Pfizer Reaches Three Settlement Agreements to Extend U.S. Patent Exclusivity for VYNDAMAX® Until June 2031

PharmaCircleMonitoring shows that: On April 28, Pfizer Inc. (NYSE: PFE) and generic drug companiesDexcel Pharma, Hikma Pharmaceuticals, and Cipla Ltd Reach Settlement AgreementThe series of litigations, accepted by the U.S. District Court for the District of Delaware, focuses on patent infringement disputes related to VYNDAMAX® (tafamidis), a drug for treating transthyretin-mediated amyloidosis cardiomyopathy (ATTR-CM).

This settlement extends the effective expiration date of VYNDAMAX's U.S. patent to June 1, 2031, with the final outcome still contingent upon the results of other related litigations.Previously, Pfizer predicted that due to the impact of patent expiration, the revenue from VYNDAMAX in the U.S. market would significantly decline starting from 2029; however, based on this settlement, it is now expected that the drug’s revenue will remain relatively stable from 2028 through mid-2031.

Pfizer Executive Vice President and Head of U.S. Commercialization, Aamir Malik, stated: "We are very satisfied with this settlement outcome, whether viewed from the perspective of patient benefits or based on the recognition of the value of corporate innovation and the effectiveness of patent protection. We will continue to uphold our commitment to the diagnosis and treatment of ATTR-CM patients, leveraging our market-leading advantages and clinical service experience to continuously deliver the clinical value and therapeutic benefits of VYNDAMAX, helping more patients suffering from this severe disease with low diagnostic rates receive standardized treatment."

Currently, VYNDAMAX still firmly holds the top position in the overall ATTR-CM market, with a prescription volume market share of 75%. This drug is the only daily single-dose oral capsule formulation approved for ATTR-CM treatment. Clinical studies have confirmed that it can significantly reduce all-cause mortality and cardiovascular-related hospitalization risks, with a safety profile similar to placebo. Supported by over seven years of market application, clinical trial data covering more than 7,000 subjects, and data from the largest current ATTR-CM disease registry study, its clinical application value is fully evidenced.

As of December 31, 2025, Pfizer has discontinued the supply of VYNDAQEL in the United States. Patients who meet the treatment criteria for the indication can continue to use VYNDAMAX. This decision was made after consultation with clinical experts and patient advocacy groups, who unanimously agreed that a once-daily oral dosing regimen aligns better with patient-centered care principles, enhances medication convenience, and is particularly suitable for patients with multiple comorbidities who need to take various oral medications simultaneously.

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