FDA Appeals Decision on Generic Zocor to D.C. Circuit
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 Merck's patents on Zocor in the Orange Book. The FDA denied the petitions, and so Ranbaxy and Teva sued the FDA in federal court. The parties have agreed to an expedited appeal schedule.
In addition, Teva announced that it has received tentative approval from the FDA for its generic Zocor products. Merck's final patent on Zocor is set to expire on June 23, 2006, and analysts expect Teva and Ranbaxy to launch generic Zocor on or shortly after that date. Teva would have generic exclusivity on four dosage strengths, while Ranbaxy would have exclusivity on a fifth dosage strength. Zocor is the world's second-biggest selling drug (behind Pfizer's Lipitor), with $4.6 billion in annual sales.
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