One Down, One to Go: FDA Strips Ranbaxy of 180-Day Exclusivity for Generic VALCYTE; Is Generic NEXIUM Next?

November 6, 2014

By Kurt R. Karst –      

We learned this week that FDA finally approved ANDAs for generic versions of Hoffmann-LaRoche, Inc.’s VALCYTE (valganciclovir) Tablets, 450 mg (NDA 021304).  We don’t usually post on FDA’s daily ANDA approval activities, but the valganciclovir ANDA approvals are of special significance. . . . and might foreshadow another FDA action on a long-awaited generic version of AstraZeneca LP’s NEXIUM (esomeprazole magnesium) Delayed-Release Capsules, 20 mg and 40 mg (NDA 021153).

Ranbaxy Laboratories, which entered into a Consent Decree with FDA and the Department of Justice in January 2012, was believed to be the first applicant eligible for 180-day exclusivity for generic VALCYTE.  Indeed, the company acknowledged this in a 2008 press release after FDA tentatively approved the company’s ANDA, stating “Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, thereby providing a potential of 180-days of marketing exclusivity, offering a significant opportunity in the future.”  (Interestingly, that tentative approval was recently removed from FDA’s website.)  But it appears almost certain that the company’s data integrity and manufacturing problems prevented FDA from granting final ANDA approval. 

Meanwhile, generic competition was stalled because of Ranbaxy’s eligibility for 180-day exclusivity.  Frustration mounted by many people seeking generic competition, and earlier this year, our firm submitted a Citizen Petition to FDA requesting that the Agency take action to remove Ranbaxy’s block on competition for generic VALCYTE, as well as for generic NEXIUM and DIOVAN (valsartan) Tablets (see our previous posts here and here).  (FDA later approved Ohm Laboratories Inc.’s [Ranbaxy’s] ANDA 077492 for generic DIOVAN and granted 180-day exclusivity.)

According to FDA’s ANDA approvals for generic VALCYTE:

The Agency determined today that the applicant who was first to file a substantially complete ANDA with a paragraph IV certification to the remaining patent listed for the reference listed drug (RLD) has forfeited its eligibility for 180-day generic drug exclusivity under section 505(j)(5)(B)(iv) of the act.

Our presumption was that FDA stripped Ranbaxy of 180-day exclusivity eligibility under the terms of the Consent Decree, which states in relevant part:

If Corporate Defendants have not completed their substantial completeness submissions pursuant to paragraph XIV.A, audit plans pursuant to paragraph XIV.B.1, and audits pursuant to paragraph XIV.B.2, for each of the following Excepted Applications by the following dates, Corporate Defendants shall, upon written notification from FDA, be deemed to have relinquished any claim to 180-day exclusivity for such Excepted Application(s) and shall not interpose any objection in any forum to FDA’s approval of any other ANDAs held by other sponsors for the drugs subject to such Excepted Application(s) after such date: ANDA 1, by December 31, 2012; ANDA 2, by January 31, 2013; ANDA 5, by July 31, 2013; and ANDA 4, by September 30, 2014.

But according to a press report, FDA informed Ranbaxy that the Agency’s tentative approval decision was “in error because of the compliance status of the facilities.”  “The FDA also told the Indian drugmaker there were no ‘data integrity’ issues related to the company's filings for the two drugs,” continues the report.  In other words, Ranbaxy forfeited eligibility for exclusivity under FDC Act § 505(j)(5)(D)(i)(IV) for failure to obtain timely tentative approval within 30 months of ANDA submission.  (In the case of generic DIOVAN, where FDA granted 180-day exclusivity, any failure to have obtained timely tentative approval was excepted – see here.)

FDA’s action on Ranbaxy’s ANDA for generic VALCYTE necessarily raises the question as to whether or not the Agency is poised to take a similar action with respect to Ranbaxy’s ANDA for generic NEXIUM.  When FDA tentatively approved the company’s ANDA in 2008, Ranbaxy commented in a press release that it “believes that it has a FTF (First to File) status on the drug, providing it with a potential 180 days marketing exclusivity, thereby offering a significant opportunity in the future.” 

Although recent press reports (see here) say that Ranbaxy continues to believe it has 180-day exclusivity, FDA’s action on generic VALCYTE calls that belief into question.  Moreover, we note that FDA recently removed from its Drugs@FDA website any mention of the company’s tentative ANDA approval for generic NEXIUM, just as with generic VALCYTE.