FDA licenses versions of the brand from Teva, Sandoz, Aurobindo Pharma and others
The Food and Drug Administration (FDA) has approved the first generic versions of Merck & Co's blockbuster asthma and allergy drug Singulair.
The US regulator granted ten companies licences to market their own version of Singulair (motelukast) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.
Gregory Geba, director of the Office of Generic Drugs in FDA's Center for Drug Evaluation and Research, 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 will expand those options for patients.”
Montelukast is a leukotriene receptor antagonist and blocks leukotrienes; the substance that causes asthma and hay fever (allergic rhinitis) symptoms.
But the approval of a swathe of generic competitors in the world's biggest pharma market is sure to decimate Merck's sales.
The FDA licensed generic motelukast tablets from Apotex, Aurobindo Pharma, Endo Pharmaceuticals, Glenmark Generics, Kudco Ireland, Mylan, Roxane Laboratories, Sandoz, Teva Pharmaceuticals and Torrent Pharmaceuticals.
The regulator also gave the go-ahead for chewable tablets from Apotex, Aurobindo, Endo, Kudco, Mylan, Roxane, Sandoz, Teva, and Torrent, and an oral granule form of the drug from Teva.
Montelukast Sodium Tablets, 10 mg, had US sales of approximately $3.7bn for the 12 months ending June 30, 2012, and Montelukast Sodium Chewable Tablets, 4 mg and 5 mg, had US sales of approximately $1.2bn for the 12 months ending June 30, 2012, according to IMS Health.
Generic prescribing in the US last year saw its largest year-on-year increase since 1998 according to another IMS study that found nearly 80 per cent of prescriptions in the country are now written generically.