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Natco Pharma Ltd has filed an abbreviated new drug application (ANDA) for Sofosbuvir tablets with the United States Food and Drug Administration (USFDA), according to a company release issued here on Thursday.
The Hyderabad-based company said: “They are the first to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity upon receiving final FDA approval.”
Sofosbuvir is used for chronic hepatitis C infection and sold globally by Gilead Sciences, Inc, under its brand Sovaldi.
For the 12 months ending December 31, 2017, Sovaldi had US sales of approximately $130 million as per Gilead Sciences Inc’s unaudited results released for the year ending December 31, 2017, Natco Pharma said.
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