Pfizer extends VYNDAMAX patent protection to 2031 through settlements

Pfizer Inc. (NYSE: PFE) reached settlement agreements with three generic drug manufacturers regarding patent infringement lawsuits for VYNDAMAX, extending the drug's effective U.S. patent expiry date to June 1, 2031.

The pharmaceutical company settled with Dexcel Pharma, Hikma Pharmaceuticals and Cipla Ltd over lawsuits filed in the U.S. District Court for the District of Delaware. The settlements concern patents for VYNDAMAX (tafamidis), which treats cardiomyopathy transthyretin-mediated amyloidosis.

Pfizer had previously expected a significant decline in U.S. revenues for VYNDAMAX beginning in 2029 when patents were set to expire. The company now anticipates revenues will remain relatively stable from 2028 through mid-2031, subject to the outcome of other litigation.

VYNDAMAX holds 75% of prescription volume within the ATTR-CM market. The drug is approved as the only once-daily capsule for ATTR-CM with demonstrated reductions in all-cause mortality and cardiovascular-related hospitalizations.

As of December 31, 2025, Pfizer discontinued the supply of VYNDAQEL in the United States, leaving VYNDAMAX as the available option for eligible patients. The company cited consultation with clinical experts and patient advocates who supported the single-capsule, once-daily format for patient convenience.

The settlement extends patent protection despite ongoing litigation, including a patent infringement case with Apotex Corp. in the same Delaware court. The final patent expiry date remains subject to the outcome of these other legal proceedings.

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