rivaroxaban · Janssen Pharms · NDA 022406, 215859

Xarelto

Earliest generic entry, as listed · earliest of 5 marketed strengths

17 Aug 2034

2 of 5 marketed strengths have no unexpired patent or exclusivity listed.

Blocked by patent: US 9539218 (pediatric extension).

FDA has approved 9 generic applications (ANDAs) for Xarelto, though its earliest generic-entry date is 17 Aug 2034 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch

Listed patents · 1 unexpired

10 Orange Book listing rows for 1 patent, including 1 pediatric extension. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 9539218	use U-1953, U-1954, U-1955, U-1957, U-2143, U-2641, U-3285, U-3288, U-3289	17 Aug 2034	10 listing rows
US 9539218 listing row	use U-1953	17 Feb 2034	2 strengths · listed 7 Feb 2017
US 9539218 listing row	use U-1954	17 Feb 2034	listed 7 Feb 2017
US 9539218 listing row	use U-1955	17 Feb 2034	listed 7 Feb 2017
US 9539218 listing row	use U-1957	17 Feb 2034	listed 7 Feb 2017
US 9539218 listing row	use U-2143	17 Feb 2034	listed 7 Feb 2017
US 9539218 listing row	use U-2641	17 Feb 2034	listed 7 Feb 2017
US 9539218 listing row	use U-3285	17 Feb 2034	listed 7 Feb 2017
US 9539218 listing row	use U-3288	17 Feb 2034	listed 7 Feb 2017
US 9539218 listing row	use U-3289	17 Feb 2034	listed 7 Feb 2017
US 9539218 listing row	pediatric extension · sets the listed date	17 Aug 2034	3 strengths

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

Generic approved · ANDA 208579, Apotex · 022406-001Approved 14 Nov 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 218427, Apotex · 215859-001Approved 2 Mar 2026Detected 25 Oct 2026Historical import
Generic approved · ANDA 208557, Taro · 022406-001Approved 7 Oct 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 208546, Msn · 022406-001Approved 24 Oct 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 220874, Mankind Pharma · 022406-001Approved 1 Jul 2026Detected 25 Oct 2026Historical import
Generic approved · ANDA 216255, Epic Pharma Llc · 022406-001Approved 19 Aug 2026Detected 25 Oct 2026Historical import
Generic approved · ANDA 218768, Invagen Pharms · 022406-001Approved 20 Feb 2026Detected 25 Oct 2026Historical import
Generic approved · ANDA 218195, Lupin · 215859-001Approved 25 Sep 2025Detected 25 Oct 2026Historical import
Generic approved · ANDA 208334, Micro Labs · 022406-001Approved 30 Jun 2026Detected 25 Oct 2026Historical import

Products covered · 5

NDA · product	Form	Strength	Approved	Listed expiry
022406 · 001 · RLD	tablet, oral	10MG	1 Jul 2011	17 Aug 2034
022406 · 002 · RLD	tablet, oral	15MG	4 Nov 2011	17 Aug 2034
022406 · 003 · RLD	tablet, oral	20MG	4 Nov 2011	17 Aug 2034
022406 · 004 · RLD	tablet, oral	2.5MG	11 Oct 2018	open
215859 · 001 · RLD	for suspension, oral	1MG/ML	20 Dec 2021	open