Ranbaxy Sues FDA Over Stripped Tentative Approvals for Generic VALCYTE and NEXIUM and Lost Exclusivity

By Kurt R. Karst –      

Last Friday, Ranbaxy Laboratories, Ltd. and Ranbaxy, Inc. (“Ranbaxy”) filed a Complaint and a Motion for a Temporary Restraining Order and Expedited Preliminary Injunction in the U.S. District Court for the District of Columbia challenging FDA’s November 4, 2014 Letter Decision stripping Ranbaxy of tentative approvals for the company’s ANDAs for generic versions of VALCYTE (valganciclovir) Tablets, 450 mg (Ranbaxy ANDA 078078), and NEXIUM (esomeprazole magnesium) Delayed-Release Capsules, 20 mg and 40 mg (Ranbaxy ANDA 077830).  In that same decision, FDA ruled that Ranbaxy forfeited eligibility for 180-day exclusivity for Valganciclovir Tablets pursuant to FDC Act § 505(j)(5)(D)(i)(IV) because Ranbaxy failed to obtain timely tentative approval within 30 months of ANDA submission.  As we previously reported, FDA approved two ANDAs for generic VALCYTE – one from Dr. Reddy’s Laboratories (ANDA 203511), and another from Endo Pharmaceuticals (ANDA 200790) – after stripping Ranbaxy of its tentative approval and cxclusivity eligibility.

FDA states in the November 4, 2014 Letter Decision that the Agency rescinded the tentative ANDA approvals because of the compliance status of the facilities identified in the ANDAs.  Specifically, FDA states:

At the time of FDA’s February 5, 2008 [tentative approval] letter [for Esomeprazole Magnesium Delayed-release Capsules, 20 mg and 40 mg], the Paonta Sahib facility had been the subject of a Warning Letter issued on June 15, 2006, based on the CGMP violations observed during FDA’s February 20-25, 2006 inspection at the Paonta Sahib facility and taking into account Ranbaxy’s March 20, April 20, and May 25, 2006 responses.  Accordingly, at the time of the tentative approval letter, the compliance status of the Paonta Sahib facility was Official Action Indicated (OAI), which is an inspection conclusion reflecting that “objectionable conditions were found and a regulatory action is recommended.”  Under such circumstances, Center for Drug Evaluation and Research Office of Compliance (CDER Compliance) will not recommend approval.  The overall compliance status for ANDA 077830 was “withhold,” and the ANDA should not have been tentatively approved at that time due to the inspectional status. . . .

At the time of FDA’s June 20, 2008 [tentative approval] letter [for Valganciclovir Hydrochloride Tablets USP, 450 mg], the Dewas facility had been the subject of a January 28 – February 12, 2008 inspection that found significant deviations from CGMP in the manufacture of sterile and non-sterile finished products and in the manufacture and control of APIs, and that resulted in the issuance of a Warning Letter on September 16, 2008.  The Paonta Sahib facility had been the subject of the Warning Letter issued on June 15, 2006, and the Paonta Sahib Batamandi (Unit II) facility had been the subject of a March 3-7, 2008 inspection that found many significant deviations from CGMP in the manufacture of finished drug products, and that resulted in the issuance of a Warning Letter on September 16, 2008.  Accordingly, at the time of the tentative approval letter, the compliance status of the Dewas facility was “potential” OAI and the status of the Paonta Sahib facility was “OAI” and the ANDA should not have been tentatively approved at that time due to the inspectional status.

Ranbaxy alleges in its court filings that “FDA has no power to correct an alleged ‘mistake’ it made six years ago,” that “FDA’s Letter Decision conflicts with the plain language of the statute’s failure-to-obtain TA forfeiture trigger, which merely requires the first-filer to receive a TA letter from the Agency within the 30-month deadline,” and that “FDA’s Letter Decision cannot be squared with the plain text and structure of the statutory provisions that set forth the exclusive requirements for obtaining TA, on one hand, and final approval, on the other.”

A hearing on Ranbaxy’s Motion for a Temporary Restraining Order is scheduled for November 19th at 2:00 PM.  Both Dr. Reddy’s (represented by Hyman, Phelps & McNamara, P.C.) and Endo have intervened in the case.