Amarin Corp Plc (AMRN)

[Hike]

Codify Our Active Moiety Approach for New Chemical Entity (NCE) Determinations

The Agency’s regulation implementing the statutory provisions on 5-year New Chemical Entity
(NCE) exclusivity focuses on evaluating a drug’s active moiety. Under this regulation,
eligibility for NCE exclusivity is available only for a drug containing no active moiety that has
been previously approved by FDA. This approach ensures that only the most innovative drugs
qualify for NCE exclusivity, while allowing for earlier generic competition for drugs that do not
qualify. A recent district court decision (Amarin Pharmaceuticals Ireland Ltd. v. FDA)
invalidated an FDA NCE exclusivity decision that applied FDA’s active moiety regulation based
on the court’s interpretation of the statute’s “plain meaning.” This decision has resulted in
uncertainty about FDA’s ability to continue to apply its regulation. This proposal would codify
FDA’s long-standing “active moiety” approach, and would provide clarity about Congress’
intent that only the most innovative new drugs qualify for NCE exclusivity.