
UB830
ProductRivaroxaban Tablet
Strength10mg, 15mg, 20mg
IndicationsPrevention of venous thromboembolism after hip or knee replacement; Treatment of deep vein thrombosis or pulmonary embolism; Stroke prevention in non-valvular atrial fibrillation
TherapeuticsCardiovascular; Blood and Blood Forming Organs
GMPUS - FDA; CN - NMPA; EU - EMA
RegistrationUnited States; China; EU; Malaysia; Singapore
ModalitiesSmall Molecule
Exclusive Summary
- Patents for rivaroxaban have expired in the US and EU (2023–2024), opening a golden window for generic market entry; dual FDA and EMA certification enables immediate access to top-tier regulated markets.
- Rivaroxaban addresses massive global patient populations—over 50 million AF patients worldwide and ~10 million annual VTE cases—with guideline-backed first-line status driving sustained demand.
- Existing registrations across the US, 27 EU countries, Malaysia, and Singapore represent a rare, multi-market regulatory asset that significantly reduces time-to-market for distribution partners.
- Generic pricing offers 60–80% savings versus branded Xarelto, making this product highly attractive to cost-sensitive payers, tenders, and distribution partners.
- All three strengths (10mg/15mg/20mg) are available, covering the full spectrum of indications from post-surgical VTE prophylaxis to AF stroke prevention, enabling one-stop procurement for buyers.
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