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FDA approves generics of Merck’s Singulair Posted 10/08/2012

FDA announced on 3 August 2012 that the agency had approved not one, but ten generic versions of Merck’s blockbuster asthma-allergy drug Singulair (montelukast).

Apotex, Aurobindo Pharma (Aurobindo), Endo Pharmaceuticals (Endo), Glenmark Generics, Kudco Ireland, Mylan, Roxane Laboratories, Sandoz, Teva Pharmaceuticals (Teva) and Torrent Pharmaceuticals (Torrent) gained FDA approval for generic montelukast tablets. Apotex, Aurobindo, Endo, Kudco, Mylan, Roxane, Sandoz, Teva and Torrent have received approval for chewable tablets. Teva also received approval for the oral granule form.

Montelukast is in a class of medications called leukotriene receptor antagonists. It works by blocking the action of leukotrienes, substances in the body that cause the symptoms of asthma and hay fever (allergic rhinitis). The generics have been approved for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.

Mr Gregory P Geba, Director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research said that ‘for people who suffer from chronic health conditions such as asthma and allergies, it is important to have effective and affordable treatment options.’ Adding that the approved generic products would ‘expand those options for patients’.

Merck’s worldwide sales for Singulair in 2011 were US$5.5 billion, representing a 10% increase compared with 2010. The company expects a significant decline in Singulair sales following expiry of the US patent, but Merck is relying on its pipeline to help weather the loss of patent protection to Singulair, and has six projects due to reach the marketing application stage in the next 18 months.

Although the European patents on Singulair were also set to expire in August 2012, Merck has gained a paediatric extension until February 2013 in France, Germany and the UK, as well as in many smaller markets. In Australia, an extension on the molecule patent means that the patent will only expire in April 2013, while in Canada patents already expired in October 2011.

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Source: FDA, Merck

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