FDA Orange Book
Is there a generic for Vivitrol?
Vivitrol contains naltrexone. 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 Vivitrol (naltrexone). The Orange Book shows its last listed patent expires October 15, 2029.
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Vivitrol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, extended release, intramuscular | 380MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 021897, held by ALKERMES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vivitrol patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7919499 | October 15, 2029 | Method of use | U-1124 | 021897 |
| 7919499 | October 15, 2029 | Method of use | U-1123 | 021897 |
Questions
Is there a generic for Vivitrol?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vivitrol (naltrexone). The Orange Book shows its last listed patent expires October 15, 2029.
What is the generic name for Vivitrol?
The active ingredient in Vivitrol is naltrexone, per the FDA Orange Book.
When does the Vivitrol patent expire?
The last patent listed for Vivitrol in the Orange Book expires October 15, 2029. 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.