This refers to a process whereby a generic or follow-on drug company tries to gain regulatory approval to market a drug product for one or more — but not all — of the uses for which an already-patented drug has been approved. For example, STAT reported, a generic drug could be marketed to treat one type of heart problem but not another as covered by a brand-name drug. By doing so, the generic company seeks to avoid lawsuits from the main manufacturer claiming patient infringement.
Deeper dive
Under the federal Hatch-Waxman Act, a company that files an abbreviated new drug application with the Food and Drug Administration may seek approval only for indications not covered by the brand’s patents, with some allowed carve-outs. Since this product won’t cover all of the uses of an approved, branded drug, it’s known as a “skinny label.” It can help foster more competition and keep drug prices lower, STAT reported.
This strategy has been used by generic drug and biosimilar manufacturers.
In January 2026, the U.S. Supreme Court agreed to review a case over a patent dispute with Amarin Pharma’s cardiovascular drug Vascepa and Hikma Pharmaceuticals, a large generic manufacturer, Reuters (and other news sources) reported.
Amarin has regulatory approval to treat a condition called severe hypertriglyceridemia (elevated triglycerides in the blood) and for reducing cardiovascular risks in certain patient populations. The company filed a lawsuit five years ago accusing Hikma of infringing on three patents; the company sought FDA approval only for high triglycerides and not the other uses. But Amarin said the language Hikma used in its product label could lead to doctors prescribing the medicine both for high triglycerides and cardiovascular risk. This argument has been ongoing through the courts and could have implications for the future of skinny labeling, STAT reported in January 2026.