Saturday, September 6, 2008

When will generics become available for Singulair and Clarinex?

I gave prescription refills for a mother of a child with seasonal allergies. She asked me, "When will generics be available for Singulair and Clarinex?" Good question. I had to look the dates up - please see the table below. The dates will include when the last patent and exclusivity expires, as drugs can be approved for more than one indication and in multiple age groups. To read up on the difference between patent and exclusivity, read this. I did not include any dates for nasal sprays and inhalers for asthma because their situation is more complicated. The inhaler devices must be replicated and demonstrate that they can deliver the medication within the tolerances required. This is a difficult and expensive task. The drugs below are just either coated pills of medications or solutions, not devices + medications. Having said this, with one indication already expired, I wonder when generic drug manufacturers will attack Singulair. It is approved for the treatment of both allergic rhinitis and asthma - one of few medications to be able prove itself capable in clinical trials. It has no real competitors in its class in the marketplace. In the U.S. alone, sales totaled $3.4 billion for 2007. That's good enough for sixth place. (See my earlier post of the rising cost of medications in the U.S.) This is a very large and tempting target. Merck's annual profits are dependent on a blockbuster (defined as greater than $1 billion per year in sales in the U.S. alone) like Singulair. Fortunately for Merck, there was little downside to Singulair until recently. (Please see my post on Singulair and the risk of depression). Recall that sales of Vioxx have ceased and no blockbuster drugs are in Merck's pipeline at present. We shall see what happens during the next four years.

Back to the original question. For patients, it will be several years before generics are available, so if you need the medication, you'll have to pay. Don't forget to read
how to get medications less expensively and efficiently.

MedicationExpiration dateSales rank 2007
Singulair: allergic rhinitis8/27/086
Singulair: exercise-induced asthma4/13/106
Singulair: asthma8/3/126
Clarinex-D 12 Hour and 24 Hour1/7/20?
Allegra-D 12 Hour12/25/20110
Allegra-D 24 Hour5/29/18193

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