Rivaroxaban

XARELTO®

Cardiovascular disease

How many generic entrants will we see? Will any litigation settlements be disclosed, and how quickly will prices erode for this top-selling drug?

About XARELTO®

  1. Patented by Bayer Healthcare AG, marketed by Janssen in the United States
  2. Factor XA inhibitor used to treat and prevent blood clots, which may lower the risk of stroke, deep vein thrombosis (DVT), pulmonary embolism (PE) and similar conditions

Approvals

  1. First E.U. approval date: September 30, 2008
  2. First U.S. approval date: July 1, 2011
  3. Constraint Date Forecast – 2023 (E.U. Top 5) and 2024 (U.S., Japan)

About XARELTO® in the market

  1. Seventeen ANDA filings, with three tentative approvals
    • Eight ANDAs filed on the first day possible and may share eligibility for the 180-day generic drug exclusivity
    • Four ANDAs for the 2.5 mg tablet filed on the same day and may share eligibility for the 180-day generic drug exclusivity for that strength
  2. 2020 sales:
    • Global sales: $11.6 billion
    • Highest U.S. sales of all LOE products reviewed: $6.5 billion

U.S. market share

Source: Clarivate Generics Intelligence

Current pricing trends across the United States, European Union top 5 and Japan (considers average pack size, ex manufacturer list price)

Source: Cortellis Generics Intelligence

About Bayer Healthcare AG

  1. Products for cardiology, oncology, ophthalmology, hematology, women’s health and infectious diseases therapeutic areas
  2. Cardiology portfolio: XARELTO® (rivaroxaban), ADALAT® (nifedipine), ADEMPAS® (riociguat) and VERQUVO® (vericiguat)
  3. Riociguat ($303.5 million worldwide in 2020) currently in litigation in the United States and losing exclusivity in 2028 in the European Union top five and Japan
  4. Vericiguat under development with Merck & Co. and just approved in the United States in January 2021

Patient impact

Given the many indications treated with Xarelto, the impact of generic options could be significant, providing access to this treatment for a larger proportion of patients.

For peripheral artery disease, the launch of branded agents might encourage companies to adopt an aggressive approach to increasing awareness of the disease among patients and physicians, leading to earlier diagnosis and better outcomes.

~13 million
people have peripheral arterial disease in the key markets

Based on Cortellis data, API is excessively available from manufacturers in Asia.

Source: Cortellis Generics Intelligence

Source: Cortellis Generics Intelligence

Data current as of April 14, 2021

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