When can xarelto go generic?

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Xarelto (dabigatran etexilate) – when might it become generic?

Item	What we know	Likely timeline
Patent status	The core patents protecting Xarelto in the U.S. are set to expire in the next few years (the main exclusivity patents ran through 2024–2025).	2024–2025
Regulatory pathway	A generic applicant must file an Abbreviated New Drug Application (ANDA) with the FDA, demonstrating that the new product is bioequivalent to Xarelto. Once the FDA reviews the data and finds no issues, it will grant approval.	2025–2027 (typical review time is 6–12 months after filing, but the filing itself may happen soon after patent expiry)
Current market	As of now, no generic dabigatran etexilate is listed on the U.S. market.	N/A
Potential first approval	If a company files promptly after the patent expires, the earliest FDA approval could come in late 2025.	Late 2025 (best‑case)
Typical window	Most generic drugs hit the market 1–3 years after the brand patent expires, once FDA review is completed.	2025–2028

Bottom line

Xarelto’s patents are about to expire (2024–2025).
Generic approval will depend on a company filing an ANDA and the FDA’s review.
The first generic dabigatran could be available anywhere from late 2025 to 2027, though exact timing is uncertain.

If you’re a prescriber or patient looking for a generic alternative, keep an eye on the FDA’s drug approval database or the U.S. Patent & Trademark Office (USPTO) docket for the first generic filing. The exact date will only become clear once the FDA announces approval.

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When can xarelto go generic?

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