Pfizer settles with three Vyndamax generic challengers mid-trial, extends exclusivity, presumably through pay-for-delay

Context: In August 2023, Pfizer and its co-plaintiffs sued several generic pharmaceutical companies in the United States District Court for the District of Delaware for filing Abbreviated New Drug Applications (ANDAs) to market generic versions of Vyndamax (tafamidis) 61 mg capsules before the expiration of three asserted patents: U.S. Patent No. 7,214,695 (“Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding”), U.S. Patent No. 7,214,696 (“Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding”), and U.S. Patent No. 9,770,441 (“Crystalline solid forms of  6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole”). The case was scheduled for a five-day bench trial before Judge Gregory B. Williams, which began on April 27, 2026.

What’s new: Pfizer has filed stipulations to dismiss its claims against Dexcel (April 24, 2026), Cipla (April 25, 2026), and Hikma (April 28, 2026) without prejudice and with costs and fees to be paid by each party. Pfizer also issued a press release about the settlements. The bench trial lasting one day indicated that the settlements significantly reduced or obviated the disputes in the middle of the trial. Pfizer separately confirmed that a related case against Apotex is still ongoing.

Direct impact: The settlements remove three major generic challengers and, according to Pfizer, extend the effective U.S. patent expiry date for Vyndamax to June 1, 2031, subject to the outcome of remaining litigation, including the pending Apotex case. Pfizer also said it now expects Vyndamax revenues to remain relatively stable from 2028 until mid-2031.

Wider ramifications: Settlements of Hatch-Waxman patent disputes that delay generic drug entry can attract attention because they can amount to a “pay-for-delay” or reverse-payment deal, even if the payment is not public money. If there were a transfer of value or a scheduling of launch dates, antitrust authorities might be interested, but priorities can change. However, this type of agreement is prevalent because it removes risk for both the brand and generic company.