Revista Farmespaña Industrial - Septiembre Octubre 2026

Claves para entender las patentes y exclusividades de medicamentos ante la FDA Cuando un nuevo medicamento llega al mercado estadounidense, su protección frente a la competencia puede depender de diferentes mecanismos. Entre los más importantes se encuentran las patentes y los periodos de exclusividad regulatoria concedidos bajo la legislación administrada por la Food and Drug Administration (FDA). 8 0(G0%# "-:/5# 60%*%(# $%)$"5"$# 7"# %()$"*"# *%# *%)%$-'("*/5# 6$/*0&> )/5# &/-6%)'*/$%5# <# &/(# .$%&0%(> &'"# 5%# -%(&'/("(# &/(J0()"-%()%9# (/# 5/(# %G0'D"7%()%5?# Y'%(%(# 0(# /$';%(# *'.%$%()%9# $%56/(*%(# "# (/$-"5# *'5)'()"5# <# 60%*%(# &/-%(M"$#<#.'("7'M"$#%(#-/-%()/5#&/-67%> )"-%()%#'(*%6%(*'%()%5? 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