The U.S. Federal Trade Commission (FTC) has filed a complaint in federal district court that alleges Endo Pharmaceuticals and other companies blocked consumers' access to lower-cost generic versions of two pain medications, including an opioid.
Filed on March 31 in the U.S. District Court for the Eastern District of Pennsylvania, the complaint alleges that Endo Pharmaceuticals paid Impax Laboratories and Watson Laboratories (now Actavis) in pay-to-delay patent settlements to delay generic drug entry and eliminate the risk of competition for two pharmaceutical products: Opana ER and Lidoderm. Impax and Watson were the first companies to file for U.S. Food and Drug Administration (FDA) approval for generic versions of the pharmaceuticals, according to an FTC statement.
Opana ER is an extended-release opioid and Lidoderm is a lidocaine topical patch used to relieve pain associated with postherpetic neuralgia, according to the FTC.
This complaint is the first FTC case challenging an agreement not to market an authorized generic (AG). These agreements are known as a "no-AG commitment" and violate the Federal Trade Commission Act, according to the commission.
"Settlements between drug firms that include 'no-AG commitments' harm consumers twice -- first by delaying the entry of generic drugs and then by preventing additional generic competition in the market following generic entry," stated FTC Chairwoman Edith Ramirez. "This lawsuit reflects the FTC's commitment to stopping pay-for-delay agreements that inflate the prices of prescription drugs and harm competition, regardless of the form they take."