Teva and the US government are in talks to settle a lawsuit against the company alleging a kickback scheme for its blockbuster multiple sclerosis drug Copaxone.
In court documents filed over the weekend with the United States Court of Appeals for the First Circuit, Teva wrote that both the company and the US government “are actively engaged in settlement negotiations and Teva is optimistic that the parties can reach a resolution, but additional time is needed to do so.”
A representative for Teva declined to comment further.
The government filed the lawsuit in 2020, alleging that Teva violated the False Claims Act by paying over $300 million to two foundations — the Chronic Disease Fund and The Assistance Fund — between 2006 and at least 2015 to cover Medicare copays for Copaxone patients, thus generating false claims to Medicare and revenue for itself.
In court documents, the government claimed that while Teva was subsidizing Copaxone’s cost through the two charities, it also raised the price of Copaxone from approximately $17,000 per year to over $73,000 per year.
In Teva’s answer to the government’s complaint, Teva denied the allegations, though it did admit it made donations to the two charities and the price of Copaxone did increase during that time period.
Copaxone has been facing generic competition since 2015. The drug first won approval in the US in 1996 as the first non-interferon treatment for relapsing-remitting multiple sclerosis. Teva then launched a version that could be taken three times a week as opposed to daily, as the drug was approaching a 2015 patent cliff.
The company has also faced other allegations of anticompetitive practices, including in the EU in 2022, when it was accused of misusing the patent system and spreading misinformation about the safety and efficacy of a rival product.
While Copaxone hauled in $4.2 billion in 2014, Teva’s 2024 outlook plans for about $400 million in sales.