Supreme Court agrees to review 'skinny labeling' and generic drug access

[lostincalifornia]

The Supreme Court has agreed to review a controversy over so-called skinny labels for medicines, a decision that will be closely watched for its implications for the availability of generic medicines.

Skinny labeling refers to moves by generic companies that seek regulatory approval to market a medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement.

This tactic has been a linchpin for generic companies ever since the Hatch-Waxman Act went into effect about four decades ago. The federal law established the mechanisms by which generic drugs can more readily enter the marketplace. And skinny labeling, which amounts to a carve-out, is one way that Congress attempted to foster more competition to benefit consumers.

Doubts were raised about the maneuver, however, when the Supreme Court two years ago declined to hear an appeal of a lower court ruling, which questioned the practice. Now, this second case is being seen as a test for whether skinny labeling can survive as a way for generic companies to market medicines, according to legal experts following the issue.

https://www.statnews.com/pharmalot/2026/01/16/scotus-generics-patents-supreme-court-amarin-hikma/

[bucolic_frolic]

1. I'm guessing "off-label" use is something different

but can't tell from the article.