Endo reaches deal with FTC over pay-for-delay allegations
- Endo Pharmaceuticals put to rest one of its many legal troubles on Monday, announcing an agreement with the Federal Trade Commission that resolves allegations the Irish pharma paid off rivals to keep generic competition from entering the U.S. market.
- Under a proposed order, Endo will forswear making any so-called pay-for-delay deals with generic manufacturers to protect its branded products — something which the company says is already part of its current policy for settling patent infringement cases.
- Endo won't be required to make any payments under the agreement with the FTC, which has released Endo from potential liability in a separate case involving reverse-payment deals for its drug AndroGel.
The FTC sued Endo back in March, accusing the company of paying Impax Laboratories $112 million in a deal designed to give Endo time to introduce and patent a new form of its painkiller Opana ER. In return, Endo allegedly pledged not to launch an authorized generic of Opana, reducing competition for Impax when it did launch its generic Opana.
The proposed order, which requires court ratification, prohibits Endo from entering into any of those so-called "no-AG," or no authorized generic, deals, along with any other pay-for-delay settlements.
Endo insists that's already part of its current practice. And, according to Endo's chief legal officer Matthew Malleta, the absence of a monetary fine or admission of guilt validates Endo's belief its original Opana settlements were in compliance with the law.
The FTC also revived related charges it made against Watson Laboratories and its former parent company Allergan. Endo had allegedly paid Watson and Allergan hundreds of millions of dollars to delay market entry of a copy of Endo's Lidoderm patch.
Those charges had been voluntarily dismissed by the FTC in November so that it could refile in California district court. The FTC is seeking a similar injunction barring pay-for-delay deals as well as disgorgement of gains.
A spokesperson for Allergan had no comment on the refiled charges.
- FTC Press release
- FTC Complaint
- Endo Press release
- BioPharma Dive FTC alleges Endo struck illegal deals to delay release of generic drugs
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