News and Reports | June 4, 2026
WASHINGTON, D.C. — Today, the U.S. Supreme Court unanimously ruled in favor of Hikma in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., preserving a critical pathway that allows lower-cost generic drugs to come to market.
The case focused on “skinny labeling,” a long-standing process that allows generic manufacturers to seek approval for off-patent uses of medicines while still carving out patented uses. In practice, that means a lower-cost generic can come to market for approved uses that are no longer covered by patents, rather than waiting years for every patent associated with the drug to expire.
Generic competition is one of the most effective tools for lowering prescription drug prices; a single generic coming to market can reduce drug prices by 39%, and multiple competitors can drive prices down by as much as 95%.
In response, Patients For Affordable Drugs CEO Merith Basey issued the following statement:
“The Supreme Court’s decision protects an important pathway for bringing lower-cost generic medicines to patients. Had the court ruled the other way, generic manufacturers could have faced increased legal risk when following the rules established by Congress and the FDA. That would have meant fewer generic challenges, delayed competition, and higher drug prices for patients and taxpayers. Competition is one of the most effective mechanisms for lowering prescription drug prices. Today’s decision helps protect that competition and the savings it will deliver to patients.”
Read the full opinion here.
###
Patients For Affordable Drugs is the only national patient advocacy organization focused exclusively on policies that lower prescription drug prices. We empower and mobilize patients by amplifying their experiences with high drug prices to hold those in power to account and fight to shape and achieve system-changing policies that make prescription drugs affordable for all people in the United States. P4AD does not accept funding from organizations that profit from the development and distribution of drugs. To learn more, visit PatientsForAffordableDrugs.org.