Launching after Revatio, Adcirca became the second-to-market PDE5 inhibitor upon its approval in major markets in 2009. Inhibiting the PDE5 enzyme enhances the effect of the endogenous vasodilator, nitric oxide (NO). The extracellular vasodilator NO activates cellular guanylate cyclase, which in turn increases cyclic guanosine monophosphate (cGMP) concentrations, leading to smooth muscle cell vasorelaxation. PDE5 rapidly degrades cGMP, and by inhibiting the cGMP-specific PDE5 enzyme, Adcirca inhibits the degradation of cGMP, which enhances NO-induced vasodilation (Barnett and Machado, 2006).
Adcirca (tadalafil; Eli Lilly/United Therapeutics/Nippon Shinyaku) now faces generic competition across the US and five major EU markets (France, Germany, Italy, Spain, and the UK). While Adcirca’s historical sales have exceeded the first-to-market phosphodiesterase 5 (PDE5) inhibitor Revatio (sildenafil; Pfizer), generic competition in the US from 2018 will significantly erode Adcirca’s sales. Conversely, continued uptake of PDE5 inhibitors in combination with endothelin receptor antagonists (ERAs) based on the AMBITION trial will act as an opposing force, offsetting some of the losses.
LIST OF FIGURES 8 Figure 1: Adcirca for pulmonary hypertension – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of Adcirca for pulmonary hypertension
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of Adcirca for pulmonary hypertension
12 Figure 4: Adcirca sales for pulmonary hypertension across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
5 Table 1: Adcirca drug profile
7 Table 2: Adcirca pivotal trial data in pulmonary hypertension
13 Table 3: Adcirca sales for pulmonary hypertension across the US, Japan, and five major EU markets, by country ($m), 2016–25
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