Natco Pharma has filed a Para IV for Tamiflu generic. The company has an exclusive first-to-file opportunity on it. Tamiflu, a USD 500 million market in the US and over USD 1 billion in global sales is invented by Gilead. Gilead has 45 days to challenge the patent.
Natco has tied up with Luxembourg-based pharmaceutical firm Alvogen for marketing and sale of the generic. In an interview with CNBC-TV18, Bhaskar Narayana, Finance Director & CFO, Natco Pharma gave his perspective on the tie-up with Alvogen and the first-to-file opportunity for Tamiflu. Below is a verbatim transcript. Also watch the accompanying video. Q: Can you take us through what this opportunity for you is for Tamiflu generic. I understand you are an FTF on it, could you confirm that for us and two have you already received US FDA approval from this who is an at-risk launch a possibility at all? A: The company has filed an abbreviated new drug application (ANDA) that has been accepted by the US FDA. The FDA has confirmed that Natco is the first applicant to have filed an ANDA for the generic version of Tamiflu which essentially means that after the expiry of the patent, the company would be entitled for 180 days exclusive marketing opportunity after the expiry of the patent. Now Tamiflu is a drug which has clocked a little over USD 1 billion in sales last year and we have partnered with a Luxembourg based company called Alvogen to distribute the product in the US. Q: I couldnDiscover the latest Business News, Sensex, and Nifty updates. Obtain Personal Finance insights, tax queries, and expert opinions on Moneycontrol or download the Moneycontrol App to stay updated!
