Whoomp! There It Is! The Other Shoe Hits the Floor as FDA Strips Ranbaxy of 180-Day Exclusivity for Generic NEXIUM

By Kurt R. Karst – 

Earlier today (January 26, 2015), FDA announced the first approval of an ANDA for a generic version of AstraZeneca Pharmaceuticals LP's (“AstraZeneca's”) NEXIUM (esomeprazole magnesium) Delayed-Release Capsules, 20 mg and 40 mg.  But it wasn’t Ranbaxy Laboratories, Ltd./Ranbaxy, Inc. (“Ranbaxy”) that scored the approval for its long-pending application (ANDA 077830); it was Teva Pharmaceuticals USA subsidiary Ivax Pharmaceuticals, Inc. that scored the approval of its application (ANDA 078003).  Generic NEXIUM is expected by some folks to be one of the most lucrative generic launches in years.

The fact that purported first-filer Ranbaxy was not the recipient of the ANDA approval could mean only one thing for the company: that FDA determined that Ranbaxy forfeited eligibility for 180-day exclusivity.  (FDA's approval of ANDA 078003 also appears to indicate that before approving the application, AstraZeneca waived successive and overlapping periods of pediatric exclusivity expiring on May 25, 2015 and August 3, 2015 and associated with U.S. Patent Nos. 5,690,960 and 5,714,504, respectively, that would otherwise have prevented ANDA approval until later this year.)  Indeed, in a Notice of Administrative Action filed in the U.S. District Court for the District of Columbia in pending litigation concerning the stripped tentative approvals for both generic NEXIUM and VALCYTE (valganciclovir) Tablets, 450 mg, FDA states:

Defendants . . . hereby withdraw their argument that Ranbaxy’s claims in this matter regarding generic esomeprazole are unripe and lack final agency action.

Today, FDA determined that Ranbaxy had forfeited its eligibility for 180-day exclusivity for esomeprazole because it failed to obtain tentative approval of its ANDA within 30 months after the date on which the ANDA was submitted and that failure was not caused by a change in or a review of the requirements for approval, and notified Ranbaxy of this determination.

The failure-to-obtain-timely-tentative approval basis for generic NEXIUM is the same basis FDA used to determine that Ranbaxy forfeited eligilbity for 180-day exclusivity for generic VALCYTE (see our previous post here), and that led Ranbaxy to sue FDA over the decision and the stripped tentative approvals (see our previous post here).  Both Dr. Reddy’s (represented by Hyman, Phelps & McNamara, P.C.) and Endo intervened in the case.  A merits decision in the case has been pending since Judge Beryl A. Howell issued a Minute Order earlier this month vacating a hearing scheduled for January 9, 2015.  Late on January 26th, Ranbaxy filed a Motion for Expedited Ruling on Pending Motions.

FDA also states in the court filing that the Agency responded to and denied a 2012 Citizen Petition (Docket No. FDA-2012-P-0661) related to generic esomeprazole.  In that petition, Sandoz Inc. (“Sandoz”) asked FDA to determine whether Ranbaxy forfeited 180-day exclusivity eligibility for generic NEXIUM as a result of FDA’s February 5, 2008 tentative approval of the application (which was later stripped).  The ANDA was received as of August 5, 2005, so February 5, 2008 was the 30-month anniversary date of submission.  Although FDA has previously indicated through at least one approval precedent (see our previous post here) that a tentative approval on the 30-month anniversary date is timely tentative approval for 180-day exclusivity forfeiture purposes, FDA’s denial of the Sandoz petition appears to be the first instance in which the Agency has publicly described its rationale.