What is the controversy over Vyndamax's patents and generic entry?
Settlements with three generic makers extend US entry to June 2031 — from an expected 2028 — on undisclosed terms, drawing scrutiny as potential "pay for delay" arrangements that BioPharma Dive notes have long attracted federal antitrust concern.
Tafamidis was expected to lose exclusivity around 2028. From 2023, generic makers challenged its patents; Pfizer sued Dexcel, Hikma and Cipla and settled with all three in April 2026. The settlements extend the US generic entry date to June 1, 2031, pending other litigation, and BridgeBio's CEO has said Pfizer's broader patent estate, including crystalline form patents, extends to 2035. BioPharma Dive noted that "pay for delay" agreements have long drawn scrutiny from federal regulators as tools to impede price competition. The terms have not been disclosed, so whether Pfizer transferred value to the generic companies, the key test under antitrust law, is unknown.