FDA Orange Book
Generic for Uloric
Uloric contains febuxostat. 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 Uloric is febuxostat. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Uloric products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 40MG | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | 80MG | Marketed (Rx) | AB | 12 | AB |
NDA 021856, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic febuxostat
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALEMBIC PHARMACEUTICALS LTD | 205421 | AB (A-rated, therapeutically equivalent) | July 1, 2019 | 40MG, 80MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 205467 | AB (A-rated, therapeutically equivalent) | July 1, 2019 | 40MG, 80MG |
| HIKMA PHARMACEUTICALS USA INC | 205414 | AB (A-rated, therapeutically equivalent) | October 15, 2019 | 40MG, 80MG |
| MSN LABORATORIES PRIVATE LTD | 210461 | AB (A-rated, therapeutically equivalent) | December 30, 2019 | 40MG, 80MG |
| REGCON HOLDINGS LLC | 210292 | AB (A-rated, therapeutically equivalent) | December 30, 2019 | 40MG, 80MG |
| SUNSHINE LAKE PHARMA CO LTD | 213069 | AB (A-rated, therapeutically equivalent) | June 2, 2020 | 40MG, 80MG |
| DR REDDYS LABORATORIES LTD | 205374 | AB (A-rated, therapeutically equivalent) | October 22, 2020 | 40MG, 80MG |
| ALKEM LABORATORIES LTD | 212924 | AB (A-rated, therapeutically equivalent) | December 7, 2021 | 40MG, 80MG |
| PRINSTON PHARMACEUTICAL INC | 206266 | AB (A-rated, therapeutically equivalent) | March 28, 2022 | 40MG, 80MG |
| ZYDUS LIFESCIENCES LTD | 205443 | AB (A-rated, therapeutically equivalent) | January 9, 2023 | 40MG, 80MG |
| MACLEODS PHARMACEUTICALS LTD | 207293 | AB (A-rated, therapeutically equivalent) | September 28, 2023 | 40MG, 80MG |
| AUROBINDO PHARMA LTD | 210741 | AB (A-rated, therapeutically equivalent) | October 25, 2023 | 40MG, 80MG |
Uloric patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9107912 | September 8, 2031 | Method of use | U-1346 | 021856 |
| 8372872 | September 8, 2031 | Method of use | U-1346 | 021856 |
Uloric NDC codes
Questions
Is there a generic for Uloric?
Yes. The generic name for Uloric is febuxostat. 12 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 Uloric?
The active ingredient in Uloric is febuxostat, per the FDA Orange Book.
When does the Uloric patent expire?
The last patent listed for Uloric in the Orange Book expires September 8, 2031. 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.