On July 13, 2018, the FDA issued a letter to ANDA applicants for buprenorphine and naloxone sublingual film that has application beyond that drug product because it clarified two important aspects for determining 180-day exclusivity. The premise of the 180-day exclusivity under the Hatch-Waxman Act is that the “First Applicant” to challenge a drug patent is entitled to 180 days of exclusivity against subsequent generic applicants. However, the statute defines certain events that will result in a forfeiture of the 180-day exclusivity, one of which is the First Applicant’s failure to market its generic product within the time frame set by the statute. The FDA’s July 13, 2018, letter clarified who qualifies as a First Applicant and when the failure to market forfeiture is triggered.

Section 505(j)(5)(B)(iv)(bb) of the Federal Food Drug & Cosmetic Act (FDCA) defines a First Applicant as an applicant that:

[1] on the first day on which a substantially complete application containing a [paragraph IV certification] is submitted for approval of a drug, [2] submits a substantially complete application that contains [a paragraph IV certification] and [3] lawfully maintains a [paragraph IV certification] for the drug.

The law prior to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) provided a different statutory definition of First Applicant. Under the pre-MMA statute, the FDA had applied a “First Effective” test for determining who was a First Applicant. Under that test, an applicant was a First Applicant if it (1) had submitted a substantially complete ANDA with a paragraph IV certification, and (2) had provided timely notice of its ANDA filing to the brand company.

In its July 13, 2018, letter, the FDA explained that it would not use the First Effective test for determining the First Applicant under the MMA because doing so would be inconsistent with the first prong of the MMA’s definition of First Applicant. Instead, the FDA determined that for ANDAs filed under the MMA, there would be a single criteria for determining if an applicant qualified as a First Applicant, namely, a First Applicant is an applicant who has submitted a substantially complete ANDA with a paragraph IV certification. There is no longer a requirement that to qualify as a First Applicant the applicant must have provided timely notice of its ANDA filing to the brand. From a practical perspective, elimination of the notice requirement provides greater certainty and predictability as to who will qualify as the First Applicant. However, it is important to note that a First Applicant must still provide timely notice to the brand to qualify for the 180-day exclusivity.

A second issue addressed in the FDA’s July 13, 2018, letter concerned when another applicant can trigger the marketing forfeiture provision under Section 505(j)(5)(D)(i)(I), which provides that the 180-day exclusivity will be forfeited if the “first applicant fails to market the drug by the later of (aa) the earlier of the date that is – (AA) 75 days after the date on which the approval of the application of the first applicant is made effective under subparagraph (B)(iii); or (BB) 30 months after the date of submission of the application of the first applicant; or (bb) with respect to the first applicant or any other applicant (which other applicant has received tentative approval), the date that is 75 days after the date as of which, as to each of the patents with respect to which the first applicant submitted and lawfully maintained a certification qualifying the first applicant for the 180-day exclusivity period under subparagraph (B)(iv), at least 1 of the following has occurred …”1 (emphasis added).

Specifically, the FDA addressed whether (bb) is only implicated when tentative approval by another ANDA applicant occurs prior to a subparagraph (bb) marketing forfeiture event. The FDA answered no, stating that the other applicant’s tentative approval can occur at any time prior to or after the subparagraph (bb) event occurs, as long as the tentative approval occurs by the time the FDA makes the forfeiture determination. The effect of the FDA’s interpretation is an expansion of the circumstances under which another applicant may trigger a forfeiture of the First Applicant’s 180-day exclusivity.