September FDA draft guidance looked like it could make it easier for generics of GlaxoSmithKline’s asthma/COPD medication Advair to hit the market. The issue at the time was that the guidance indicated generics rivals could bypass human trials in their pursuit of regulatory approval.
The guidance, however, does not address a mechanical challenge, which is the complexity of the inhaler itself, for which GSK has a patent until 2016.
The new news: Teva announced on Tuesday that it does not expect to drop its generic Advair into the US market for at least another five years, reports Reuters, noting that this delay insulates GSK’s $8 billion-a-year money maker for a while longer. It also buys more time for GSK COPD drug Breo Ellipta—Ellipta is the inhaler—to gain traction. The FDA approved Breo Ellipta in May.
