Key result
Generic rivaroxaban exerts identical in vitro anticoagulant effects to branded versions across standard coagulation assays.
Why the study?
Generic formulations of rivaroxaban are marketed for interchangeable use with branded equivalents, but no published studies have directly compared their in vitro anticoagulant effects.
Do generic rivaroxaban formulations exert an identical in vitro anticoagulant effect compared to branded rivaroxaban in normal plasma?
Do generic rivaroxaban formulations exert an identical in vitro anticoagulant effect compared to branded rivaroxaban in normal plasma?
Branded and generic rivaroxaban formulations demonstrate identical in vitro anticoagulant effects, supporting their clinical interchangeability.
Identical in vitro effects support further study; leaves open clinical equivalence of generic rivaroxaban.
BACKGROUND: Several generic formulations of rivaroxaban were recently marketed to be used interchangeably with their branded equivalent. However, there have been no previously published studies that directly compared the in vitro anticoagulant effect of branded vs. generic rivaroxaban. The aim of this in vitro study was to compare the effects of three raw rivaroxaban materials, obtained from the branded (Xarelto®) and two generic (Rivarolto® and Rivaroxaban Sandoz®) rivaroxaban formulations on an array of coagulation assays. METHODS: A pool of normal plasma was spiked with several concentrations of the three rivaroxaban (range 50-750 ng/ml). The concentrations were assessed with a rivaroxaban calibrated anti-Xa assay and confirmed by ultra-high-performance liquid chromatography-mass spectrometry coupled with tandem mass spectrometry (UHPLC-MS/MS). The following assays were performed: Prothrombin time (PT), activated Partial Thromboplastin time (aPTT), Diluted Russell's Viper Venom Test (dRVVT), Thrombin time (TT), Clauss Fibrinogen, Factor VII, VIII and IX assays, and thromboelastography. RESULTS: The results obtained by the three rivaroxaban at similar concentrations were comparable. Increasing concentrations of the three rivaroxaban showed a strong positive correlation with the PT, aPTT and dRVVT assays (r > 0.95, p < 0.01 for all), and a strong negative correlation with the Factors assays (r < -0.95, p < 0.01 for all). TT and Clauss Fibrinogen were not affected by rivaroxaban. No significant difference was identified in the mean assays' results obtained by the three rivaroxaban. CONCLUSION: This study showed that the branded and generic rivaroxaban exert an identical in vitro anticoagulant effect across a wide range of concentrations.
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Mangion et al. (2024) studied this question. Generic rivaroxaban (Rivarolto® and Rivaroxaban Sandoz®) vs. Branded rivaroxaban (Xarelto®) was evaluated on In vitro anticoagulant effect on coagulation assays. Generic rivaroxaban formulations exerted an identical in vitro anticoagulant effect to branded rivaroxaban, showing strong correlations with PT, aPTT, and dRVVT assays (r > 0.95, p < 0.01).
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