Class Action Claims Actelion Inflated Prices of Bosentan by Blocking Generic Alternatives

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A proposed class action out of Maryland claims Actelion Pharmaceuticals overstepped federal law in its apparent attempts to maintain a monopoly over bosentan, a prescription drug used to treat pulmonary artery hypertension that the company sells under the brand name Tracleer. Specifically, the case alleges Actelion unlawfully barred generic manufacturers from releasing generic versions of the drug, which would have lowered prices for consumers.

The lawsuit – which names as defendants Actelion Pharmaceuticals Ltd., Actelion Pharmaceuticals US, Inc., and Actelion Clinical Research, Inc. – claims the defendants' scheme hinged on their refusal to provide generic competitors with samples of Tracleer. According to the complaint, Actelion guaranteed that samples of its profitable brand were inaccessible by including restrictive language in distributors’ contracts and refusing to sell to generics manufacturers directly. The suit explains that the approval of generic versions of branded drugs requires that manufacturers run a series of comparison tests to “establish that the brand and the generic are bioequivalent.” Without samples of Tracleer, would-be competitors were prevented from securing FDA approval for bosentan generics, the case says.

Actelion supposedly cited FDA safety protocols as the reason for denying to provide Tracleer samples. The case notes that the drug can cause “serious liver damage and birth defects” if taken during pregnancy, which prompted the FDA to require that Actelion implement a Risk Evaluation and Mitigation Strategy (REMS).  Actelion’s insistence that its REMS allows it to deny samples of the drug to generic manufacturers notwithstanding, the case notes Congress has held that REMS “may not be used to delay generic competition.”

“Nothing in the REMS statute, the [Elements To Assure Safe Use] provision, or elsewhere in the applicable statute prohibits the sales of REMS-controlled drugs to qualified generic companies that will use those drugs in controlled, FDA-required bioequivalence testing,” the complaint reads.

The lawsuit argues that Actelion’s “years-long blockade” violates federal antitrust laws and has caused consumers to overpay for bosentan prescriptions since 2015.