Dabigatran; Rivaroxaban — Competitive Intelligence Brief

Dabigatran; Rivaroxaban (Dabigatran; Rivaroxaban) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Direct oral anticoagulant (DOAC). Area: Cardiovascular.

marketed Direct oral anticoagulant (DOAC) Dabigatran: Factor IIa (thrombin); Rivaroxaban: Factor Xa Cardiovascular Small molecule

Target snapshot

Dabigatran; Rivaroxaban (Dabigatran; Rivaroxaban) — University Hospital, Grenoble. Both dabigatran and rivaroxaban are direct oral anticoagulants that inhibit key clotting factors to prevent blood clot formation.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Dabigatran; Rivaroxaban TARGET	Dabigatran; Rivaroxaban	University Hospital, Grenoble	marketed	Direct oral anticoagulant (DOAC)	Dabigatran: Factor IIa (thrombin); Rivaroxaban: Factor Xa
Pradaxa	dabigatran etexilate	Generic (originally Boehringer Ingelheim)	marketed	Direct oral anticoagulant (DOAC) — direct thrombin inhibitor	Multidrug and toxin extrusion protein 1, Multidrug and toxin extrusion protein 2, Ribosyldihydronicotinamide dehydrogenase [quinone]	2010-10-19
Rivaroxaban, dabigatran, apixaban, or edoxaban	Rivaroxaban, dabigatran, apixaban, or edoxaban	Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec	marketed	Direct oral anticoagulant (DOAC)	Factor Xa (rivaroxaban, apixaban, edoxaban) or Thrombin (dabigatran)
Rivaroxaban, Dabigatran	Rivaroxaban, Dabigatran	University Hospital, Grenoble	marketed	Direct oral anticoagulant (DOAC)	Factor Xa (rivaroxaban); Thrombin/Factor IIa (dabigatran)
Continuous DOAC therapy	Continuous DOAC therapy	Johns Hopkins University	phase 3	Direct oral anticoagulant (DOAC)	Factor Xa or Factor IIa (thrombin)
Full dose of DOAC	Full dose of DOAC	University Hospital, Brest	phase 3	Direct oral anticoagulant (DOAC)	Factor Xa or Factor IIa (thrombin)
Dabigatran and Apixaban	Dabigatran and Apixaban	University of Sao Paulo General Hospital	phase 3	Direct oral anticoagulant (DOAC)	Dabigatran: Factor IIa (thrombin); Apixaban: Factor Xa

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Direct oral anticoagulant (DOAC) class)

1. University Hospital, Grenoble · 2 drugs in this class
2. Centre Hospitalier Universitaire de Nīmes · 1 drug in this class
3. Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec · 1 drug in this class
4. Johns Hopkins University · 1 drug in this class
5. University Hospital, Brest · 1 drug in this class
6. University of Sao Paulo General Hospital · 1 drug in this class