When Can We Expect A Generic Advair?

John Bottrell Health Pro
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    When word got out that the U.S. patent for Advair was going to expire in 2010, there was a lot of buzz in the asthma/ COPD community. The hope was that this would lead to a generic Advair, and, therefore, a lower price. Yet that was four years ago and there is still no generic. So, when can we expect one?

     

    Advair is a combination drug with both the inhaled steroid fluticasone and the long acting beta adrenergic salmeterol.  It was the first medicine of it's kind, and continues to be the second best-selling drug in the world, grossing around $8 billion a year for the London based GlaxoSmithKline (GSK).  

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    While called Advair in the U.S., the product is known as Seritide in Australia, most European countries, Mexico, New Zealand, South Africa, and South Korea. 
    It is known as Viani in Germany, Adoair in Japan, and Foxair in South Africa.
     
    Doses of Advair are noted as fluticasone/serevent: 
    • 100/50 (approved by the FDA in 2003 for ages 4 and up)
    • 250/50 (approved by the FDA in 2000 for ages 12 and up)
    • 500/50 (approved by the FDA in 2000 for ages 12 and up)
    • Advair HFA (approved by FDA in 2006)

    The price for Advair continues to be high.  For instance, my copay for a 250/50 Advair Discuss I purchased on January 25, 2014 was $61 for a one month supply, which comes to $720 per year. Without insurance the product would cost $246.28, which comes to $3,000 per year. 

     

    The cost of the 100/50 Advair Discuss would be about $40 with a copay, and the 500/50 Advair Discus is $80 with a copay.  

     

    These are the prices at the Spectrum Health Ludington Hospital in Ludington, Michigan. After calling around to the various other pharmacies in this area I found the price to be similar.  Depending on where you live and what insurance company you use, the prices for Advair in your area may vary.  

     

    So, since the patent on Advair expired in 2010, why is there still no generic on the market?  Well, the reason for this is actually quite complicated. 

     

    One reason is because the medicine is a combination of a complex formula, and once a generic version is available it has to be run through a gamut of tests, and then has to be approved by the FDA.  

     

    A second reason why there is still no generic Advair on the market is because, while the U.S. patent on Advair the medicine has expired, the U.S. patent on the purple Advair Discuss does not expire until 2016.  

     

    So, unless a generic company can somehow invent a new Advair delivery device — a task that has proven to be very complicated and expensive — they will have to wait until the Advair Discuss patent expires before they can market their product.  

     

    The patent in some countries has already expired, and so you can find a generic Advair in some locations around the world.  In fact, you can purchase Advair at a lower price, or a generic Advair at an even lower price, at certain Canadian pharmacies. 

     

    The European patent was set to expire in 2013 in most European countries. Reuters reported in December 2013, that Denmark was the first to approve a generic Advair in Europe. The product is called AirFluSal Forspiro. 

     

    Reuters said that "The green light marks the first approval of the product in Europe and analysts said more European approvals were likely to follow, with other Nordic countries and Germany seen among initial markets."

     

    There is excitement that this or a similar product will be approved for sale elsewhere in Europe by 2017.

     

    The best market for Advair, however, is the United States.  There is presently at least one generic company attempting to obtain a piece of the profitable Advair market in the U.S. by tackling hurdles.  The product will most likely not be available until 2016, if not later. 

     

    Since the drug is so profitable in a very difficult market, GSK will do anything and everything in its power to prevent competition.  

     

    Yet the FDA seems to be on the side of generic companies and consumers.

    According to cnbc.com and Reuters, the FDA recently changed the guidelines to make it easier for a complicated product like Advair to reach FDA approval.

     

    Also, said Reuters, "the FDA is only looking for data from an asthma trial, even though Advair is also used in chronic obstructive pulmonary disease (COPD)." 

     

    This has apparently increased optimism that a generic Advair product will be available in the U.S. by 2016, signified by recent declines in GSK shares. 

     

    Generic medicine has the same chemical composition as brand named product, and it should work just as well.  Once a generic product is available, pharmacies will be allowed to automatically swap the brand product Advair with a generic Advair in order to save the customer money.  
     

    In this way, the increased competition from generic Advair products will greatly reduce the price of the product across the board.  

     

    In the meantime, and in most countries around the globe,  asthma and COPD patients will be forced to pay premium prices for a product proven to improve lung function.  
Published On: January 25, 2014