Pfizer Delays Vyndamax Generics, Safeguards $6.38 Billion Franchise Until 2031
Pfizer reached patent settlement agreements with Dexcel Pharma, Hikma and Cipla to extend US exclusivity for Vyndamax until 2031, delaying generic competition. The tafamidis franchise generated $6.38 billion in 2025, up 17% year-over-year, with Vyndamax now accounting for 75% of ATTR-CM prescriptions.
1. Patent Settlements Extend Vyndamax Exclusivity
Pfizer has settled patent-infringement suits with Dexcel Pharma, Hikma Pharmaceuticals and Cipla, preventing them from launching tafamidis generics in the US. These agreements push back the US patent expiry for Vyndamax to 2031, though final timing remains subject to ongoing litigation.
2. Strong 2025 Sales Performance
The tafamidis franchise, now solely Vyndamax after discontinuing the lower-dose Vyndaqel at end-2025, generated $6.38 billion in US sales last year, marking a 17% increase versus 2024. Market uptake remains robust in the cardiomyopathy transthyretin-mediated amyloidosis (ATTR-CM) segment.
3. Market Share and Product Positioning
Vyndamax accounts for approximately 75% of ATTR-CM prescription volume and is the only once-daily capsule approved in the US. ATTR-CM is a rare disease characterized by protein misfolding in the heart muscle, underscoring the franchise’s clinical importance.
4. Competitive Dynamics and Analyst Views
BridgeBio’s twice-daily pill Attruby is early in its launch but faces delayed generic entry pressures. Citi and William Blair analysts expect revenue forecasts for 2028–31 to rise materially, though they note generics will eventually enter the market.