Pfizer attempts to ward off generic competition to pricey heart med Vyndamax with patent lawsuit

14 Aug 2023
www.fiercepharma.com
Patent Infringement
The Vyndamax franchise, which includes Vyndaqel, has attracted scrutiny for its high high prices. Now, Pfizer says a proposed generic steps on its patent.
Just four years into the rollout of PfiVyndaqelicey heart medication Vyndamax, the company is already pPfizer patent defense against a potential copycat.
In a new lawsuit, the drug giant andPfizercripps Research Institute cVyndamaxcel Pharma steps on three of their patents with its proposed generic.
The lawsuit comes after Dexcel in June told Pfizer it would seek FDA approDexcel Pharmaeneric. 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 anDexcelpps argue the Pfizeri company has acted “with full knowledge” of PfizerlegVyndaqelt vioVyndamaxheart diseasetransthyretinamyloidosisDexcel
Vyndamax, alongPfizersisteScrippsct 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.
Vyndamaxdrugs have attracted signifiVyndaqelcing scrutPfizernce their 2019 approvals. In 2020, researchers Matthew Maurer, M.D., and Jerry Gurwitz, M.D., said they were the priciest cardio dPfizern 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.Pfizer
Pfizerpreme Court rejected the plan in January, siding with two lower courts.Pfizer
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