Amarin Corp Plc (AMRN)

[HDGabor]

g-

That's my take in this case.

Q18. Does 180-day exclusivity block approval of all ANDAs that reference the same RLD?

No. 180-day exclusivity blocks only the approval of subsequent ANDAs that also contain a paragraph IV certification. There are several examples in which 180-day exclusivity does not block approval of another ANDA referencing the same RLD:

• If an ANDA was approved before the NDA holder submitted a patent that provides the basis for first applicant status for a pending ANDA, any related 180-day exclusivity would not affect the previously approved ANDA.

• If an ANDA applicant seeks to omit the approved method(s) of use covered by a listed patent with a section viii statement, another ANDA applicant’s paragraph IV certification to that same patent, and any related 180-day exclusivity, would not block approval of the ANDA that contained the section viii statement.

• If a patent was late-listed vis-à-vis a pending ANDA under FDA’s regulations, a first applicant’s paragraph IV certification to that patent, and any related 180-day exclusivity, would not block approval of the ANDA for which the patent is late-listed and for which
as a result no patent certification was required.

Guidance for Industry, 180-Day Exclusivity: Questions and Answers

Best,
G