FDA Orange Book · active-ingredient family
Febuxostat
Febuxostat: 1 brand, 15 generics; first approved Feb 13, 2009; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 15 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
15
Listed patents
2
Next patent expiry
Sep 08, 2031
in 5 yr 2 mo
Brand (NDA) products
Originator applications
- ULORICRLDTAKEDA PHARMS USANDA 02185620092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB
Generic (ANDA) products (15)
Abbreviated applications
- FEBUXOSTATLUPINANDA 20540620242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — - FEBUXOSTATTORRENTANDA 21183720232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — - FEBUXOSTATAUROBINDO PHARMA LTDANDA 21074120232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - FEBUXOSTATMACLEODS PHARMS LTDANDA 20729320232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - FEBUXOSTATZYDUS LIFESCIENCESANDA 20544320232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - FEBUXOSTATPRINSTON INCANDA 20626620222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - FEBUXOSTATALKEM LABS LTDANDA 21292420212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - FEBUXOSTATDR REDDYSANDA 20537420202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - FEBUXOSTATSUNSHINEANDA 21306920202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - FEBUXOSTATMSNANDA 21046120192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - FEBUXOSTATREGCON HOLDINGSANDA 21029220192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - FEBUXOSTATHIKMAANDA 20541420192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - FEBUXOSTATALEMBICANDA 20542120192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB - FEBUXOSTATPHARMOBEDIENTANDA 20538520192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — 80MG TABLET ORAL Discontinued — - FEBUXOSTATSUN PHARMANDA 20546720192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9107912 | in 5 yr 2 mo | U-1346 | |
| 8372872 | in 5 yr 2 mo | U-1346 |
Approval history
FDA approval span
First approval
17 yr 9 mo ago
Most recent approval
2 yr 7 mo ago
Approvals span 2009–2024 across 16 FDA applications.
Brand (NDA) 16%
Generic (ANDA) 1594%
Febuxostat: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
