Glenmark gets tentative US FDA approval for asthma drug

Glenmark Generics Inc USA has received a tentative US FDA approval for its drug Montelukast Sodium 10 mg tablets. This formulation is currently sold exclusively by Merck & Company in the US market under the name Singulair. Merck & Company currently holds the patent for this drug, which will expire in August 2012. Glenmark will market the generic version of this brand once the patent expires.

Montelukast Sodium is used for the Prophylaxis and Treatment of asthma. It is also used for the prevention of exercise-induced-bronchoconstrictoin and allergic rhinitis. 

To understand the market size of this product, we at DSIJ analyzed the annual report of Merck & Company. Singulair, is the company’s blockbuster brand in the US for this formulation that raked in about USD 3.2 billion in revenues in the year 2010. Merck and Company expects the sales of Singulair to drop after the expiry of the patent. The patent for Singulair will also expire in European markets in August 2012, which will provide an opportunity to other companies looking to enter the European market. 

Asthma is a lifelong disease. According to a report published on CDC.gov (Centre for disease control and prevention) dated May 3, 2011 the number of Americans diagnosed with asthma grew by 4.3 million from 2001 to 2009. The report also indicates that a total of 8 per cent of American population is asthmatic. It also reports that 10 per cent of children and 12 per cent of adults were suffering from asthma in 2009. About 40% uninsured and 11% insured asthmatic people could not afford the prescription medicines prescribed for Asthma.

One can see that there is a good opportunity to tap this market. Generics drugs are usually sold at lower prices and hence we believe that Glenmark will be in a good position once the patent expires.

It is also learnt that Mylan Pharma, a US based pharma company also received US FDA approval for this drug in 2009 and is awaiting the launch of the generic version in August 2012.