Pfizer Reaches Three Settlement Agreements for VYNDAMAX
Pfizer Reaches Three Settlement Agreements for VYNDAMAX
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tafamidismedical
Tafamidis is a prescription medicine that helps slow progression of certain diseases caused by misfolded transthyretin protein, most notably forms that affect the heart and nerves. For investors, it matters because its approval status, patent protection, pricing, and market uptake determine potential drug sales and long-term revenue, much like a key product in a company’s lineup that can drive growth or face competition if exclusivity ends.
A form of heart muscle disease caused when the blood protein transthyretin misfolds and deposits as sticky plaques in the heart, making the muscle stiff and less able to pump. Think of it as lint building up inside a sponge, reducing its ability to absorb and squeeze. Investors care because diagnosis rates, approved treatments, and long-term care needs drive sizable markets, regulatory milestones, and revenue potential for drugmakers and medical device companies.
all-cause mortalitymedical
All-cause mortality is the total number of deaths from any cause within a defined group over a specific time period. For investors, it is a broad safety and outcome measure used in clinical trials and public-health studies—like counting everyone who leaves a club for any reason—because higher or lower all-cause mortality can influence regulatory decisions, product reputation, long-term liability and market value.
cardiovascular-related hospitalizationsmedical
Hospital admissions caused by heart and blood vessel conditions, such as heart attacks, heart failure, strokes, or severe arrhythmias. Investors watch these figures because they measure the real-world impact of drugs, devices or public health trends on patient health and healthcare costs—think of them as a company’s performance report card for preventing serious heart problems, which can affect treatment demand, litigation risk and reimbursement.
placebomedical
A placebo is an inactive pill, injection or procedure that looks and feels like the real treatment but contains no therapeutic ingredient, often called a sugar pill. Investors care because comparing a drug to a placebo reveals whether observed benefits come from the medicine itself or from expectation; clear superiority over placebo reduces regulatory and commercial risk, much like a blind taste test proves a new recipe really tastes better.
NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE: PFE) today announced that it has entered into settlement agreements with generic drug manufacturers Dexcel Pharma, Hikma Pharmaceuticals and Cipla Ltd, regarding lawsuits filed in the U.S. 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.
About Pfizer: Breakthroughs That Change Patients’ Lives
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.
Disclosure Notice: The information contained in this release is as of April 28, 2026. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward looking information about, among other things, Pfizer’s entry into settlement agreements with generic drug manufacturers Dexcel Pharma, Hikma Pharmaceuticals and Cipla Ltd, regarding lawsuits filed in the U.S. District Court for the District of Delaware for infringement of patents relating to VYNDAMAX; U.S. patent expiry date for VYNDAMAX; revenue expectations for VYNDAMAX; and pending patent litigation and any potential future patent litigation relating to VYNDAMAX, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding revenue contribution and projections, pricing and reimbursement, market dynamics, including demand, market size and utilization rates and growth, performance, timing and duration of exclusivity; the impact and potential impact of tariffs and pricing dynamics; risks related to our patents and other intellectual property; uncertainties regarding the outcome of pending patent litigation relating to VYNDAMAX, including a patent infringement case with Apotex Corp. in the U.S. District Court for the District of Delaware, and any potential future patent litigation relating to VYNDAMAX; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws, regulations or policy; changes in tax and other laws, regulations, rates and policies; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Pfizer’s business and prospects, adverse developments in Pfizer’s markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment, tariffs and other trade policies or economies generally; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of VYNDAMAX or VYNDAQEL; uncertainties regarding the impact of COVID-19; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
