FDA Orange Book · active-ingredient family
Rivaroxaban
Rivaroxaban: 2 brands, 23 generics; first approved Jul 01, 2011; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 23 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
23
Listed patents
2
Next patent expiry
Feb 17, 2034
in 7 yr 8 mo
Brand (NDA) products
Originator applications
- JANSSEN PHARMSNDA 2158592021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML FOR SUSPENSION ORAL Rx AB - XARELTORLDJANSSEN PHARMSNDA 02240620184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 2.5MG TABLET ORAL Rx AB
Generic (ANDA) products (23)
Abbreviated applications
- RIVAROXABANMANKIND PHARMAANDA 22087420264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - RIVAROXABANMICRO LABSANDA 20833420264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - RIVAROXABANAPOTEXANDA 2184272026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML FOR SUSPENSION ORAL Rx AB - RIVAROXABANINVAGEN PHARMSANDA 2187682026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB - RIVAROXABANAPOTEXANDA 20857920253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — - RIVAROXABANMSNANDA 20854620254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 10MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — - RIVAROXABANLUPINANDA 2181952025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML FOR SUSPENSION ORAL Rx AB - RIVAROXABANREGCON HOLDINGSANDA 21844520254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - RIVAROXABANSCIEGEN PHARMSANDA 21811720254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - RIVAROXABANALKEM LABS LTDANDA 2185022025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML FOR SUSPENSION ORAL Rx AB - RIVAROXABANBRECKENRIDGEANDA 20822020253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - RIVAROXABANAIPING PHARM INCANDA 21699520253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - RIVAROXABANALEMBICANDA 21030120254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - RIVAROXABANASCENT PHARMS INCANDA 21933220254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - RIVAROXABANBIOCON PHARMAANDA 21810720254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx BX 10MG TABLET ORAL Rx BX 15MG TABLET ORAL Rx BX 20MG TABLET ORAL Rx BX - RIVAROXABANDR REDDYSANDA 20853420254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - RIVAROXABANINVAGEN PHARMSANDA 20854320253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 15MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — - RIVAROXABANMACLEODS PHARMS LTDANDA 21311420254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - RIVAROXABANSUNSHINEANDA 21334820253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - RIVAROXABANAPOTEXANDA 2178102025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB - RIVAROXABANAUROBINDO PHARMA LTDANDA 20854420254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - RIVAROXABANLUPINANDA 20855520254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB - RIVAROXABANTAROANDA 20855720254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB 15MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9539218 | in 7 yr 8 mo | U-1957 | |
| 9539218*PED | in 8 yr 2 mo |
Approval history
FDA approval span
First approval
15 yr 4 mo ago
Most recent approval
1 mo ago
Approvals span 2011–2026 across 25 FDA applications.
Brand (NDA) 28%
Generic (ANDA) 2392%
Rivaroxaban: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
