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USFDA Gives Green Light to Sale
Korea's Improved Version of Nexium
USFDA Gives Green Light to Sale
  • By matthew
  • August 8, 2013, 06:35
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According to the Ministry of Health and Welfare on August 7, a Korean stomach drug has won approval from the Food and Drug Administration of the United States for sale in the country, which allows the Korean pharmaceutical company access to a market worth US$6 billion annually. 

The drug developed by Hanmi Pharmaceutical Co., one of the major South Korean drugmakers, is an improved version of Nexium of AstraZeneca that treats symptoms of gastroesophageal reflux disease.

Hanmi plans to release the drug, Esomeprazole Strontium, in the U.S. soon through its U.S. marketing partner Amneal Pharmaceuticals.

The approval came two months after Hanmi Pharmaceutical ended two years of patent litigation with AstraZeneca, a British biopharmaceutical company over Esomeprazole Strontium. In June, the two reached a legal settlement that two of AstraZeneca's patents are valid, but it said that Hanmi's product didn't violate the patents, according to FiercePharma, a daily monitor of the pharmaceutical industry.

FiercePharma said on its website in June, "AstraZeneca will appeal the finding, but if Hanmi gets FDA approval while the appeal is pending, it can launch its drug at-risk. That would mean if AstraZeneca wins its appeal, Hanmi would face double damages."

Hanmi Pharmaceutical spokesman Park Chan-ha said he had no immediate comment on the reported possible damages, citing a confidential deal with AstraZeneca.

Sales of Nexium reached $6 billion in the US in 2012 alone, making it the no. 1 prescription drug in the world's largest economy.