Generic Advair Inhalers: 3 Reasons Why It's Taking So Long?
As you may know, Teva’s DuoAir Respiclick was approved by the FDA. It contains the corticosteroid fluticasone and the long acting beta agonist salmeterol, just like Advair. The problem is that the salmeterol dose is less than that of Advair, making it less than ideal.
The question of the day is, why are there not generic advairs on the market that are compatible with the brand product Advair? Also, why is it taking so long to get a generic Advair on the market, especially considering the patent on Advair expired way back in 2010?
First off, we are getting very close to having a fully compatible generic Advair on the market. Sandoz, a division of Novartis, and Hikma Pharmaceuticals, of Jordan, are very close to having fully compatible Advairs to introduce to the FDA for approval. They are “THIS” close.
Still, they have yet to be approved. They are not on the market yet. At least none that are compatible with Advair. Why?
It gets complicated. I will simplify it for you here.
Reason #1: There is more than one patent on Advair
For instance, the patent on the Advair delivery device, the Diskus, did not expire until 2016. To get the product to a patient's airway, you have to have a delivery device that works, and creating one is very expensive. Unlike Metered Dose Inhalers, like albuterol, where the delivery device is relatively the same from one product to the next, Dry Powder Inhaler (DPI) delivery devices differ from one product to the next (assuming the makers of any new Advair go this route).
It's patents on these delivery devices, and other similar patents, that have made getting generic Advair products on the market so complicated. Pharmaceuticals that want to make a generic DPI either have to wait for the Diskus patent to run out, or come up with their own delivery device. Teva decided to go with the Respiclick -- a product they already used for ProAir, their generic version of albuterol.
Reason #2: The chemical components of combination inhalers like Advair are complex
For this reason, it takes a lot of effort and money to make the necessary changes to the formula to get it right. Plus, there also might be necessary tweaks made to the formula to fit any new device, and this also is complicated and costs lots of money.
Plus there's the lawsuits by GSK to protect patents, and whatever studies need to be done to prove efficacy and safety in order to meet FDA standards. And, I'm told, the FDA has some of the highest, strictest, standards to gaining drug approval in the world.
Reason #3: Many pharmaceuticals may consider the risks too great
There are probably a lot of pharmaceuticals that don't even bother trying to make a drug like Advair simply due to the risks involved. Considering all the money that must be spent up front just to be considered by the FDA, a rejection could have catastrophic results for some pharmaceuticals. We don’t want any pharmaceutical to go under, because these companies are necessary to get future asthma medicines on the market.
Conclusion. These are just some of the obstacles that pharmaceuticals have to go through to get a generic asthma inhaler onto the market. Lots of regulations. Lots of costs. Lots of risks. Lots of money. That’s why we might be waiting a while longer for a truly compatible generic Advair.
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