What are the "pay-for-delay" concerns around Pfizer's tafamidis patents?
Settlements with three generic rivals push US generic entry from around 2028 to June 2031. The terms have not been made public — which is precisely the problem.
From 2023, several generic manufacturers challenged Pfizer's tafamidis patents. Pfizer sued Dexcel, Hikma and Cipla, and then settled with all three in April 2026. BioPharma Dive noted that such 'pay-for-delay' agreements have long drawn scrutiny from federal regulators as tools that can hold back price competition.
Pfizer had previously expected exclusivity to lapse around 2028. The settlements extend the US generic entry date to June 1, 2031, pending other litigation. The terms have not been made public, so it is not known whether any payment or other value passed to the generic firms - which is the key legal question in pay-for-delay cases under FTC scrutiny.