FDA Orange Book
Generic for Xofluza
Xofluza contains baloxavir marboxil. 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 Xofluza is baloxavir marboxil. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 6 Xofluza products the Orange Book lists.
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Xofluza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | 2MG/ML | Marketed (Rx) | None | 0 | None |
| for suspension, oral | 30MG/PACKET | Marketed (Rx) | None | 0 | None |
| for suspension, oral | 40MG/PACKET | Marketed (Rx) | None | 0 | None |
| tablet, oral | 20MG | Discontinued | None | 0 | None |
| tablet, oral | 40MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 80MG | Marketed (Rx) | AB | 1 | AB |
NDA 214410, 210854, held by GENENTECH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic baloxavir marboxil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NORWICH PHARMACEUTICALS INC | 217449 | AB (A-rated, therapeutically equivalent) | June 17, 2026 | 40MG, 80MG |
Xofluza patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9815835 | June 14, 2030 | Drug product | None | 214410 |
| 8927710 | May 5, 2031 | Drug product | None | 214410 |
| 8987441 | October 24, 2032 | Drug substance, Drug product | None | 214410 |
| 10633397 | April 27, 2036 | Method of use | U-2816 | 214410 |
| 10633397 | April 27, 2036 | Method of use | U-3000 | 214410 |
| 10392406 | April 27, 2036 | Drug substance | None | 214410 |
| 11306106 | August 9, 2037 | Method of use | U-2816 | 214410 |
| 11306106 | August 9, 2037 | Method of use | U-3000 | 214410 |
| 10759814 | August 9, 2037 | Drug substance, Drug product | None | 214410 |
| 11261198 | September 25, 2038 | Drug product | None | 214410 |
| 12064438 | October 9, 2039 | Drug product | None | 210854 |
| 11925648 | April 21, 2041 | Drug product | None | 214410 |
Xofluza exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-187 | Miscellaneous | December 19, 2027 | 214410 |
Xofluza NDC codes
Questions
Is there a generic for Xofluza?
Yes. The generic name for Xofluza is baloxavir marboxil. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 6 Xofluza products the Orange Book lists.
What is the generic name for Xofluza?
The active ingredient in Xofluza is baloxavir marboxil, per the FDA Orange Book.
When does the Xofluza patent expire?
The last patent listed for Xofluza in the Orange Book expires April 21, 2041. 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.