The settlements delay the entry of generic copies of Pfizer’s Vyndamax by almost three years, stabilizing sales of a drug that generated $3.8 billion in the U.S. last year.
Pfizer has reached settlements with three generic drugmakers, delaying the entry of off-patent rivals to its blockbuster heart disease drug Vyndamax until mid-2031.
Prior to the settlements, Pfizer anticipated a significant decline in U.S. Vyndamax revenues beginning in 2029 upon patent expiry. The drugmaker reported $3.8 billion in U.S. sales of Vyndamax and related products in 2025. Having settled with Dexcel Pharma, Hikma Pharmaceuticals and Cipla, Pfizer predicted that U.S. Vyndamax sales will now remain relatively stable from 2028 through mid-2031.
S&P Visible Alpha’s pre-settlement consensus was that Vyndamax U.S. sales would fall from $3.6 billion in 2028 to $1.8 billion in 2029, Leerink Partners analysts said in a Tuesday note to investors. Analysts expected the slide to continue, with the consensus being that U.S. sales of the cardiomyopathy transthyretin-mediated amyloidosis (ATTR-CM) drug would sink to $1 billion in 2030 and $600 million in 2031.
Leerink analysts said delaying the entry of generic copies will support higher cash flows for Pfizer. Yet the length of the delay may disappoint some observers, with the analysts noting that some buyside investors hoped Pfizer could defer generic competition until closer to the expiry of a polymorph patent in 2035.
With generic competitors arriving in 2031, the anticipated erosion of Vyndamax sales now falls outside of the period in which Pfizer expects its loss of exclusivity headwinds to peak. Loss of exclusivity on key products could create a $1.5 billion headwind for Pfizer this year, rising to $4.5 billion in 2027, CEO Albert Bourla said at the J.P. Morgan Healthcare Conference in January.
Maintaining Vyndamax sales beyond 2029 could help Pfizer “stabilize the revenue base through this window while supporting confidence in the sustainability of the current dividend,” BMO Capital Markets analysts said in a note to investors. Pfizer is racing to bring molecules, including obesity drug candidate MET097 and PD-1/VEGF bispecific antibody PF-08634404, to market to drive growth in the 2030s.
The settlement has implications for Pfizer’s rivals in the ATTR-CM market, which now know when their products will face competition from potentially cheaper generic copies of Vyndamax. Delaying the entry of Vyndamax generics until 2031 “represents an upside scenario” for BridgeBio Pharma’s ATTR-CM drug Attruby, Truist Securities analysts said in a note to investors.
Yet BridgeBio’s share price closed down 6.5% at $69.66 on Tuesday. Truist analysts’ positive take on the outcome reflected their assumption that Vyndamax would lose exclusivity in 2028. Some investors were hoping Pfizer could delay generic competition until 2033 or as long as 2035, William Blair analysts said in a note to investors. William Blair analysts said Attruby sales could keep growing amid generic competition.
