FDA Orange Book
Generic for Nexavar
Nexavar contains sorafenib. 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 Nexavar is sorafenib. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Nexavar and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Nexavar products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 200MG BASE | Marketed (Rx) | AB | 5 | AB |
NDA 021923, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sorafenib
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 207012 | AB (A-rated, therapeutically equivalent) | September 10, 2020 | EQ 200MG BASE |
| TEVA PHARMACEUTICALS USA INC | 209567 | AB (A-rated, therapeutically equivalent) | November 12, 2020 | EQ 200MG BASE |
| DR REDDYS LABORATORIES LTD | 216073 | AB (A-rated, therapeutically equivalent) | June 7, 2022 | EQ 200MG BASE |
| YABAO PHARMACEUTICAL CO LTD BEIJING | 209050 | AB (A-rated, therapeutically equivalent) | November 9, 2022 | EQ 200MG BASE |
| TORRENT PHARMACEUTICALS LTD | 217095 | AB (A-rated, therapeutically equivalent) | April 12, 2023 | EQ 200MG BASE |
Nexavar patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8877933 | December 24, 2027 | Drug substance, Drug product | U-1624 | 021923 |
| 9737488 | September 10, 2028 | Drug product | U-2107 | 021923 |
| 9737488 | September 10, 2028 | Drug product | U-1480 | 021923 |
| 9737488 | September 10, 2028 | Drug product | U-1696 | 021923 |
Nexavar NDC codes
Questions
Is there a generic for Nexavar?
Yes. The generic name for Nexavar is sorafenib. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Nexavar?
The active ingredient in Nexavar is sorafenib, per the FDA Orange Book.
When does the Nexavar patent expire?
The last patent listed for Nexavar in the Orange Book expires September 10, 2028. 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.