FDA Orange Book · active-ingredient family
Cefixime
Cefixime: 4 brands, 13 generics; first approved Apr 28, 1989; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 13 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
4
Generics (ANDA)
13
Listed patents
1
Next patent expiry
Dec 14, 2028
in 2 yr 4 mo
Brand (NDA) products
Originator applications
- LUPIN LTDNDA 2020912013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML FOR SUSPENSION ORAL Rx AB - LUPIN LTDNDA 2031952012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG CAPSULE ORAL Rx AB - SUPRAXRLDLEDERLENDA 0506221989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML FOR SUSPENSION ORAL Discontinued — - SUPRAXRLDLEDERLENDA 05062119892 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — 400MG TABLET ORAL Discontinued —
Generic (ANDA) products (13)
Abbreviated applications
- CEFIXIMEFDC LTDANDA 21869120262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML FOR SUSPENSION ORAL Rx AB 200MG/5ML FOR SUSPENSION ORAL Rx AB - CEFIXIMEAUROBINDO PHARMA LTDANDA 2176072026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG CAPSULE ORAL Rx AB - CEFIXIMERSFDC LTDANDA 2063582024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Rx — - CEFIXIMEALKEM LABS LTDANDA 21177520212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML FOR SUSPENSION ORAL Rx AB 200MG/5ML FOR SUSPENSION ORAL Rx AB - CEFIXIMEALKEM LABS LTDANDA 2105742018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG CAPSULE ORAL Rx AB - CEFIXIMECHARTWELL RXANDA 20614420172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML FOR SUSPENSION ORAL Discontinued — 200MG/5ML FOR SUSPENSION ORAL Discontinued — - CEFIXIMEAJENAT PHARMSANDA 20693820172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML FOR SUSPENSION ORAL Rx AB 200MG/5ML FOR SUSPENSION ORAL Rx AB - CEFIXIMEAJENAT PHARMSANDA 2069392017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/5ML FOR SUSPENSION ORAL Rx AB - CEFIXIMEAUROBINDO PHARMA LTDANDA 20483520152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML FOR SUSPENSION ORAL Rx AB 200MG/5ML FOR SUSPENSION ORAL Rx AB - LUPIN LTDANDA 06538020103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, CHEWABLE ORAL Discontinued — 150MG TABLET, CHEWABLE ORAL Discontinued — 200MG TABLET, CHEWABLE ORAL Discontinued — - SUPRAXRSLUPIN PHARMSANDA 0653552007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/5ML FOR SUSPENSION ORAL Rx AB - LUPIN PHARMSANDA 0651292004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML FOR SUSPENSION ORAL Discontinued — - LUPIN PHARMSANDA 0651302004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9233112 | in 2 yr 4 mo | ProductU-1676 |
Approval history
FDA approval span
First approval
37 yr 10 mo ago
Most recent approval
3 mo ago
Approvals span 1989–2026 across 17 FDA applications.
Brand (NDA) 424%
Generic (ANDA) 1376%
Cefixime: 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.
