In addition to Endo Pharmaceuticals Inc and Impax Laboratories LLC,
the lawsuit names as defendants Endo International Plc and Impax's
owner, Amneal Pharmaceuticals Inc, the agency said.
The U.S. Food and Drug Administration had asked Endo in June 2017 to
pull its extended-release oxymorphone product off the market because
of concerns that it was vulnerable to intravenous abuse, the FTC
said.
That left Impax's generic extended-release version of the medicine
alone on the market. Rather than reformulate its drug, Endo struck a
deal with Impax in August 2017 to refrain from re-entering the
market, the FTC said.
"The agreement eliminated potential competition from Endo by sharing
Impax’s monopoly profits, with Endo in the role of a potential
entrant paid to stay out of the market," the FTC said in a
statement.
Endo said in a statement that the lawsuit was "meritless" and that
its agreement with Impax "had no adverse impact on actual or
potential competition."
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"Significantly, as Endo has
explained to the FTC, the company has not
launched or licensed any new opioid product(s)
since that time, and the FTC’s theory that Endo
would do so in the current litigation
environment but for the agreement is
preposterous," Endo Executive Vice President
Matthew Maletta said in a statement. "The
company will vigorously defend itself against
the FTC’s claims."
The agency has previously filed a lawsuit
against the two companies regarding the same
drug, it said.
The five-member commission voted 3-2 to
authorize the lawsuit. The "yes" votes were
acting Chair Rebecca Slaughter, Democrat Rohit
Chopra, who has been nominated to head the
Consumer Financial Protection Bureau, and
outgoing former chairman Joseph Simons.
(Reporting by Diane Bartz in Washington; Editing
by Matthew Lewis and Leslie Adler)
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