US Supreme Court backs generic drugmaker in 'skinny label' patent case

• Hikma used a 'skinny label' approved by the FDA that omitted Vascepa's patented use for non-severe hypertriglyceridemia, listing only the treatment for severe hypertriglyceridemia
• Amarin earned $213.6 million from Vascepa sales in 2025, making it the company's only product, while generic drugs have saved an estimated $2.9 trillion over the past decade
• The Trump administration supported Hikma's appeal, with generic drugmakers arguing that a ruling for Amarin would discourage lower-cost drug production and increase U.S. drug prices

US Supreme Court Backs Generic Drugmaker in 'Skinny Label' Patent Dispute

The U.S. Supreme Court unanimously ruled (9-0) on June 4 in favor of Hikma Pharmaceuticals, determining its generic version of Amarin Pharma's cardiovascular drug Vascepa did not infringe Amarin's patents. The decision overturned a lower court ruling and establishes important precedent for "skinny label" generic drugs.

Key Details:

Vascepa, a fish oil-derived medication that lowers triglycerides and reduces heart disease risk, is Amarin's sole product, generating $213.6 million in revenue in 2025. The FDA initially approved Vascepa in 2012 for severe hypertriglyceridemia, then expanded approval in 2019 for less-severe cases.

London-based Hikma received FDA approval for its generic version with a "skinny label" covering only the severe hypertriglyceridemia indication, omitting the less-severe use still protected by Amarin patents. Amarin sued Hikma in Delaware federal court in 2020, claiming Hikma's marketing materials encouraged off-label prescribing for infringing uses.

Market Implications:

The ruling protects generic drugmakers from patent infringement lawsuits when using skinny labels to avoid patented uses. Generic manufacturers and the Trump administration argued that allowing such lawsuits would discourage generic competition and increase drug prices. Hikma noted generic drugs have saved patients and insurers approximately $2.9 trillion over the past decade.

The decision makes it easier for generic companies to enter markets with partial indications, potentially accelerating generic competition and lowering healthcare costs. Notably, Amarin had not sued seven other generic Vascepa manufacturers, suggesting this case involved exceptional circumstances.