Sept 23 (Reuters) - Amneal Pharmaceuticals ( AMRX ) has
sued Colorado in an effort to block a state law requiring it to
provide free generic EpiPens to pharmacies.
In a complaint filed on Friday in federal court in Denver,
Colorado, New Jersey-based Amneal said that the law, which was
passed last year and took effect in January, was an illegal
taking of its property under the 5th Amendment of the U.S.
Constitution.
The law aims to bring down the often high costs of
auto-injectors like Viatris' ( VTRS ) EpiPen, handheld devices
that treat life-threatening severe allergic reactions by
automatically injecting a dose of the drug epinephrine.
It requires all health insurance plans that cover
auto-injectors to provide them at a cost of no more than $60 for
a two-pack, a requirement that Amneal is not challenging.
The law also requires pharmacies to provide the injectors
with the same $60 price cap to people whose insurance does not
cover them, and manufacturers in turn to provide the pharmacies
with a free replacement or reimbursement for each injector sold
under that requirement.
The company's generic version of the device Adrenaclick,
which was approved in 2018, generally costs more than $100
without insurance, while a pack of brand-name EpiPens can cost
as much as $700.
Amneal said it has had to replace 304 injectors since the
program began.
"Colorado's reimburse-or-resupply requirement plainly
effects an unconstitutional, 'per se physical taking' of
Amneal's personal property in violation of the Fifth Amendment,"
it said, asking the court to issue an order blocking enforcement
of the law.
The office of Colorado Attorney General Philip Weiser
declined to comment.
Viatris ( VTRS ) drew harsh criticism from U.S. lawmakers in 2016 for
increasing the price of EpiPens sixfold in less than a decade.
It reached a $465 million settlement with the U.S.
Department of Justice in 2017 over claims that it used
anticompetitive tactics to drive up the price, and in 2022
agreed to pay $264 million to settle related private litigation.
Pfizer ( PFE ), which manufactured the product for Viatris ( VTRS ), has also
reached settlements with private plaintiffs totaling almost $400
million.
The case is Amneal Pharmaceuticals ( AMRX ) v. Weiser, U.S. District
Court for the District of Colorado, No. 1:24-cv-02609.
For Amneal: Jay Lefkowitz of Kirkland & Ellis
For Colorado: not yet available
Read more:
Mylan, U.S. finalize $465 million EpiPen settlement
EpiPen antitrust litigation settled; Viatris ( VTRS ) to pay $264
million
Pfizer ( PFE ) to pay $50 mln to settle drug wholesalers' EpiPen
antitrust claims
(Reporting By Brendan Pierson in New York)