Pfizer settlements push Vyndamax generic entry to 2031

Pfizer has settled patent litigation with three generic drugmakers over its ATTR-CM drug Vyndamax, extending the product's effective US patent expiry to June 1, 2031.

The company announced the agreements with Dexcel Pharma, Hikma Pharmaceuticals and Cipla on April 28. The cases were filed in federal court in Delaware. The new date remains subject to the outcome of other litigation, including a separate case with Apotex, StreetInsider reported.

Pfizer said it had previously expected a significant decline in US Vyndamax revenue beginning in 2029, when patents were due to expire. It now expects revenue to remain relatively stable from 2028 through mid-2031, BioPharma Asia reported.

Pfizer also stopped supplying its older tafamidis product, Vyndaqel, in the US at the end of 2025, saying one daily Vyndamax capsule is simpler for patients than four Vyndaqel capsules. Analysts saw a commercial motive as well: Vyndaqel faced generic competition from 2028, while Vyndamax is covered by a later patent. Jefferies argued that moving patients early would leave little Vyndaqel use for generics to capture and could slow the erosion of the franchise, Life Sciences Voice reported.

The settlements mean payers will face branded tafamidis pricing for longer. Competing branded drugs from BridgeBio and Alnylam are not substitutable generics. Generic versions would be listed in the FDA's Orange Book of approved drugs and therapeutic equivalents.