CFC-containing albuterol MDIs were previously exempt from a general ban of CFC production and importation under an international agreement established through the Montreal Protocol on substances that deplete the ozone layer and the US Clean Air Act, as they were considered medically essential with no suitable alternatives.
However, there are now three non-CFC albuterol MDIs approved in the US, which use the more ozone-friendly hydrofluoroalkanes (HFA) as propellants.
The HFA-propelled albuterol MDIs approved in the US are Key Pharmaceuticals' Proventil-HFA, GlaxoSmithKline's Ventolin HFA and IVAX Pharmaceuticals' Easi-Breathe-HFA. Additionally, Sepracor's MDI version of a chiral version of albuterol - Xopenex-HFA (levalbuterol) - has also been approved by the FDA for the treatment or prevention of asthma.
While competition between Sepracor, Key, GSK and IVAX will create some downward pricing of MDIs, from the beginning of 2009, the generic albuterol market will revert back to a branded one. As a consequence, the value of the US inhaled albuterol market is expected to increase from $190 million in 2004 to $400 million by 2009, predicts Datamonitor.
Last year, the FDA said it was concerned that up to a million canisters of albuterol may fail to reach patients after the ban because of price rises. But it now says the companies have committed to a range of access programmes, including MDI giveaways, coupons for reducing the price paid and patient-assistance programs based on financial need, that circumvent this problem.
Fot its part, GSK has committed to freeze the price of Ventolin-HFA until after 2007, at around $40 per MDI, in order to allay concerns that uninsured, low-income patients would cease to use albuterol following the withdrawal of generic versions.
Datamonitor suggests that Key Pharmaceuticals will price Proventil-HFA at around the same level and IVAX will position the Easi-Breathe as a lower-cost, generic-like product, at a lower price-point.
However, IVAX's product, based on the therapeutic equivalent 'BX' rating assigned by the FDA, means it will be marketed as a branded product that will not be substitutable for prescriptions written for Ventolin-HFA or Proventil-HFA. Therefore, although IVAX is a generics manufacturer, the market will not be subject to true generic competition, and the success of products will depend more on factors such as loyalty, experience, features and benefits, rather than price.
Albuterol MDIs are the only products affected by the ban, and inhalers used to deliver other drugs will remain exempt from the prohibition, in stark contrast to Europe where more than 75 per cent of all MDIs have switched to the use of HFA propellants.