AstraZeneca recently filed a Request for Advisory Opinion with the FDA, asking for a determination "whether patents on drug delivery systems, such as inhalation devices, that do not recite the approved active ingredient or formation," should be listed in the Orange Book.  GlaxoSmithKline submitted a request to the FDA in January, 2005, asking the very…

The FDA recently published a letter to attorneys representing generic drug companies who filed citizen petitions relating to their ANDAs for generic Zocor. The three-page letter essentially ties up some loose ends that remained after the District of Columbia’s April 30, 2006 decision holding that it was unlawful for the FDA to deny IVAX and…

The District Court for the District of Columbia today denied Sandoz’s motion for a preliminary injunction, filed June 22, 2006, to delay final FDA approval of Teva and Ranbaxy’s generic versions of Zocor.  Previously, the same court denied Sandoz’s request for a temporary restraining order.  The FDA granted final approval to Teva and Ranbaxy on…

The FDA today granted final approval to Ivax and Ranbaxy to market generic versions of Zocor (simvastatin).  Additionally, it appears the FDA has granted generic marketing exclusivity to Ivax and Ranbaxy for the next 180 days. The FDA approval comes despite a last-ditch effort by Novartis subsidiary Sandoz to prevent the FDA from granting final…

Bloomberg News is reporting tonight that Sandoz, the generics arm of Novartis AG, filed a request for a temporary restraining order today in an attempt to prevent the FDA from granting Ivax and Ranbaxy final approval tomorrow to market generic Zocor (simvastatin). The motivation behind Sandoz’s eleventh hour request is not entirely clear, especially because…

The FDA has appealed the decision in Ranbaxy v. Leavitt to the D.C. Circuit Court of Appeals.  On May 1st, the district court in the case found that by denying Ranbaxy’s and Teva’s citizen petitions, the FDA improperly stripped the companies of their 180-day marketing exclusivity rights for generic Zocor.  The citizen petitions had asked the FDA to relist…

In a recent decision, Ranbaxy v. Leavitt, the federal district court for the District of Columbia held that the FDA improperly denied Ivax’s (a division of Teva) and Ranbaxy’s citizen petitions to relist two Merck patents on Zocor.  According to the court, by denying the citizen petitions, the FDA effectively nullified Ivax’s and Ranbaxy’s rights…