FDA Orange Book

Is there a generic for Aphexda?

Aphexda contains motixafortide acetate. 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

No. The Orange Book lists no active FDA-approved generic (ANDA) for Aphexda (motixafortide acetate). The Orange Book shows its last listed patent expires December 29, 2041 and its last listed exclusivity ends September 8, 2030.

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Aphexda products in the Orange Book

Aphexda products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
powder, subcutaneousEQ 62MG BASE/VIALMarketed (Rx)None0None

NDA 217159, held by AYRMID PHARMA LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Aphexda patents

Patents listed for Aphexda
PatentExpiresCoversUse codeNDA
12257285December 29, 2041Drug productNone217159
12268725December 29, 2041Drug productNone217159

Aphexda exclusivity

Exclusivity listed for Aphexda
CodeMeaningExpiresNDA
NCENew chemical entitySeptember 8, 2028217159
ODE-442Orphan drug exclusivitySeptember 8, 2030217159

Aphexda NDC codes

Questions

Is there a generic for Aphexda?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Aphexda (motixafortide acetate). The Orange Book shows its last listed patent expires December 29, 2041 and its last listed exclusivity ends September 8, 2030.

What is the generic name for Aphexda?

The active ingredient in Aphexda is motixafortide acetate, per the FDA Orange Book.

When does the Aphexda patent expire?

The last patent listed for Aphexda in the Orange Book expires December 29, 2041. 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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