Hikma Pharmaceuticals PLC

Dudenhofer did it for allegations based on insider information.

Hikma did it most recently for allegations based on inaction.

The meaningful benchmark standard does the same thing for allegations that a fund cost too much or didn't earn enough.

I welcome the court's questions.

Welcome to episode 58 of the Supreme Court Opinions Red podcast, where we read Supreme Court opinions so you don't have to.

My name is Bailey, and I'll be reading the Supreme Court's opinion in Hikma Pharmaceuticals USA vs. Ameren Pharma.

The case was decided June 4th, 2026.

And as always, we'll begin with the syllabus.

In 2012, the FDA approved Vesepa for the treatment of severe hypertrichlyceridemia, the SH indication, In 2019, the FDA approved Vasepa for a second, more common use, reducing cardiovascular risk in hypertriglyceridemia patients who already take statins, the CV indication.

Ameren obtained two method-of-use patents for this indication.

Hikma Pharmaceuticals USA, Inc., a generic drug manufacturer, submitted an abbreviated new drug application for generic icosapent ethyl in 2016.

It initially filed a Paragraph 4 certification, C-21 USC Section 355J2A74, asserting that Ameren's SH indication patents were invalid.

Amnil has both 100 and 200 milligram progesterone capsules on back order with no estimated date of release.

Hikma has some progesterone products on allocation and others on backorder.

Fortunately, other manufacturers still have products available, including generic Prometrium and some other types of generic progesterone.

And this matters because if a woman has a uterus and she wants to use an estrogen patch or other form of estrogen, she actually needs to use the progesterone with it to protect the uterine lining so she doesn't get uterine cancer.