FDA Explains How It Counts To 30 Months

Agency rejects Sandoz’s assertion that the 30-month period for securing ANDA tentative approval under the MMA’s forfeiture provisions begins to run on the date an application is submitted.

The 30-month period during which an ANDA first-filer must obtain tentative approval or face forfeiture of its rights to 180-day marketing exclusivity begins to run on the day after the application is filed, FDA said in a Jan. 26 citizen petition response.

In a June 2012 petition, Sandoz Inc. challenged Ranbaxy Laboratories Ltd.’s eligibility for generic marketing exclusivity on AstraZeneca PLC’s proton pump inhibitor Nexium (esomeprazole) based upon its view of how the 30-month period for securing tentative approval should be calculated.

FDA responded to the Sandoz petition on the same day it approved Teva Pharmaceutical Industries Ltd.’s esomeprazole ANDA and declared that Ranbaxy had forfeited its rights to marketing exclusivity because it failed to obtain tentative approval within the 30-month time limit, although for reasons different than those asserted by Sandoz (see related story, (Also see "Nexium Generics: Ranbaxy’s Exclusivity Loss Is Teva’s Gain" - Pink Sheet, 2 Feb, 2015.)).

Focusing On The Term ‘Within’

FDA received Ranbaxy’s ANDA on Aug. 5, 2005. This was the first application filed for esomeprazole that contained a paragraph IV certification, thereby making Ranbaxy eligible for 180-day marketing exclusivity. FDA tentatively approved the Ranbaxy ANDA on Feb. 5, 2008.

In the Medicare Modernization Act of 2003, Congress established various conditions under which an ANDA first-filer can forfeit its eligibility for 180-day marketing exclusivity. One of these conditions is the first applicant’s failure to obtain ANDA tentative approval “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 requirements for approval.”

Sandoz’s petition focused on the statute’s use of the word “within” in the 30-month forfeiture provision. The company argued that the language should be interpreted as requiring that an applicant must obtain tentative approval at least one day prior to the day that is 30 months from the day on which the application is filed.

“In presenting this position, the petition argues that FDA should calculate the 30-month period starting on (and thus including) the date the ANDA is filed, rather than beginning on the day after the date on which the application is filed,” FDA said. “The petition argues that February 4, 2008, was the last day ‘within’ the 30-month period, and thus Ranbaxy should forfeit its eligibility because the company obtained tentative approval on February 5, 2008.”

Petition Is Both Moot And Flawed

As a threshold matter, the agency points out that it rescinded Ranbaxy’s tentative approval for esomeprazole on Nov. 4, 2014 after determining that it had been granted in error (Also see "Ranbaxy Exclusivity Implosion Pushes Valcyte Generics Towards Launch; Nexium Remains ‘Very Hazy’" - Pink Sheet, 6 Nov, 2014.).

“Your petition therefore is moot to the extent that it depends upon the fact that FDA tentatively approved Ranbaxy’s ANDA on February 5, 2008,” the agency said. “In any event, FDA concludes that the petition’s presumption that the 30-month period should begin on the day the ANDA is filed is flawed.”

Under the statute’s plain language, the 30-month period begins to run the day after the ANDA is filed, not the date of filing. “Thus, the last day of the 30-month period lands on the 30-month ‘anniversary date,’” FDA said.

“To interpret ‘after the date’ to include the day of the trigger event – here the date of filing – effectively would read the word ‘after’ out of the statute,” FDA said. “Courts that have considered analogous ‘after’ language in the Hatch-Waxman context similarly have concluded that the relevant period begins the day after the trigger event.”

The agency rejected Sandoz’s attempt to draw comparisons between the generic drug forfeiture provision and the exclusivity provisions for new chemical entities.

An ANDA referencing a new chemical entity may not be submitted before expiration of five years from the date of NDA approval, although an ANDA may be submitted after four years if it contains a paragraph IV certification. FDA calculates the five-year NCE period beginning on the day of NDA approval.

“Reference to the NCE exclusivity provision is not an appropriate comparator … because it differs from the 30-month forfeiture provision in a critical aspect,” the agency said.

“Under the plain language of this provision, the trigger date should be included in determining the NCE exclusivity period; ‘from’ includes the date it references,” FDA said. “This contrasts directly with ‘after the date’ used in the 30-month forfeiture provision to describe the start of the period in which tentative approval must be obtained.”

FDA said it has consistently interpreted the 30-month period to begin on the day after a substantially complete ANDA with a paragraph IV certification was filed with the agency. Furthermore, the agency has “tentatively approved or approved numerous ANDAs on the 30-month ‘anniversary date’ of ANDA receipt for which the sponsor was granted 180-day exclusivity.”

In an FDA Law Blog post, Hyman Phelps & McNamara director Kurt Karst said that although the agency has previously indicated that a tentative approval on the 30-month anniversary date is timely for purposes of the forfeiture provisions, “FDA’s denial of the Sandoz petition appears to be the first instance in which the agency has publicly described its rationale.”