FDA Orange Book
Is there a generic for Zimhi?
Zimhi contains naloxone. 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 Zimhi (naloxone). The Orange Book shows its last listed patent expires June 14, 2041.
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Zimhi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intramuscular, subcutaneous | 5MG/0.5ML (5MG/0.5ML) | Marketed (Rx) | None | 0 | None |
NDA 212854, held by ZMI PHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zimhi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11027072 | May 24, 2039 | Drug product | None | 212854 |
| 11571518 | June 14, 2041 | Drug product | U-3515 | 212854 |
| 11571518 | June 14, 2041 | Drug product | U-3516 | 212854 |
| 11571518 | June 14, 2041 | Drug product | U-3517 | 212854 |
Zimhi NDC codes
Questions
Is there a generic for Zimhi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zimhi (naloxone). The Orange Book shows its last listed patent expires June 14, 2041.
What is the generic name for Zimhi?
The active ingredient in Zimhi is naloxone, per the FDA Orange Book.
When does the Zimhi patent expire?
The last patent listed for Zimhi in the Orange Book expires June 14, 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.