Merck’s Singulair faces generic rivals
pharmafile | August 7, 2012 | News story | Sales and Marketing | Merck, Singulair, generic erosion, patent
Merck has lost patent protection on its biggest selling drug Singulair, opening the floodgates for generic rivals.
Merck’s drug brought in $1.43 billion for the second quarter and is indicated to treat adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.
But Singulair (montelukast sodium) will now be under pressure from 10 generic manufacturers, including Teva and Novartis’ generics unit Sandoz.
All 10 generic firms have applied to sell copies of the tablet form of the drug, with the majority also approved to develop chewable tablets – only Teva has approval for the oral granule form of the drug.
Gregory Geba, director of the office of generic drugs at the FDA, said: “For people who suffer from chronic health conditions such as asthma and allergies, it is important to have effective and affordable treatment options.
“The generic products approved today will expand those options for patients.”
Merck has, of course, been expecting this expiry, and is hoping that sales of its new hep C pill Victrelis will help replace lost revenue from Singulair.
Current estimates see the drug earning $1 billion in peak annual sales, but it is in competition with Janssen’s Incivo for market share, and will not go too far into helping gain back the $5 billion Singular has been bringing each year.
Merck said in its quarterly financials last week that it expects two big filings by the end of next year – insomnia drug suvorexant and odanacatib for osteoporosis – which should also help shore up lost revenue.
Its type II diabetes drug Januvia will soon become its biggest selling drug, having made over $3 billion in sales last year.
Ben Adams
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