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Pfizer Sues Dexcel Pharmaceuticals Alleging Patent Infringement
The pharma giant is suing Israeli drugmaker Dexcel for developing a generic that would compete with one of Pfizer’s primary revenue-generating medicines.
Early this week, Pfizer and the Scripps Research Institute announced that they would be suing Israel’s Dexcel Pharma for patent infringement affecting Vyndamax, a drug that already generated $818 million in revenue in 2023.
In a July letter to Pfizer, Dexcel shared that it had filed an abbreviated new drug application (ANDA) with the United States FDA. The company claimed that Pfizer and Scripps patents were invalid but did not share evidence or opinion on how that was the case. If Dexcel wins in court, they will begin manufacturing and selling a generic version of Vyndamax in the US.
Pfizer’s patents cover the use of Vyndamax for treating transthyretin amyloid cardiomyopathy (ATTR-CM). The original two patents were filed between 2003 and 2004, and both are set to expire in the next 8 months. A third patent for the use of crystalline tafamidis – the active ingredient in Vyndamax – will expire in 2035.
Pfizer’s annual wholesale cost for the drug is listed at $240,000, and most patients are paying more than $1,000 a month in out-of-pocket costs to cover their medication.
According to the Cleveland Clinic, ATTR-CM occurs when the liver produces abnormal proteins that build up in the heart’s main chamber, leading to an increased risk of heart failure and weakened heart muscle. The disease is common in Black people, and 1 in 25 are estimated to have a changed TTR gene.
Currently, there is no cure for the disease, and the only treatments are Pfizer’s Vyndaqel and Vyndamax, as well as Dolobid, a generic NSAID. Patients have achieved a 13% increase in survival rate using Pfizer's drugs. But even with treatment, ATTR-CM is fatal, with most patients surviving just two or three years after heart failure is present.
Past Cases
In August of this year, Genentech, a subsidiary of Roche, sued Sandoz for infringing on a patent and creating a generic version of the company’s popular lung disease drug, Esbriet. Roche earned $1 billion from Esbriet sales in 2021 and claimed that generic competition would destroy market share. Sandoz filed an NDA with the FDA in 2019 to make generic Esbriet and was promptly sued for infringing on several patents. In that suit, a federal judge ruled against Roche, finding that patents were invalid and allowing Sandoz to commercialize its generic form of the drug. The new lawsuit is based on the validity of a patent filed after the original 2019 case.
In a similar 2007 case, AstraZeneca sued Dexcel for infringing on patents related to Prilosec OTC. Dexcel won that case and was allowed to sell a 20 mg delayed-release formulation of Prilosec that deflated AstraZeneca’s market share.
If Dexcel successfully claims Pfizer’s patents are invalid, the company will likely slash Pfizer’s sales and significantly reduce the cost of Vyndamax for consumers. Currently, Vyndamax is Pfizer’s fourth highest-grossing medication excluding its COVID-19 products.
