A Costly 180: The D.C. Circuit Flips FDA’s Forfeiture Playbook🔒 SSL Verified

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"What a year for Hatch-Waxman litigation!  With the Supreme Court’s decision in Amarin v. Hikma, it’s already been a big year for the Hatch-Waxman Amendments, but now we have another case from the D.C. Circuit that touches on an important aspect of generic drug incentives: 180-day exclusivity.  More specifically, 180-day exclusivity forfeiture, a topic so complicated that FDA’s Guidance on 180-Day Exclusivity spends 12 of its 26 pages of Frequently Asked Questions explaining it."

"There are six different ways to forfeit exclusivity under the Hatch-Waxman Amendments, and today’s case deals with two of them: “failure to market” and “failure to obtain tentative approval” (at FDC Act § 505(j)(5)(D)(i)(I) and § 505(j)(5)(D)(i)(IV), respectively)   Under the “failure to market” provision, the Federal Food, Drug, and Cosmetic Act states that 180-day exclusivity eligibility is forfeited by the “later of” date of the two bookend dates described at FDC Act § 505(j)(5)(D)(i)(I)(aa) and (bb).  The first bookend date under item (aa) is 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."

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