However, during this time period, some Endo Pharmaceuticals sales managers allegedly provided instructions to sales representatives, outlining how to expand sales conversations with doctors beyond the treatment of PHN and into the treatment of non-PHN related symptoms, including lower back pain, diabetic neuropathy, and carpal tunnel syndrome. The Lidoderm pain patch was only approved to treat symptoms of Post Herpetic Neuralgia (PHN), a rare disease which is a complication of Shingles, although according to the lawsuit Endo Pharmaceuticals also marketed it for other uses.īetween 20, Lidoderm was approved by the FDA only for the use described above. The lawsuit was brought under the qui tam provision of the False Claims Act, which allows private whistleblowers to bring claims in the name of the government for fraud of government-funded healthcare programs, such as Medicare and Medicaid.

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 Department of Justice announced last week that Endo Health Solutions and its subsidiary, Endo Pharmaceuticals, have agreed to pay $192.7 million to settle healthcare whistleblower allegations of off-label marketing of a pain treatment patch called Lidoderm. 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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