FDA Orange Book

Generic for Forteo

Forteo contains teriparatide. 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 Forteo is teriparatide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Forteo products the Orange Book lists.

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Forteo products in the Orange Book

Forteo products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution, subcutaneous0.56MG/2.24ML (0.25MG/ML)Marketed (Rx)AP3AP
solution, subcutaneous0.75MG/3ML (0.25MG/ML)DiscontinuedNone0None

NDA 021318, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic teriparatide

Approved generic versions of Forteo
CompanyANDATE codeApprovedStrengths
APOTEX INC211097AP (A-rated, therapeutically equivalent)November 16, 20230.56MG/2.24ML (0.25MG/ML)
TEVA PHARMACEUTICALS USA INC208569AP (A-rated, therapeutically equivalent)November 16, 20230.56MG/2.24ML (0.25MG/ML)
AMPHASTAR PHARMACEUTICALS INC213641AP (A-rated, therapeutically equivalent)December 12, 20250.56MG/2.24ML (0.25MG/ML)

Forteo NDC codes

Questions

Is there a generic for Forteo?

Yes. The generic name for Forteo is teriparatide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Forteo products the Orange Book lists.

What is the generic name for Forteo?

The active ingredient in Forteo is teriparatide, 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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