Natco Gilead Tamiflu ANDA

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).

Update: 16/03/2011

Gilead sued Natco on Monday, March 14, 2011 @ Delaware District Court (RFC express)

About Guna

Interested to learn things around me
This entry was posted in Patent case and tagged , , , . Bookmark the permalink.

1 Response to Natco Gilead Tamiflu ANDA

  1. Pingback: RoboPutt siap melatih anda bermain golf :: Great Golf Swing Tips

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s