FDA Orange Book

Generic for Desferal

Desferal contains deferoxamine. 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 Desferal is deferoxamine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

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Desferal products in the Orange Book

Desferal products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, injection2GM/VIALDiscontinuedNone3AP
injectable, injection500MG/VIALMarketed (Rx)AP3AP

NDA 016267, held by MITEM PHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic deferoxamine

Approved generic versions of Desferal
CompanyANDATE codeApprovedStrengths
HOSPIRA INC076019AP (A-rated, therapeutically equivalent)March 17, 20042GM/VIAL, 500MG/VIAL
FRESENIUS KABI USA LLC078718AP (A-rated, therapeutically equivalent)September 15, 20092GM/VIAL, 500MG/VIAL
GLAND PHARMA LTD207384AP (A-rated, therapeutically equivalent)September 29, 20172GM/VIAL, 500MG/VIAL

Desferal NDC codes

Questions

Is there a generic for Desferal?

Yes. The generic name for Desferal is deferoxamine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.

What is the generic name for Desferal?

The active ingredient in Desferal is deferoxamine, per the FDA Orange Book.

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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