The Federal Trade Commission has filed a complaint against Malvern’s Endo Pharmaceuticals and several other drug companies in federal district court, alleging they violated antitrust laws, writes John George for the Philadelphia Business Journal.
According to the FTC, this is the first case to challenge the “no-AG commitment” which is the agreement not to market an authorized generic as a form of reverse payment. In the complaint, Endo is accused of using pay-for-delay settlements to block consumer access to the lower-cost generic versions of Lidoderm and Opana ER. Lidoderm is used to relieve the pain of shingles post-herpetic neuralgia, and the extended-release opioid Opana ER helps alleviate moderate to severe pain.
The FTC’s complaint alleges that Endo violated the Federal Trade Commission Act by trying to eliminate the risk of competition for its drugs by paying Impax Laboratories and Watson Pharmaceuticals, the first generic companies that filed for FDA approval of these drugs, to delay their products introduction.
“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 Edith Ramirez, the FTC Chairwoman. “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.”
Endo claims the FTC’s case is without merit and plans to fight the complaint.
“Endo is disappointed by the FTC’s decision to initiate litigation over intellectual property settlements Endo reached in 2010 and 2012 with Impax Laboratories and Watson Pharmaceuticals, respectively. Endo believes that both settlements were supportive of a competitive environment for a number of reasons, including that they permitted the entry of generic competition to Endo’s branded pharmaceutical products well before the relevant patents expired and, therefore, benefitted consumers through increased availability and lower pricing. Because the settlements complied with all applicable laws, we believe the FTC’s case is without merit and Endo intends to vigorously defend itself in the litigation.”
To read more about FTC case against Endo, visit the Philadelphia Business Journal here.
