As can be seen from the table above, there are several Ellipta® products where the drug patent will expire earlier than the device patent, opening an opportunity for companies that can launch a generic product without infringing on Ellipta® intellectual property. The patent landscape is different in different geographies.
The regulatory requirements are different between the European regulations (EMA) and the US regulations (FDA). Regulators in both territories demand that only products with the same formulation type can be approved as a generic alternative, meaning that only dry powder inhalers can be approved as generic alternatives to originator dry powder inhalers. In Europe, the operation of the device can be different from the originator operation, while FDA has a demand for the generic inhaler to operate in a similar way. A term like “similar operation” will always leave room for interpretation by regulatory authorities adding risk to the development. In Europe, you can usually get approval by showing equivalence on several in vitro device parameters and a pharmacokinetic equivalence trial, while in the US, you also need a pharmacodynamic clinical trial showing equivalence. It means that the regulatory pathway in the US has higher demands to claim bioequivalence than the European pathway, thereby also being more risky and costly. However, the value of the US market is significant, and the higher regulatory hurdles should also mean less intense competition in the marketplace.
ICOpre – pre-metered dual cavity multi-dose dry powder inhaler
ICOpre is a pre-metered dual cavity dry powder inhaler with 30 individually sealed doses protected by aluminum foil. It features the same easy, three-step user operation as the well-known Ellipta®, Open-Inhale-Close. Each dose comes from two compartments that are inhaled simultaneously, which makes ICOpre suitable for mono, duo or triple products. A dose counter makes it easy to see the number of remaining doses. ICOpre is color-coded according to the substance and strength.