Pfizer withdrew European patent EP3191461B1 during a hearing with the European Patent Office. The patent covered certain crystalline solid forms of tafamidis used in Vyndaqel, which is marketed as Vyndamax in the U.S. Jefferies reported that a three-member panel found the patent inventive but raised questions regarding its novelty.
A Pfizer spokesperson confirmed that the European Patent Office revoked the ’461 tafamidis polymorph patent on Feb. 5. The development raised concerns among investors that Pfizer’s loss of patent protection could allow generic versions of tafamidis to enter the market earlier than previously expected.
Through its partnership with Bayer, BridgeBio markets the small-molecule ATTR-CM treatment Beyonttra, known as Attruby in the U.S. Following the patent withdrawal, some investors expressed concern that generic tafamidis could become available as early as 2028, potentially affecting pricing in the ATTR-CM market. These concerns emerged three years after Attruby’s launch.
Some investors have previously believed that tafamidis would maintain market exclusivity until 2035 in the U.S. The FDA Orange Book lists a patent covering crystalline solid forms of tafamidis that extends through August 2035. In Europe, however, regulatory protections differ. Pfizer stated that Vyndaqel’s ATTR-CM indication benefits from orphan drug exclusivity until February 2030. In addition, supplementary protection certificates covering the tafamidis compound last until November 2026 in most European countries.
Leerink Partners analyst Mani Foroohar, M.D., said in a recent interview with Fierce Pharma that the availability of generics to an established drug typically presents challenges for reimbursement in Europe due to comparability pricing, also known as reference pricing, which allows EU countries to benchmark costs among similar medicines.
Despite the market reaction, analysts at Jefferies and Evercore ISI said BridgeBio investors overreacted to Pfizer’s decision. In a Feb. 5 note, Evercore analysts wrote that the news does not affect baseline assumptions for Attruby, which already include generic tafamidis entry in December 2028, and stated that there is no risk of earlier generic competition for BridgeBio.
Evercore’s team described Pfizer’s move as a strategic withdrawal that did not result from a regulatory ruling and therefore set no legal precedent. They characterized the decline in BridgeBio’s share price as disconnected from underlying fundamentals.
Jefferies analyst Andrew Tsai said that Attruby is emerging as a first-line ATTR-CM treatment that may be differentiated from Vyndamax. Tsai projected peak sales for Attruby between $4 billion and $5 billion by 2034, assuming linear annual growth. Evercore analysts separately argued that revenue projections of $3 billion after 2028 in a large ATTR-CM market may prove conservative.
BridgeBio has focused on supporting Attruby’s profile through biochemical studies, clinical trial data, and real-world evidence. “We continue to focus on differentiating [Attruby] as a best-in-class, first-line stabilizer,” BridgeBio CEO Neil Kumar, Ph.D., said in a November 2025 interview.
Kumar also cited data from BridgeBio’s phase 3 clinical trial showing early separation of treatment effects compared with placebo, as well as findings from an open-label extension study in which patients switching from tafamidis to Attruby experienced greater stabilization of the transthyretin protein. He further referenced a post hoc phase 3 analysis indicating reductions in atrial-fibrillation-related hospitalizations and new-onset atrial fibrillation events among certain patients.
Kumar said that while the evidence supporting Attruby has been extensive, the company lacks a prospective head-to-head clinical trial against tafamidis, noting that such a study would require a significant size and duration that BridgeBio cannot afford.
Pfizer EU Tafamidis Patent Withdrawal and Industry Impact
Tafamidis Patent Withdrawal in the European Union
Pfizer recently made a strategic decision to withdraw a European Union patent covering certain solid forms of its tafamidis drug, which is marketed under brand names including Vyndaqel and Vyndamax. The European Patent Office revoked the patent after questioning aspects of its novelty, prompting Pfizer to withdraw the application during a hearing with the EU patent authority.
Although the patent in question was challenged, a Pfizer spokesperson confirmed that the withdrawal reflects a voluntary move rather than a regulatory defeat. The patent protected specific crystalline forms of tafamidis, which are important elements of the drug’s intellectual property.
Implications for Market Exclusivity and Competition
The withdrawal of this tafamidis patent in Europe has raised concerns among investors about the potential for earlier generic competition. In particular, rival treatments for transthyretin amyloid cardiomyopathy (ATTR‑CM), such as competitors developed by other companies, may face fewer barriers entering the market.
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