Boston, MA -- (SBWIRE) -- 03/17/2014 -- There are over 30 million people suffering from seasonal asthma of different levels worldwide, and the situation is worse in deeply contaminated countries and regions with high tobacco consumption. Asthma and allergic rhinitis are both very common diseases in the world today. As the atmosphere becomes more seriously contaminated, incidence of these diseases increases year by year.
Montelukast, developed by MSD Co., Ltd., is widely used in curing allergic rhinitis and asthma. Montelukast is a CysLT1 antagonist that blocks the action of leukotriene D4 on the cysteinyl leukotriene receptor CysLT1 in the lungs and bronchial tubes by binding to it. This reduces the bronchoconstriction otherwise caused by the leukotriene and results in less inflammation.
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In 1998, montelukast sodium tablets (10mg) and chewable tablets (5mg) were approved by FDA to the market with the trade name "Singulair". In 2000 and 2002, montelukast chewable tablets (4mg) and montelukast granules (4mg) were approved to the market in turn. They are mainly used in prevention and long-term treatment of asthma of adult and children aged two and above.
Patent of Singulair in U.S. expired on August 3, 2012. Hereafter, FDA approved over 10 manufacturers' applications for their generic drugs to the market. Among them, Teva Pharmaceutical Industries Limited launched tablets, chewable tablets and oral granules while Dr. Reddy's Laboratories Ltd. launched tablets and chewable tablets. In 2012, due to the generic drug intrusion, sales revenue of Singulair produced by MSD Co., Ltd. dropped to USD 3,853 million, decreased by 30%.
In 1999, montelukast chewable tablets (5mg) and tablets (10mg) produced by MSD Co., Ltd. were allowed to enter China with the trade name "Singulair". Hereafter, montelukast chewable tablets (4mg) and granules (4mg) were permitted into Chinese market sequentially. Generic montelukast tablets (10mg) and chewable tablets (5mg) produced by Sichuan Otsuka Pharmaceutical Co., Ltd. were approved to the market in 2006 with the trade name "Bai Sanping". Mudanjiang Hengyuan Pharmaceutical Co., Ltd. was the first manufacturer that acquired approval of montelukast sodium raw material production in 2006. In 2008, Lunan Better Pharmaceutical Co., LTD. was given the approval of montelukast tablets (10mg) and chewable tablets (5mg). In addition, many drug manufacturers such as YZJ Group and Beijing Winsunny Pharmaceutical Company Limited have applied for generic drugs production.
According to CRI's investigation on certain sample hospital market in China, the CAGR of sales value of montelukast surpassed 45% from 2005 to 2010. As more competitors entered the market, Chinese montelukast market growth has slowed down since 2011. However, an annual growth rate of 10% is still maintained.
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