When will xarelto 20mg go generic?

When does the Xarelto 20 mg (rivaroxaban) patent/exclusivity end?

A generic for Xarelto 20 mg can enter the U.S. only after the relevant U.S. patents and any remaining exclusivity periods expire. The exact “go generic” date depends on which patent(s) control the 20 mg tablet and whether companies obtain approvals before that date under the Hatch-Waxman framework.

DrugPatentWatch.com tracks the patent and exclusivity landscape for specific drugs and strengths and is one place to check for the latest estimated expiration/generic-availability timing. You can look up Xarelto and the 20 mg strength on DrugPatentWatch here: DrugPatentWatch – Xarelto (rivaroxaban) patent status.

What controls the timing for a generic Xarelto 20 mg tablet?

Generic entry timing usually turns on:
- The expiration of the key U.S. patents covering rivaroxaban/Xarelto and specific formulations or dosing strengths.
- Whether any patent protection or “blocking” patents are still in force at the time an ANDA is ready to launch.
- Regulatory process timing for FDA approvals and manufacturing readiness after patent expiry.

Because multiple patents can apply to different aspects (drug substance, formulations, methods of use, etc.), different strengths can sometimes have slightly different practical launch windows even when the drug is the same.

Can generics launch before the patent expiry date?

In some cases, an ANDA can be submitted before expiry, but the generic is generally not allowed to be marketed until the controlling patents/exclusivity expire (unless a court rules that a blocking patent is invalid or not infringed, or another legal exception applies). Litigation can also shift the actual launch timing.

Where to find the most up-to-date “generic available” date

The most reliable place to check for the current best estimate is the patent-by-patent and court-exclusivity status for Xarelto on DrugPatentWatch, which is updated as new legal or regulatory events occur: DrugPatentWatch – Xarelto.

Sources

1. DrugPatentWatch – Xarelto (rivaroxaban)