Like I said: Advair Diskus too hard to copy

Generics maker Teva confirmed it doesn’t expect to bring a generic version of Advair to market before 2018, even though patents are expiring sooner. The reason for the delay: the inhaler device is too hard to replicate.

As I wrote last month (How a tough manufacturing process for Advair might help GSK):

Unlike the typical round, white pill, its complex inhaler mechanism was never designed to be produced in huge quantities in multiple locations around the world, where different environmental conditions and variations in raw materials could make it hard to duplicate. So manufacturing has been a challenge for GSK and consumed plenty of resources…

So ironically, due to GSK’s inability to anticipate the high demand for Advair and develop an easier-to-make device, the company is now benefiting from a much stronger barrier to entry on its lead product than it could ever have imagined or hoped for.

GSK got incredibly lucky with Advair. It now looks like that luck will continue.

By David E. Williams of the Health Business Group.

One thought on “Like I said: Advair Diskus too hard to copy”

  1. What constitutes “hard to manufacture”? The extreme rules of the FDA strongly favor very large companies. A dry powder inhaler is an inferior device with a guarantee to outdate in a few weeks if opened — Advair should be taken off the market. Inhalers are inhalers, not the space shuttle. Keep in mind generic manufacturers are often paid not to make certain products and are also threatened by frivolous but very expensive legal action if they don’t bend to the will of big pharma.

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