Anna Bradley-Smith  |  June 3, 2021

Category: Legal News

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Amarin Pharma ran an unlawful scheme to prevent generic competition for Vascepa by hoarding the world’s supply of icosapent ethyl, class action lawsuit alleges
(Photo Credit: Ekaterina Batsuknova/Shutterstock)

 Amarin Pharma and affiliates locked up the world’s supply of hyperglyceridemia medication Vascepa in an anticompetitive scheme designed to prevent generic competition, a new class action lawsuit alleges.

The Vascepa antitrust class action, which covers more than 40 US states and territories, was filed in New Jersey on June 2 by the Uniformed Fire Officers Association Family Protection Plan Local 854 and the Uniformed Fire Officers Association for Retired Fire Officers Family Protection Plan. The two health insurance providers allege that Amarin Pharma, Inc. and its affiliates violated state and federal antitrust laws and severely damaged consumers.

Amarin ran an unlawful scheme to prevent generic competition for Vascepa by hoarding the world’s supply of icosapent ethyl, or IPE, the active pharmaceutical ingredient needed to make the drug, according to the Vascepa antitrust class action lawsuit against Amarin.

“Notably, Amarin has repeatedly touted its anticompetitive scheme to investors, often coyly referring to ‘taking advantage of manufacturing barriers to entry,’ but sometimes bluntly stating that the addition of a new supplier ‘fortifies Amarin’s efforts to shield its Vascepa patent beyond its scheduled 2030 expiration’,” the class action lawsuit states.

Vascepa is the brand name for the icosapent ethyl drug product marketed by Amarin, manufactured using the active pharmaceutical ingredient IPE, which is derived from eicosapentaenoic acid, a type of omega-3 fatty acid derived from fish oil.

Vascepa has been shown both to lower triglycerides and to reduce the risk of cardiovascular events in patients who have high triglycerides, and in 2020, annual sales of Vascepa in the United States were over $600 million, the Vascepa class action lawsuit states.

However, Amarin has had an unlawful monopoly over the drug and inflated its price, the class action contends, after it cut off outside supply to the active ingredient when the courts ruled other pharmaceutical companies could make generic brand Vascepa.

“After its patent victory, DRL promptly began preparations to launch generic Vascepa, ‘only to discover that Amarin had foreclosed all the suppliers of the icosapent ethyl API who have sufficient capacity to support a commercial launch in a timely manner’,” the Vascepa class action lawsuit states.

It says that pharmaceutical companies DRL and Hikma were entirely foreclosed from entering the market due to Amarin’s use of a series of exclusive contracts and other anticompetitive conduct to lock up the world’s supply of icosapent ethyl, a key ingredient for Vascepa.

The Vascepa class action lawsuit alleges that Amarin contracted with at least four different manufacturers – one or two is standard in the pharmaceutical industry – using agreements that prevent the suppliers from selling icosapent ethyl to any other manufacturer.

“Amarin had secured a supply of several times Amarin’s own needs based on its anticipated sales,” the claim states.

As a result of Amarin’s scheme, DRL’s launch of generic Vascepa has been delayed since August 2020, Hikma’s launch of generic Vascepa has been constrained by limited supply, and consumers and insurance providers have been forced to pay anticompetitive prices for Vascepa and its generic equivalent, the Vascepa class action lawsuit states.

The lead Plaintiffs in this Vascepa class action lawsuit against Amarin Pharma are insurance providers who want to represent anyone who bought Vascepa in Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming, the District of Columbia, and Puerto Rico.

They are suing for Violation of Section 1 of the Sherman Act, monopolization and conspiracy under state laws, and deceptive trade and unjust enrichment, and seek certification of the Class, damages, injunctive relief, legal fees, and a jury trial.

In a similar case, drug manufacturer Actavis recently signed a $1.1 million settlement with parents and caregivers of children suffering from attention deficit hyperactivity disorder, settling allegations the company delayed releasing its generic ADHD medication.

Have you ever been forced to pay a higher price for medication while waiting on the release of a generic version? Let us know in the comments section!

The insurers are represented by James E. Cecchi and Lindsey H. Taylor of Carella, Byrne, Cecchi, Olstein, Brody & Agnello, P.C., Lee Albert, Brian Murray, Greg Linkh, Brian Brooks of Glancy Prongay & Murray LLP, Roberta D. Liebenberg and Adam J. Pessin Fine of Kaplan and Black R.P.C., Joseph H. Meltzer, Terence S. Ziegler, Ethan J. Barlieb and Lauren M. McGinley of Kessler Topaz Meltzer & Check, LLP, and Michael E. Criden, Kevin B. Love and Lindsey C. Grossman of Criden & Love, P.A.

The Vascepa Antitrust Class Action Lawsuit is Plaintiffs Uniformed Fire Officers Association Family Protection Plan Local 854, et al. v. Amarin Pharma, Inc., et al., Case No. 2:21-cv-12061, in the U.S. District Court of New Jersey.


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4 thoughts onAmarin Pharma Hoarded World’s Supply of Key Drug Ingredient to Prevent Competition, Class Action Alleges

  1. Michael Everts says:

    This is total BS.
    First: Generics applied to the FDA in 2016 with approval in 2020. They should have prepared for launch years ago as Amarin did.
    Second: There is plenty of supply for “non-infringing” use by generics. Anything over the current supply is clearly for infringing use.
    Third: In many cases, the branded name VASCEPA is cheaper than the generic when used with coupon.

  2. Goodman says:

    If Amarin locks the active ingredients due to it’s own requirements based on their “Vascepa” approval, i.e., in USA, Europe, Canada and future requirements (or approvals) in China & rest of the world, may be by 4Q21. This is planning ahead in business and What is wrong with this activity? I don’t understand the reason for this Anti trust law. I think Amarin must give up their requirements to the competing generics so that all generics will be happy and thankful to Amarin in return !! Is this called business?…

  3. Jc says:

    Theres a reason for this …dig a little deeper as to why the generics dont need the supply. Infringement..

  4. Bob Bobster says:

    The article states “Vascepa has been shown both to lower triglycerides and to reduce the risk of cardiovascular events in patients who have high triglycerides,”

    Generics are approved for the lower triglycerides indication, though this is being appealed to the supreme court due to some dopiness during the patent trial. At most this patient population is 10% of the population that could be taking Vascepa.

    Generics are not approved for the CVD indication.

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