How to overcome the 'double-lock' barrier to entry for generic inhalers

In the pharmaceutical industry, a good opportunity is generally one that provides sustainable cash flows, is worth a significant amount of money and provides barriers against competition. The asthma and COPD market is one that meets these criteria and the race is on amongst branded generic (BGx) / generic (Gx) manufacturers to enter the market, which will be worth $24.5bn by 2020 in EU5 and US. In 2014, the leading products Advair (fluticasone+salmeterol) and Symbicort (budesonide+formoterol) generated $5.9bn and $2.9bn respectively. These products have sustained commercial success despite the active molecules being off-patent. The molecule patent for Advair either expired or was revoked in the US and 5EU markets in 2010. For Symbicort, the primary patent in the 5EU expired in 2012 and in the US in 2014.

Setting the scene