FDA Orange Book
Generic for Xarelto
Xarelto contains rivaroxaban. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Xarelto is rivaroxaban. 20 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
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Xarelto products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | 1MG/ML | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 10MG | Marketed (Rx) | AB | 16 | AB, BX |
| tablet, oral | 15MG | Marketed (Rx) | AB | 16 | AB, BX |
| tablet, oral | 2.5MG | Marketed (Rx) | AB | 16 | AB, BX |
| tablet, oral | 20MG | Marketed (Rx) | AB | 16 | AB, BX |
NDA 215859, 022406, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic rivaroxaban
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 217810 | AB (A-rated, therapeutically equivalent) | May 2, 2025 | 2.5MG |
| AIPING PHARMACEUTICAL INC | 216995 | AB (A-rated, therapeutically equivalent) | May 14, 2025 | 10MG, 15MG, 20MG |
| ALEMBIC PHARMACEUTICALS LTD | 210301 | AB (A-rated, therapeutically equivalent) | May 14, 2025 | 10MG, 15MG, 2.5MG, 20MG |
| ASCENT PHARMACEUTICALS INC | 219332 | AB (A-rated, therapeutically equivalent) | May 14, 2025 | 10MG, 15MG, 2.5MG, 20MG |
| BIOCON PHARMA LTD | 218107 | BX (B-rated, not considered equivalent) | May 14, 2025 | 10MG, 15MG, 2.5MG, 20MG |
| DR REDDYS LABORATORIES LTD | 208534 | AB (A-rated, therapeutically equivalent) | May 14, 2025 | 10MG, 15MG, 2.5MG, 20MG |
| LUPIN LTD | 208555 | AB (A-rated, therapeutically equivalent) | May 14, 2025 | 10MG, 15MG, 2.5MG, 20MG |
| MACLEODS PHARMACEUTICALS LTD | 213114 | AB (A-rated, therapeutically equivalent) | May 14, 2025 | 10MG, 15MG, 2.5MG, 20MG |
| SUNSHINE LAKE PHARMA CO LTD | 213348 | AB (A-rated, therapeutically equivalent) | May 14, 2025 | 10MG, 15MG, 20MG |
| AUROBINDO PHARMA LTD | 208544 | AB (A-rated, therapeutically equivalent) | May 15, 2025 | 10MG, 15MG, 2.5MG, 20MG |
| BRECKENRIDGE PHARMACEUTICAL INC | 208220 | AB (A-rated, therapeutically equivalent) | May 15, 2025 | 10MG, 15MG, 20MG |
| ALKEM LABORATORIES LTD | 218502 | AB (A-rated, therapeutically equivalent) | June 26, 2025 | 1MG/ML |
| SCIEGEN PHARMACEUTICALS INC | 218117 | AB (A-rated, therapeutically equivalent) | July 31, 2025 | 10MG, 15MG, 2.5MG, 20MG |
| REGCON HOLDINGS LLC | 218445 | AB (A-rated, therapeutically equivalent) | August 11, 2025 | 10MG, 15MG, 2.5MG, 20MG |
| LUPIN LTD | 218195 | AB (A-rated, therapeutically equivalent) | September 25, 2025 | 1MG/ML |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 208557 | AB (A-rated, therapeutically equivalent) | October 7, 2025 | 10MG, 15MG, 2.5MG, 20MG |
| MSN LABORATORIES PRIVATE LTD | 208546 | AB (A-rated, therapeutically equivalent) | October 24, 2025 | 2.5MG |
| INVAGEN PHARMACEUTICALS INC | 218768 | AB (A-rated, therapeutically equivalent) | February 20, 2026 | 2.5MG |
| MICRO LABS LTD | 208334 | AB (A-rated, therapeutically equivalent) | June 30, 2026 | 10MG, 15MG, 2.5MG, 20MG |
| MANKIND PHARMA LTD | 220874 | AB (A-rated, therapeutically equivalent) | July 1, 2026 | 10MG, 15MG, 2.5MG, 20MG |
| EPIC PHARMA LLC | 216255 | AB (A-rated, therapeutically equivalent) | August 19, 2026 | 10MG, 15MG, 2.5MG, 20MG |
Xarelto patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9539218 | February 17, 2034 | Method of use | U-1957 | 022406 |
| 9539218 | February 17, 2034 | Method of use | U-2641 | 022406 |
| 9539218 | February 17, 2034 | Method of use | U-2143 | 022406 |
| 9539218 | February 17, 2034 | Method of use | U-3288 | 022406 |
| 9539218 | February 17, 2034 | Method of use | U-1953 | 022406 |
| 9539218 | February 17, 2034 | Method of use | U-3289 | 022406 |
| 9539218 | February 17, 2034 | Method of use | U-1955 | 022406 |
| 9539218 | February 17, 2034 | Method of use | U-1954 | 022406 |
| 9539218 | February 17, 2034 | Method of use | U-3285 | 022406 |
| 9539218*PED | August 17, 2034 | Method of use | None | 022406 |
Xarelto NDC codes
Questions
Is there a generic for Xarelto?
Yes. The generic name for Xarelto is rivaroxaban. 20 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
What is the generic name for Xarelto?
The active ingredient in Xarelto is rivaroxaban, per the FDA Orange Book.
When does the Xarelto patent expire?
The last patent listed for Xarelto in the Orange Book expires August 17, 2034. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.