Xarelto Generic: When Will Generic Rivaroxaban Be Available?

Xarelto’s Road to a Generic

Xarelto has had the market to itself since the FDA approved it in July 2011 (Janssen Pharmaceuticals Inc). Its one listed patent runs to August 2034. Generic companies have challenged its patents with the FDA since July 2015.

The first generic of Xarelto is expected in March 2027.

Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch. That is about 7.5 years before the last listed patent runs out, in August 2034.

Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.

Xarelto Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Xarelto’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.

Source: FDA Orange Book, application 215859, 022406. Patent numbers open the patent on Google Patents.

Patent Challenges to Xarelto

The first patent challenge to Xarelto reached the FDA in July 2015, from 8 companies on that first day. The FDA’s list has 3 entries for Xarelto, by form and strength. The FDA has not approved a first challenger’s generic yet.

Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.

Who Is Lined Up to Make Generic Rivaroxaban

Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.

Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).

Xarelto Price: What Pharmacies Pay and What Generics Usually Do

What Medicare and Medicaid Spend on Xarelto

Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.

Xarelto Strengths and Forms

Source: FDA Orange Book, Janssen Pharmaceuticals Inc. Listed for sale today by A-S Medication Solutions, Janssen Pharmaceuticals, Inc., Cardinal Health 107, LLC and Aphena Pharma Solutions - Tennessee, LLC (FDA NDC Directory).

Xarelto NDC Codes and Packages

Each Xarelto package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.

Source: the FDA NDC Directory, current listings only. Only packages sold under Xarelto’s own FDA approval (NDA 215859, NDA 22406) are listed, never a generic. Some codes belong to companies that repackage Xarelto: it is the same medicine in a different package.

Changes to This Projection

• October 2026First generic expected March 2027 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.

Every change to the expected month is logged here with the month we saw it.