Pfizer is currently attempting to fend off generics for Vyndamax and Vyndaqel. Both drugs indicated for treatment of cardiomyopathy caused by transthyretin amyloidosis. Both contain the same active ingredient, tafamidis, but one is a salt form. Vyndamax contains the free acid form of tafamidis, whereas Vyndaqel contains the meglumine salt of tafamidis. Pfizer has patents for both drugs, expiring as early as 2025 and as late as 2035. How long can Pfizer keep out generics?
Read MoreSoleno Therapeutics is anxiously awaiting FDA approval on its extended-release formulation of diazoxide choline (DCCR), which is indicated for treating Prader-Willis syndrome (PWS). Soleno’s drug has already received breakthroughdesignation status from FDA, as well as orphan drug designation. Together, that suggests that if Soleno’s drug is approved this month, it will receive FDA-approved exclusivity for seven years. Yet, after that, which patents does Soleno have that it can use to delay entry of generics?
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