NEW YORK - Pfizer Inc. (NYSE: PFE) announced in a press release that it has entered into settlement agreements with generic drug manufacturers Dexcel Pharma, Hikma Pharmaceuticals and Cipla Ltd, regarding lawsuits filed in the US District Court for the District of Delaware for infringement of patents relating to VYNDAMAX® (tafamidis), a treatment for cardiomyopathy transthyretin-mediated amyloidosis (ATTR-CM).
These settlements extend the effective U.S. patent expiry date for VYNDAMAX to June 1, 2031, subject to the outcome of other litigation. Pfizer had previously anticipated a significant decline in U.S. revenues for VYNDAMAX beginning in 2029 upon patent expiry. As a result of this settlement, revenues are now expected to remain relatively stable 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 U.S. 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 remains the market leader with 75% of prescription volume within the overall ATTR-CM market. As the only once-daily capsule approved for ATTR-CM with statistically significant reductions in both all-cause mortality and cardiovascular-related hospitalizations with a demonstrated safety profile comparable to placebo, VYNDAMAX is backed by over seven years of market leadership and data from more than 7,000 patients across clinical trials and the largest ATTR-CM registry to date.
As of December 31, 2025, Pfizer 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-capsule taken once daily enhances patient-centered care and convenience, particularly for those with concomitant conditions requiring multiple oral medications.
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At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.