FDA Orange Book
Is there a generic for Aveed?
Aveed contains testosterone undecanoate. 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 Aveed (testosterone undecanoate). The Orange Book shows its last listed patent expires May 8, 2027.
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Aveed products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intramuscular | 750MG/3ML (250MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 022219, held by ENDO OPERATIONS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Aveed patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7718640 | March 14, 2027 | Drug product | None | 022219 |
| 8338395 | May 8, 2027 | Method of use | U-1500 | 022219 |
Aveed NDC codes
Questions
Is there a generic for Aveed?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Aveed (testosterone undecanoate). The Orange Book shows its last listed patent expires May 8, 2027.
What is the generic name for Aveed?
The active ingredient in Aveed is testosterone undecanoate, per the FDA Orange Book.
When does the Aveed patent expire?
The last patent listed for Aveed in the Orange Book expires May 8, 2027. 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.
More on Aveed and Testosterone Undecanoate
- What is Aveed used for?FDA label uses
- Is Aveed a controlled substance?Schedule III
- Is Testosterone Undecanoate a controlled substance?Schedule III
- Generic for JatenzoFDA Orange Book
- Generic for KyzatrexFDA Orange Book
- Generic for TlandoFDA Orange Book
- Androgens listFDA drug class
- NDC 67979-511Aveed NDC record
- Schedule III drugs listDEA schedule