Today Natco confirmed the first to file status in press release and will have 180 days exclusivity if Natco ANDA approved by FDA. Natco ties up with Alvogen for marketing generic version in USA.
As of now, Gilead has not sued Natco yet and its has time to sue Natco (45 days time). Gilead announced the receipt of paragraph IV notice letter on Feb 07, 2011. Natco’s ANDA approval will be stayed till 30 months (date of submission is Nov 15, 2010), if Gilead sues within 45 days.
Three patents are listed in Orange Book which are 5763483; 5866601 & 5952375. As per Gilead announcement Natco challenged ‘483 patent which expires after other patents (‘601 & ‘375).
Gilead sued Natco on Monday, March 14, 2011 @ Delaware District Court (RFC express)