FDA Resolves 180-Day Exclusivity Forfeiture for Tentative Approvals that Occur on the 30-Month ANDA Submission Anniversary Date

By Kurt R. Karst –

FDA’s recent approval of Caraco Pharmaceutical Laboratories, Ltd.’s (“Caraco’s”) ANDA No. 077571 for a generic version of PRANDIN (repaglinide) Tablets is interesting on several fronts.  For starters, it is the ANDA at the heart of the U.S. Supreme Court’s decision in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, in which the Court held that a patent use code  qualifies as “patent information” submitted under FDC Act §§ 505(b) and (c) and may be the subject of a counterclaim to correct or delete patent information.  But the Caraco approval also marks FDA's resolution of an important exclusivity issue: whether 180-day exclusivity may be granted for an ANDA tentatively approved on the date that is the 30-month submission anniversary date.

As we previously reported, in June 2012, Sandoz Inc. (“Sandoz”) submitted a citizen petition to FDA (Docket No. FDA-2012-P-0661) seeking the Agency’s determination as to whether purported first applicant Ranbaxy, the sponsor of ANDA No. 077830 for a generic version of NEXIUM (esomeprazole magnesium) Delayed-release Capsules, 20 mg and 40 mg, forfeited 180-day exclusivity eligibility in connection with its ANDA as a result of FDA’s February 5, 2008 tentative approval of the application.  The ANDA was received as of August 5, 2005, so February 5, 2008 was the 30-month anniversary date of submission. 

Under FDC Act § 505(j)(5)(D)(i)(IV), 180-day exclusivity eligibility is forfeited if:

The first applicant fails to obtain tentative approval of the application within 30 months after the date on which the application is filed, unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is filed. [(Emphasis added)]

The 2012 FDA Safety and Innovation Act (“FDASIA”) made changes with respect to the application of FDC Act § 505(j)(5)(D)(i)(IV) to certain ANDAs.  In particular, for ANDAs submitted to FDA between January 9, 2010 and July 9, 2012 initially containing a Paragraph IV certification to a patent listed in the Orange Book for the Reference Listed Drug (“RLD”), or that are amended between January 9, 2010 and July 9, 2012 to first contain a Paragraph IV certification to a patent listed in the Orange Book for the RLD, the time to obtain timely tentative approval (or final approval if tentative approval is not warranted) is 40 months during the period of July 9, 2012 and September 30, 2015, and not 30 months.  

According to the Sandoz Citizen Petition:

Based on the apparent date on which Ranbaxy’s ANDA was submitted to FDA and the date on which it received tentative approval, Ranbaxy has forfeited its 180-day exclusivity under forfeiture condition (IV), failure to receive tentative approval “within” 30 months after ANDA submission, because Ranbaxy did not obtain tentative approval until the first day of the 31st month and thus not “within” 30 months. (Emphasis in original)

The same argument would apply post-FDASIA, where an affected ANDA is tentatively approved on the 40-month anniversary date.

The earliest expiring patents listed in the Orange Book for NEXIUM Delayed-release Capsules don’t expire until 2014, so it seems unlikely that FDA will substantively respond to the Sandoz petition before then.  But, in reality, FDA has already offered a response . . . . in the form of the Agency’s approval letter for Caraco’s repaglinide ANDA No. 077571 granting 180-day exclusivity.  Moreover, the Sandoz Citizen Petition identifies the then-pending 180-day exclusivity decision on Repaglinide Tablets in a footnote as another instance in which the petition applies “with equal force to the same factual scenario.”  And, back in 2010, Caraco issued a quarterly report stating with respect to 180-day exclusivity for Repaglinide Tablets that:

On May 26th, 2010, the Company received correspondence from the FDA forwarding a letter sent by Sandoz Inc. to the FDA challenging the Company’s 180 day exclusivity based on when the Company received tentative approval for its product.  The Company responded to the FDA on June 17, 2010.  On June 28th, 2010, Sandoz Inc. replied to the Company’s correspondence.  The Company issued a further letter to the FDA stating its position regarding the 180 day exclusivity on July 9, 2010.  The Company believes it received tentative approval timely, and that it has the potential to obtain 180 day exclusivity for this product.  It intends to defend that position vigorously.

FDA has, in the past, issued private letter decisions explaining the Agency’s position and interpretation of the law when confronted with exclusivity disputes raised in private correspondence.  We suspect that is the case here; however, until any decision is made public, most folks will not have clarity on FDA’s rationale for determining that exclusivity eligibility is not forfeited for 30-month anniversary tentative approvals.  But we have an inkling that FDA explains its historical and current counting methodology based on the statutory text, and how that squares with other statutory deadlines and the tentative approval forfeiture provision. 

In any case, FDA’s exclusivity decision, as reflected in the Caraco approval letter, appears to represent the Agency’s final decision on the “within 30/40 months” matter.  As such, the approval might provide a basis for an ANDA sponsor that believes it will be aggrieved by the decision, as applied to a different drug product, to take further action.