Unibest

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.

我们能如何帮助您?

获取最新活动与法规动态洞察

直接发送到您的邮箱

在此获取行业洞察与 Unibest 动态

联系我们 →