FDA Orange Book
Is there a generic for Nubeqa?
Nubeqa contains darolutamide. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nubeqa (darolutamide). The Orange Book shows its last listed patent expires June 17, 2042 and its last listed exclusivity ends June 3, 2028.
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Nubeqa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 300MG | Marketed (Rx) | None | 0 | None |
NDA 212099, 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.
Nubeqa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9657003 | October 27, 2030 | Drug substance, Drug product | U-4209 | 212099 |
| 9657003 | October 27, 2030 | Drug substance, Drug product | U-4208 | 212099 |
| 9657003 | October 27, 2030 | Drug substance, Drug product | U-4210 | 212099 |
| 11046713 | October 27, 2030 | Drug substance | None | 212099 |
| 10711013 | October 27, 2030 | Drug substance, Drug product | None | 212099 |
| 8975254 | March 25, 2033 | Drug substance, Drug product | U-4208 | 212099 |
| 8975254 | March 25, 2033 | Drug substance, Drug product | U-4210 | 212099 |
| 8975254 | March 25, 2033 | Drug substance, Drug product | U-4209 | 212099 |
| 10835515 | January 28, 2036 | Drug product | U-4210 | 212099 |
| 10835515 | January 28, 2036 | Drug product | U-4208 | 212099 |
| 10835515 | January 28, 2036 | Drug product | U-4209 | 212099 |
| 10835515 | January 28, 2036 | Drug product | U-2605 | 212099 |
| 10010530 | January 28, 2036 | Drug substance | None | 212099 |
| 10383853 | January 28, 2036 | Drug substance | None | 212099 |
| 11168058 | February 27, 2038 | Drug substance, Drug product | None | 212099 |
| 12611397 | July 2, 2040 | Drug product | None | 212099 |
| 12329742 | June 17, 2042 | Drug product | None | 212099 |
Nubeqa exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-971 | New indication | June 3, 2028 | 212099 |
Nubeqa NDC codes
Questions
Is there a generic for Nubeqa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nubeqa (darolutamide). The Orange Book shows its last listed patent expires June 17, 2042 and its last listed exclusivity ends June 3, 2028.
What is the generic name for Nubeqa?
The active ingredient in Nubeqa is darolutamide, per the FDA Orange Book.
When does the Nubeqa patent expire?
The last patent listed for Nubeqa in the Orange Book expires June 17, 2042. 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.