Earlier in November, 2019, through a letter to Taiho,the Indian drug makernotified that it submitted ANDA (abbreviated new drug application) to the US FDA seeking approval to engage in commercial manufacture and sell the generic version in America prior to the expiration of the patents-in-suit, the petition said.
Taiho further alleged that Natco's proposed ANDA violates the Lonsuf's patents on six counts.
Under Paragraph IVPatentCertifications, a company can seek FDA approval to market a generic drug before the expiration ofpatentsrelated to the brand-name drug that the generic seeks to copy.
A senior official of a city-based pharmaceutical company saidpatent infringement cases in the US are not uncommon for generic drug makers and the lawsuit will not have any implications on the performance of the copycat makers.
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