FDA Orange Book
Generic for Bexlutry
Bexlutry contains lutetium lu-177 dotatate. 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 Bexlutry is lutetium lu-177 dotatate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Bexlutry products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 10mCi/ML | Marketed (Rx) | None | 1 | AP |
NDA 218525, held by CURIUM US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lutetium lu-177 dotatate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LANTHEUS MEDICAL IMAGING INC | 217060 | AP (A-rated, therapeutically equivalent) | September 21, 2026 | 10mCi/ML |
Bexlutry NDC codes
Questions
Is there a generic for Bexlutry?
Yes. The generic name for Bexlutry is lutetium lu-177 dotatate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Bexlutry?
The active ingredient in Bexlutry is lutetium lu-177 dotatate, 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.