Global pharma giant Pfizer has struck settlement pacts with generic drugmakers Dexcel Pharma, Hikma Pharmaceuticals, and Cipla in long-running US patent litigation over its heart medication.

 

VYNDAMAX (tafamidis) is used to treat transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM).

 

The deals, tied to cases in the US District Court for the District of Delaware, effectively extend US patent protection for VYNDAMAX until June 1, 2031—though the timeline remains subject to the outcome of other ongoing litigation. 

 

The extension significantly reshapes Pfizer’s revenue outlook for the drug, which had been expected to face steep erosion beginning in 2029.

 

Instead, Pfizer now anticipates a far more stable performance window, with revenues projected to hold steady from 2028 through mid-2031.

 

"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," said Aamir Malik, Executive Vice President and Chief US Commercial Officer, Pfizer. 

 

"Our focus continues to be our unwavering commitment to patients with ATTR-CM. With our market leadership and physician experience, we remain confident in the value and benefits of VYNDAMAX as we work to reach more patients living with this serious and underdiagnosed disease."

 

VYNDAMAX continues to dominate its category, holding roughly 75% of prescription volume in the ATTR-CM market. It is the only once-daily capsule approved for the condition, supported by clinical data showing statistically significant reductions in both all-cause mortality and cardiovascular hospitalizations, with a safety profile comparable to placebo.

 

Pfizer says the therapy is backed by more than seven years of real-world use and data from over 7,000 patients across trials and the largest ATTR-CM registry to date.