![]() ![]() ![]() Impax refused and Endo sued for breach of the 2010 settlement’s good faith negotiation clause. In 2015, Endo demanded that Impax pay it an 85% royalty for its license to the later-issued patents. But not Impax the 2010 settlement licensed Impax for these additional patents. ![]() Patent and Trademark Office issued Endo additional patents covering Opana ER-including a patent that is set to expire in November 2029. Through these newly issued patent, Endo prevented all producers of generic Opana ER from launching until 2029. The settlement required Endo and Impax to “negotiate in good faith an amendment to the terms of the License to any patents.” 5 Nine other companies sought to market generic Opana ER products Endo sued and settled with each. None of these later settlements included a license for future patents as Impax had received. The settlement ensured that Impax could sell its generic even if Endo later obtained additional patents covering the drug. In the 2010 settlement, Endo provided Impax with a license to any then-issued as well as any future patents that could cover Opana ER. That withdrawal left Impax’s generic as the only available extended release oxymorphone product on the market. Food and Drug Administration’s demand that Endo pull a reformulated crush-resistant version of Opana ER from the market due to its increased intravenous abuse. The 2017 settlement, FTC alleged, resulted from the U.S. In 2017-the same year that Endo settled the first FTC suit-Endo and Impax reached another deal regarding Opana ER, resolving a breach of contract dispute over the 2010 settlement. ![]() District Court for the Northern District of Illinois against both Endo and Impax related to the 2010 settlement. 2 Private class action litigation remains pending in the U.S. In April 2021, the Fifth Circuit affirmed the FTC’s finding that the 2010 settlement was an unlawful reverse payment deal. Under that 2010 settlement, Endo paid Impax more than $100 million to keep Impax’s generic off the market until 2013. Endo settled the first FTC lawsuit in 2017 Impax did not. The FTC had previously prevailed in a challenge of a 2010 settlement between Endo and Impax that ended patent litigation over the same drug. The FTC is seeking a court judgment declaring that the defendants’ conduct violates the antitrust laws, ordering the companies to disgorge their ill-gotten gains, and permanently barring them from engaging in similar anticompetitive behavior in the future.Įndo agreed to settle the charges in a proposed stipulated order to be entered by the court.The FTC filed this case in January 2021, claiming that Endo and Impax’s 2017 settlement, in which Endo allegedly promised to stay off the Opana ER market, violated the Sherman Act. According to the FTC, a no-AG commitment can be extremely valuable to the first-filer generic, because it ensures that this company will capture all generic sales and be able to charge higher prices during the exclusivity period. But a branded drug manufacturer is permitted to market an authorized generic version of its own brand product at any time, including during the 180 days after the first generic competitor enters the market. Under federal law, the first generic applicant to challenge a branded pharmaceutical’s patent, referred to as the first filer, may be entitled to 180 days of exclusivity as against any other generic applicant upon final FDA approval. Lidoderm is a topical patch used to relieve pain associated with post-herpetic neuralgia, a complication of shingles. – to eliminate the risk of competition for Lidoderm, in violation of the Federal Trade Commission Act. The FTC’s complaint alleges that Endo paid the first generic companies that filed for FDA approval – Watson Laboratories, Inc. The agreement not to market an authorized generic – often called a “no-AG commitment” – is the form of reverse payment. and several other drug companies violated antitrust laws by using pay-for-delay settlements to block consumers’ access to lower-cost generic versions of Lidoderm. The FTC's complaint alleges that Endo Pharmaceuticals Inc. About the FTC Show/hide About the FTC menu items.News and Events Show/hide News and Events menu items.Advice and Guidance Show/hide Advice and Guidance menu items.Competition and Consumer Protection Guidance Documents.Enforcement Show/hide Enforcement menu items. ![]()
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