum blisters has the advantage of being built on proven technology, while a new inhaler technology has no track record. On the other hand, if the new technology is approved by authorities there are a number of advantages to benefit from: like proprietary technology, patent opportunities and also a differentiation opportunity. ICOpre is based on the proprietary Linear circle technology developed by Iconovo.


Different regulatory demands

Depending on the market, the regulatory demands on a generic product are different. In Europe it is usually enough to show in-vivo pharmacokinetic equivalence to the reference drug (originator) for the dry powder inhaler with formulation. The inhaler can be operated in a different way than the original inhaler. However, it is a demand that only dry powder inhalers can be replaced with dry powder inhalers and it needs to be the same active molecule(s).

The US is a tougher market. FDA demands formulation equivalence, in-vitro equivalence, in-vivo equivalence on pharmacokinetics, same flow resistance, and same user handling, following exactly the same steps. It must be clinically proven that the generic product has the same effect as the original in patients.

The demands from FDA means that the costs are greater when launching a generic product in the US, but the rewards when approved are also great as it is the world’s largest pharmaceutical market. And a generic approval in the US means that the generic product is directly exchangeable at the pharmacy without permission from the doctor. The potential is huge.


Generic but highly innovative
Iconovo has taken its ICOpre inhaler platform one step further. It shares the easy open-inhale-close handling steps with Ellipta. It has a dose counter, RH protection, is pre-filled with a carrier-based formulation and has the same performance. In addition, ICOpre adds features such as a Load indicator and Inhalation feedback. These visual indicators help the patient feel safer and more confident in using the inhaler.

The ICOpre inhaler platform is in its handling very similar to the original, but has an inside that contains new technology, the proprietary Linear circle technology. Instead of using aluminium blister strips for the formulation, ICOpre utilizes two proprietary injection molded disks with cavities filled with different powder formulation with different APIs, that are opened and inhaled simultaneously. This caters for interesting combination possibilities.

ICOpre does not in any way infringe on the original patents for Ellipta. Instead, it’s an innovative inhaler platform with its own patents pending, enabling new business opportunities for you.