The End of Cheap Generic Drugs? How a New Court Ruling Could Lock in High Prices

A Supreme Court case heard this week could give brand-name drugmakers longer monopolies, delay generic competition, and leave patients paying higher prices.

When it comes to generic medications, Americans benefit from lower prices than patients in any other comparable country, but that deal doesn’t come quickly. Some brand-name drugs enjoy monopolies lasting decades before a generic version can enter the market. Now, a case before the Supreme Court could stretch that wait even further.

Hikma v. Amarin centers on a practice called skinny labeling that allows generic drugmakers to bring cheaper medications to market more quickly. The case involves Vascepa—Amarin’s brand-name fish oil-derived drug for patients at high risk of heart disease—which generic maker Hikma sought to compete with using this very approach.

When a brand-name manufacturer holds patents on only some uses of a drug, generic competitors can seek FDA approval to sell their version exclusively for the unpatented uses which bypasses costly litigation.

The approach has proven both effective and economical. Over the last decade, more than two dozen generic drugs have reached the market this way, including versions of major blockbusters like Crestor, the widely used cholesterol-lowering medication. By accelerating low-cost competition, skinny labeling saved Medicare nearly $15 billion between 2015 and 2021, according to a 2024 study in the Annals of Internal Medicine.

For this case, Amarin had patented Vascepa for two distinct patient groups: those at very high risk for heart disease and those at lower risk. When the patent covering the higher-risk use expired, Hikma entered the market with a skinny label approval in 2020, cleared to sell its generic only for that unpatented use. Amarin then sued, alleging that Hikma had encouraged doctors to prescribe the generic for the still-patented use as well.

Amarin takes issue with several of Hikma’s practices, among them, marketing the drug as a generic version of Vascepa without disclosing its narrower approval. However, more than 70 legal scholars and the Trump administration’s solicitor general have weighed in on Hikma’s behalf.