Pfizer has successfully warded off three drug manufacturers from placing generics referencing Vyndamax (tafamidis) on the US market, though the countdown to the blockbuster’s loss of exclusivity continues to tick.
In a statement, Pfizer said it has reached agreements with Dexcel Pharma, Hikma Pharmaceuticals and Cipla, all of whom were planning to market generics of its medication used to treat cardiomyopathy transthyretin-mediated amyloidosis (ATTR-CM).
The settlements, which end lawsuits filed by Pfizer alleging patent infringement, push back the US patent expiry for Vyndamax to 2031, though this is pending the outcome of other litigation.
Pfizer’s chief US commercial officer, Aamir Malik, said: "We are very pleased by this outcome, both for patients and in recognition of the value of our innovative science and the strength of our patents.”
Pfizer's tafamidis franchise, which comprises of both Vyndamax and Vyndaqel, generated $6.38bn in 2025, up 17% from 2024. The big pharma company now only sells tafamidis as Vyndamax, after discontinuing Vyndaqel – the lower dose brand – at the end of 2025.
Pfizer had previously forecast a significant decline in US Vyndamax sales upon loss of exclusivity in 2028. With the settlements, Pfizer now anticipates a “relatively stable” stream of revenue from 2028 until mid-2031.
Citi analysts commented: “We expect the estimates for 2028–2031 will likely be revised materially higher. That said, the settlement only delays generic entry rather than eliminating it and remains subject to other litigations.”
ATTR-CM is a rare disease that affects the heart muscle. Patients with ATTR-CM have misfolded transthyretin, which causes the protein to build up in the heart. According to Pfizer, Vyndamax constitutes 75% of prescription volume in the disease market. The drug is the only once-daily capsule approved in the US.
The settlements also have consequences for Vyndamax’s rival Attruby (acoramidis), developed by BridgeBio and approved for ATTR-CM patients. Attruby, a pill taken twice daily, is still in the early stages of launch, having been approved in late 2024, so Pfizer’s legal action is a win for BridgeBio as it looks to establish market share. William Blair analysts believe that Attruby could even grow its patient pool over the next decade despite generics looming.
In a research note, they said: “Investors are viewing [this] as a mixed outcome for BridgeBio, despite being a clearing event and removing a key overhang on the story.
“We believe the payer market is more resilient to a generic entry than commonly perceived and accordingly believe that growth of Attruby could continue despite generic entry.”
