FDA Orange Book

Generic for Auryxia

Auryxia contains ferric citrate. 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 Auryxia is ferric citrate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Auryxia products in the Orange Book

Auryxia products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oralEQ 210MG IRONMarketed (Rx)AB1AB

NDA 205874, held by KERYX BIOPHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic ferric citrate

Approved generic versions of Auryxia
CompanyANDATE codeApprovedStrengths
TEVA PHARMACEUTICALS USA INC212563AB (A-rated, therapeutically equivalent)March 11, 2026EQ 210MG IRON

Auryxia patents

Patents listed for Auryxia
PatentExpiresCoversUse codeNDA
8093423April 21, 2026Method of useU-1577205874
10300039July 21, 2030Method of useU-2549205874
9387191July 21, 2030Drug productNone205874

Auryxia NDC codes

Questions

Is there a generic for Auryxia?

Yes. The generic name for Auryxia is ferric citrate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Auryxia?

The active ingredient in Auryxia is ferric citrate, per the FDA Orange Book.

When does the Auryxia patent expire?

The last patent listed for Auryxia in the Orange Book expires July 21, 2030. 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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