FDA Orange Book

Generic for Suprax

Suprax contains cefixime. 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 Suprax is cefixime. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Suprax products the Orange Book lists.

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Suprax products in the Orange Book

Suprax products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, oral400MGMarketed (Rx)AB2AB
for suspension, oral100MG/5MLDiscontinuedNone4AB
for suspension, oral500MG/5MLMarketed (Rx)AB1AB
tablet, oral200MGDiscontinuedNone0None
tablet, oral400MGDiscontinuedNone1None

NDA 203195, 050622, 202091, 050621, held by LUPIN LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic cefixime

Approved generic versions of Suprax
CompanyANDATE codeApprovedStrengths
AUROBINDO PHARMA LTD204835AB (A-rated, therapeutically equivalent)April 14, 2015100MG/5ML
AJENAT PHARMACEUTICALS LLC206938AB (A-rated, therapeutically equivalent)February 6, 2017100MG/5ML
AJENAT PHARMACEUTICALS LLC206939AB (A-rated, therapeutically equivalent)February 6, 2017500MG/5ML
ALKEM LABORATORIES LTD210574AB (A-rated, therapeutically equivalent)October 9, 2018400MG
ALKEM LABORATORIES LTD211775AB (A-rated, therapeutically equivalent)February 19, 2021100MG/5ML
FDC LTD206358None (No TE code listed)December 17, 2024400MG
AUROBINDO PHARMA LTD217607AB (A-rated, therapeutically equivalent)March 23, 2026400MG
FDC LTD218691AB (A-rated, therapeutically equivalent)May 14, 2026100MG/5ML

Suprax patents

Patents listed for Suprax
PatentExpiresCoversUse codeNDA
9233112December 14, 2028Drug productU-1676202091

Suprax NDC codes

Questions

Is there a generic for Suprax?

Yes. The generic name for Suprax is cefixime. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Suprax products the Orange Book lists.

What is the generic name for Suprax?

The active ingredient in Suprax is cefixime, per the FDA Orange Book.

When does the Suprax patent expire?

The last patent listed for Suprax in the Orange Book expires December 14, 2028. 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.

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