Pfizer secures three patent settlements for Vyndamax, extending exclusivity to mid-2031

Pfizer has reached settlement agreements with three generic drug manufacturers, Dexcel Pharma, Hikma Pharmaceuticals and Cipla, resolving patent infringement lawsuits related to Vyndamax (tafamidis), its treatment for transthyretin-mediated amyloid cardiomyopathy. The settlements extend Vyndamax’s effective US patent expiry to 1 June 2031, subject to the outcome of other ongoing litigation.

The commercial implications are significant. Pfizer had previously anticipated a meaningful revenue decline beginning in 2029 upon patent expiry. Under the new settlement terms, Vyndamax revenues are now expected to remain relatively stable from 2028 through mid-2031, representing a material improvement to the drug’s long-term earnings profile.

Aamir Malik, Pfizer’s Executive Vice President and Chief US Commercial Officer, welcomed the outcome: “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. 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 currently holds 75% of prescription volume within the overall ATTR-CM market. It is the only once-daily capsule approved for the condition with statistically significant reductions in both all-cause mortality and cardiovascular-related hospitalisations, backed by more than seven years of market leadership and data from over 7,000 patients across clinical trials and the largest ATTR-CM registry to date.

Pfizer also confirmed that as of 31 December 2025, it discontinued the supply of Vyndaqel in the United States, with Vyndamax remaining available for eligible patients. The decision followed consultation with clinical experts and patient advocates, who agreed that a single once-daily capsule better supports patient-centred care, particularly for those managing multiple oral medications.

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Pfizer, three patent settlements, Vyndamax