It was revealed today that Mylan has filed suit at the Washington District Court in an effort to get the FDA to withdraw Ranbaxy’s first-to-file (FTF) status for its generic version of Pfizer’s blockbuster anti-cholesterol drug, Lipitor (atorvastatin), and hence to rescind Ranbaxy’s 180 days of market exclusivity. Mylan’s argument appears to be that because the FDA closed down Ranbaxy’s Paonta Sahib facility, where its generic version of atorvastatin was developed, the data used in the filing can’t be considered to be reliable. Specifically, Mylan wants to force the FDA to say whether Ranbaxy’s marketing application ‘is tainted by Ranbaxy’s misconduct’ with the implication being that if it is, Ranbaxy should not get final approval for its product and nor should it be eligible for six months of market exclusivity.
In our view, this is an interesting line of attack by Mylan (which would be a big beneficiary if Ranbaxy loses its exclusivity), but is very unlikely to be successful. To be eligible for FTF status, a company only has to file a ‘substantially complete’ ANDA, not an approvable one. Nor is there any requirement for the production site to have been inspected by the FDA as part of the filing process, this happens at the approval stage. There are also plenty of examples of companies retaining their 180 days of exclusivity despite having had the product’s production site closed down by the FDA – Teva’s recent launch of gemcitabine via a tie-up with APP is a case in point. Of course, it was never suggested that Teva had actually falsified data at its Irvine facility, whereas the FDA has previously stated that it believes Ranbaxy to have done exactly that at Paonta Sahib, but it is surely up to the FDA to determine what constitutes a ‘substantially complete’ ANDA and then to request additional data (such as repeated versions of any tests that it has doubts about) as it sees fit.
Were Mylan to prevail in court, it would obviously be very bad news for Ranbaxy, which is expecting to achieve sales in the region of $0.5bn in its exclusivity period. However, it would also be bad for Watson, which has an agreement with Pfizer allowing it to launch a generic on 30th November, the same day that Ranbaxy should get to market. In the event that Ranbaxy doesn’t get approval but retains its 180 days of exclusivity, Watson could be alone on the market for some time, although the financial benefit of this would be limited by its agreement with the shareholders of Arrow Pharmaceuticals, who struck the deal with Pfizer and will take most of the profits accruing from it. On the other hand, if there are multiple market entrants in November, Watson would do far less well than it currently hopes on atorvastatin, so it will certainly be hoping that Mylan’s suit doesn’t succeed.
Posted on 21st March 2011