FDA — authorised 4 November 2011
- Application: NDA202439
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: XARELTO
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Xarelto in United States
FDA authorised Xarelto on 4 November 2011
Marketing authorisations
FDA — authorised 27 October 2017
- Application: NDA022406
- Marketing authorisation holder: JANSSEN PHARMS
- Indication: Efficacy
- Status: approved
FDA — authorised 20 December 2021
- Application: NDA215859
- Marketing authorisation holder: JANSSEN PHARMS
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 2 May 2025
- Application: ANDA217810
- Marketing authorisation holder: APOTEX
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 2025
- Application: ANDA216995
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 2025
- Application: ANDA210301
- Marketing authorisation holder: ALEMBIC
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 2025
- Application: ANDA213114
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 2025
- Application: ANDA219332
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 May 2025
- Application: ANDA208220
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 June 2025
- Application: ANDA218502
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
FDA — authorised 31 July 2025
- Application: ANDA218117
- Marketing authorisation holder: SCIEGEN PHARMS
- Status: approved
FDA — authorised 11 August 2025
- Application: ANDA218445
- Marketing authorisation holder: REGCON HOLDINGS
- Status: approved
FDA — authorised 25 September 2025
- Application: ANDA218195
- Marketing authorisation holder: LUPIN
- Local brand name: RIVAROXABAN
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 14 November 2025
- Application: ANDA208579
- Marketing authorisation holder: APOTEX
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
The FDA approved the application (ANDA208579) submitted by APOTEX for RIVAROXABAN (Xarelto) on 14 November 2025. This approval allows APOTEX to market RIVAROXABAN (Xarelto) in the United States. The indication approved for RIVAROXABAN (Xarelto) is for oral tablet administration.
FDA — authorised 20 February 2026
- Application: ANDA218768
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: RIVAROXABAN
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Xarelto (Rivaroxaban) for oral tablet use on 20 February 2026. Invagen Pharms, the marketing authorisation holder, submitted application number ANDA218768. The approval was granted under the standard expedited pathway. Xarelto is indicated for use in the United States, but the specific indication is not specified in the provided information.
Xarelto in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Xarelto approved in United States?
Yes. FDA authorised it on 4 November 2011; FDA authorised it on 27 October 2017; FDA authorised it on 20 December 2021.
Who is the marketing authorisation holder for Xarelto in United States?
JANSSEN PHARMS holds the US marketing authorisation.