FDA Orange Book
Generic for Xtandi
Xtandi contains enzalutamide. 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 Xtandi is enzalutamide. 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 3 Xtandi products the Orange Book lists.
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Xtandi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 40MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 40MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 80MG | Marketed (Rx) | AB | 1 | AB |
NDA 203415, 213674, held by ASTELLAS PHARMA US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic enzalutamide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 216068 | AB (A-rated, therapeutically equivalent) | April 20, 2026 | 40MG, 80MG |
Xtandi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9126941 | May 15, 2026 | Method of use | U-2345 | 203415 |
| 9126941 | May 15, 2026 | Method of use | U-1588 | 203415 |
| 9126941 | May 15, 2026 | Method of use | U-2708 | 203415 |
| 9126941 | May 15, 2026 | Method of use | U-3763 | 203415 |
| 8183274 | August 24, 2026 | Method of use | U-1281 | 203415 |
| 8183274 | August 24, 2026 | Method of use | U-1588 | 203415 |
| 8183274 | August 24, 2026 | Method of use | U-2708 | 203415 |
| 8183274 | August 24, 2026 | Method of use | U-2345 | 203415 |
| 8183274 | August 24, 2026 | Method of use | U-3763 | 203415 |
| 7709517 | August 13, 2027 | Drug substance, Drug product | None | 203415 |
| 12502357 | September 11, 2033 | Method of use | U-4363 | 213674 |
| 12502357 | September 11, 2033 | Method of use | U-4364 | 213674 |
| 12502357 | September 11, 2033 | Method of use | U-4365 | 213674 |
| 11839689 | September 11, 2033 | Drug product | None | 213674 |
| 12447128 | September 11, 2033 | Method of use | U-4312 | 213674 |
| 12447128 | September 11, 2033 | Method of use | U-4313 | 213674 |
| 12447128 | September 11, 2033 | Method of use | U-4314 | 213674 |
| 12161628 | February 23, 2037 | Method of use | U-4101 | 203415 |
| 12161628 | February 23, 2037 | Method of use | U-4102 | 203415 |
| 12161628 | February 23, 2037 | Method of use | U-4103 | 203415 |
| 12161628 | February 23, 2037 | Method of use | U-4104 | 203415 |
Xtandi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-926 | New indication | November 17, 2026 | 203415 |
Xtandi NDC codes
Questions
Is there a generic for Xtandi?
Yes. The generic name for Xtandi is enzalutamide. 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 3 Xtandi products the Orange Book lists.
What is the generic name for Xtandi?
The active ingredient in Xtandi is enzalutamide, per the FDA Orange Book.
When does the Xtandi patent expire?
The last patent listed for Xtandi in the Orange Book expires February 23, 2037. 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.