Boston, MA -- (SBWIRE) -- 03/24/2014 -- Depression is a common mood disorder that belongs to high-incidence mental diseases worldwide. Its main clinical features are a state of low mood and aversion to activity, and sometimes even suicidal thoughts or behaviors.
According to statistics from World Health Organization (WHO), depression is one of the most disabling diseases in the world today with over 0.3 billion sufferers worldwide. Because there are 10 to 20 million patients with suicidal thoughts every year in the world, it is said that 21 century is a "Century of Depression". China is going through social transformation, which is also a period with high incidence of psychological problems. Statistics shows that there are more than 30 million depression patients now in China, of which over 80% have never been treated because of low income or other issues. Depression patients take up 50% to 70% of suicides and attempted suicides in China. Obviously, depression has become a major social problem in China.
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Since Eli Lilly and Company first launched duloxetine (brand name "Cymbalta") in August 2004, its sales revenue has been continually increasing, which nearly reached USD 5 billion in 2012.
The success of duloxetine sales also comes from its persistent exploration and study into indications. It is approved to treat adult depression by FDA and EU in August and September 2004 respectively. In September 2004 FDA approved its treatment for new important indications of diabetic peripheral neuropathic pain, making it the first drug approved for these diseases. In August 2004 duloxetine was also approved to cure women patients who lack effective treatment of moderate - severe stress urinary incontinence symptoms. Duloxetine was also authorized to treat fibromyalgia in June 2008 and chronic musculoskeletal pain in November 2010 by FDA. It is this constant innovation that makes duloxetine produced by Eli Lilly and Company best selling antidepressant worldwide. Before patent of duloxetine expired at the end of 2013, almost all famous general drug manufacturers planed to seize this great opportunity. In recent years, some pharmaceutical companies have earned provisional approvals issued by FDA.
Many manufacturers did not report the production of raw materials and preparation until 2005. However, only Shanghai Zhongxi Pharmaceutical Co., Ltd. successfully produced generic drug before duloxetine was under administrative protection, and was given the production approval of enteric-coated capsules and enteric-coated tablets. In present Chinese market, only Eli Lilly and Company and Shanghai Zhongxi Pharmaceutical Co., Ltd. are approved to sell duloxetine products. Yet in July 2013, some other manufacturers received drug registration approval of duloxetine APIs and enteric-coated tablet issued by FDA, whose products are expected to go on the market in 2014.
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