GSK’s Advair Loss of Exclusivity (LOE) and Mylan’s Wixela Inhub generic entry

Mylan has launched its generic version of GlaxoSmithKline’s respiratory blockbuster, Advair, at a 70% discount compared with the GlaxoSmithKline’s respiratory blockbuster, Advair. 

Cheaper competition to off-patent Advair has been delayed for years in the US as generic firms struggled to overcome the FDA’s stringent approach to copies of drug-device combination products.

The main patent on Advair (fluticasone+salmeterol) expired as long ago as 2010, while the patent on GSK’s Diskus inhaler expired in 2016.

Mylan’s generic entry: Wixela Inhub

• Mylan became the first of a group of potential competitors to get generics approved last month, and has followed this with a keenly-priced launch.
• All three strengths of the competitor branded as Wixela Inhub will be offered at a wholesale cost of 70% less than Advair Diskus and 67% less than GSK’s authorised generic version, which launched last week.
• The wholesale acquisition costs of Wixela Inhub 100 mcg/50 mcg, 250 mcg/50 mcg and 500 mcg/50 mcg strengths are $93.71, $116.44 and $153.14, respectively.
• However Mylan noted that the wholesale price does not necessarily reflect that paid by consumers, pharmacies, or third-party payers.
• Mylan will also provide patient services to provide training and education about the treatment and device.

Wixela Inhub is indicated for the twice daily treatment of asthma in patients age four and older not adequately controlled on long-term asthma medications or whose disease warrants initiation of treatment with both inhaled corticosteroids and long-acting beta agonists.

It is also approved for maintenance treatment of chronic obstructive pulmonary disease (COPD) and the reduction of COPD exacerbations in patients with a history of exacerbations. It is not indicated for the relief of acute bronchospasm.