Replies to post #262289 on Amarin Corp Plc (AMRN)

[JDUR]

Also:

"Defendants filed ANDAs including Paragraph IV Certifications based on Plaintiffs’
drug Vascepa. (See, e.g., ECF No. 1 at 1-6.) ANDAs must include the proposed labelling
that will accompany the generic drug—and that labelling must generally be substantially
the same as the labelling that accompanies the brand-name drug. See AstraZeneca, 633
F.3d at 1045-46. Here, Defendants’ proposed labelling is materially indistinguishable from
Plaintiffs’ labelling. (ECF Nos. 252 at 15, 245 (sealed).) Defendants also did not seek to
omit anything from Plaintiffs’ labelling. (ECF No. 252 at 15.)"

The label has now changed with additional uses by the FDA and for the drug to be ANDA, the labels have to be substantially similar. This is another win for AMRN. The FDA may not approve an ANDA since a substantially similar label cannot be achieved without infringing on the patents.