Teva And Ranbaxy Launch Generic Zocor With 180-Day Exclusivity
This article was originally published in The Pink Sheet Daily
Executive Summary
Despite an eleventh-hour suit by Sandoz, FDA approved the generic companies’ ANDAs for simvastatin.
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Teva and Ranbaxy launched generic Zocor following a Washington, D.C. federal court order denying Sandoz' eleventh-hour request for a temporary restraining order June 23. FDA granted final approval June 23 to Teva's 5 mg, 10 mg, 20 mg, and 40 mg and Ranbaxy's 80 mg versions of simvastatin. Both firms have 180-day exclusivity. Also, Dr. Reddy's launched an authorized generic of the statin the same day under an agreement reached with Zocor manufacturer Merck in January. Novartis subsidiary Sandoz filed a complaint against FDA June 22 challenging "FDA's decision not to grant final approval to the abbreviated new drug applications of Sandoz and other similarly situated sponsors for generic versions of Zocor." The complaint sought to delay the approval of Teva's and Ranbaxy's ANDAs until FDA issued final approval for all ANDA filers who did not certify to two patents covering Zocor that were de-listed from FDA's "Orange Book." Teva and Ranbaxy had filed the first ANDAs with Paragraph IV certification against those patents. A D.C. federal court decided May 1 that the agency had improperly applied standards for de-listing the two Zocor patents and reinstated Teva's and Ranbaxy's exclusivity periods (1 (Also see "Statin Prices Likely To Remain High After Zocor Exclusivity Win" - Pink Sheet, 1 May, 2006.)). FDA has appealed the court's decision; the agency told "The Pink Sheet" DAILY that it has agreed to comply with the order in the interim. The Washington, D.C. federal appeals court has scheduled the oral arguments to commence Sept. 12. According to Teva, annual sales of Zocor for the 5 mg, 10 mg, 20 mg, and 40 mg strengths totaled approximately $4.1 bil. for the period ending March 2006. -Kathryn Phelps |