FDA Orange Book · active-ingredient family
Rivaroxaban
Rivaroxaban is approved as 2 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:XARELTO · NDA 215859
2
Brand (NDA)
21
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · for suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XARELTORLD | JANSSEN PHARMS | NDA 215859 | AB | Dec 20, 2021 | |
| XARELTORLD×4 | JANSSEN PHARMS | NDA 022406 | AB | Oct 11, 2018 |
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RIVAROXABAN | APOTEX | ANDA 218427 | AB | Mar 02, 2026 | |
| RIVAROXABAN | INVAGEN PHARMS | ANDA 218768 | AB | Feb 20, 2026 | |
| RIVAROXABAN×3 | APOTEX | ANDA 208579 | — | Nov 14, 2025 | |
| RIVAROXABAN×4 | MSN | ANDA 208546 | AB | Oct 24, 2025 | |
| RIVAROXABAN | LUPIN | ANDA 218195 | AB | Sep 25, 2025 | |
| RIVAROXABAN×4 | REGCON HOLDINGS | ANDA 218445 | AB | Aug 11, 2025 | |
| RIVAROXABAN×4 | SCIEGEN PHARMS | ANDA 218117 | AB | Jul 31, 2025 | |
| RIVAROXABAN | ALKEM LABS LTD | ANDA 218502 | AB | Jun 26, 2025 | |
| RIVAROXABAN×3 | BRECKENRIDGE | ANDA 208220 | AB | May 15, 2025 | |
| RIVAROXABAN×3 | AIPING PHARM INC | ANDA 216995 | AB | May 14, 2025 | |
| RIVAROXABAN×4 | ALEMBIC | ANDA 210301 | AB | May 14, 2025 | |
| RIVAROXABAN×4 | ASCENT PHARMS INC | ANDA 219332 | AB | May 14, 2025 | |
| RIVAROXABAN×4 | BIOCON PHARMA | ANDA 218107 | BX | May 14, 2025 | |
| RIVAROXABAN×4 | DR REDDYS | ANDA 208534 | AB | May 14, 2025 | |
| RIVAROXABAN×3 | INVAGEN PHARMS | ANDA 208543 | — | May 14, 2025 | |
| RIVAROXABAN×4 | MACLEODS PHARMS LTD | ANDA 213114 | AB | May 14, 2025 | |
| RIVAROXABAN×3 | SUNSHINE | ANDA 213348 | AB | May 14, 2025 | |
| RIVAROXABAN | APOTEX | ANDA 217810 | AB | May 02, 2025 | |
| RIVAROXABAN×4 | AUROBINDO PHARMA LTD | ANDA 208544 | AB | Apr 10, 2025 | |
| RIVAROXABAN×4 | LUPIN | ANDA 208555 | AB | Mar 03, 2025 | |
| RIVAROXABAN×4 | TARO | ANDA 208557 | AB | Mar 03, 2025 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9539218 | Feb 17, 2034 | in 7 yr 9 mo | U-1957 |
| 9539218*PED | Aug 17, 2034 | in 8 yr 3 mo |
Rivaroxaban — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
