Just four years into the rollout of Pfizer's pricey heart medication Vyndamax, the company is already playing patent defense against a potential copycat.
In a new lawsuit, the drug giant and the Scripps Research Institute claim Dexcel Pharma steps on three of their patents with its proposed generic.
The lawsuit comes after Dexcel in June told Pfizer it would seek FDA approval for its generic. Pfizer's Vyndaqel and Vyndamax treat heart disease caused by transthyretin mediated amyloidosis, and Dexcel plans to target the same indication.
In their suit, Pfizer and Scripps argue the Israeli company has acted “with full knowledge” of the alleged patent violations.
Vyndamax, along with sister product Vyndaqel, brought Pfizer sales of $782 million during this year’s second quarter, a 42% increase from last year. The franchise is a top growth driver for Pfizer at a time when sales from its pandemic countermeasures decline rapidly.
The two drugs have attracted significant pricing scrutiny since their 2019 approvals. In 2020, researchers Matthew Maurer, M.D., and Jerry Gurwitz, M.D., said they were the priciest cardio drugs on the market, carrying list prices of $225,000 per year.
A 2020 study led by the two researchers found that many patients who were prescribed these drugs needed financial assistance to afford them. Before any financial assistance, the median 30-day out-of-pocket cost was $1,909, the team found. In a statement to Fierce Pharma at the time, Pfizer placed blame on "unfair" co-pays under the Medicare Part D benefit design.
Pfizer has attempted to address the high co-pays needed for these medicines with a proposed program to provide financial help to Medicare patients. But U.S. law prohibits such payments, and Pfizer took a lawsuit challenging the law all the way to the Supreme Court.
The Supreme Court rejected the plan in January, siding with two lower courts.