FDA Orange Book
Is there a generic for Rezenopy?
Rezenopy 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 Rezenopy (naloxone). The Orange Book shows its last listed patent expires February 5, 2041 and its last listed exclusivity ends April 19, 2027.
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Rezenopy products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, nasal | 10MG/SPRAY | Marketed (Rx) | None | 0 | None |
NDA 215487, held by SCIENTURE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Rezenopy patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12514854 | February 5, 2041 | Method of use | U-4397 | 215487 |
| 12622903 | February 5, 2041 | Drug product | None | 215487 |
Rezenopy exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | April 19, 2027 | 215487 |
Rezenopy NDC codes
Questions
Is there a generic for Rezenopy?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rezenopy (naloxone). The Orange Book shows its last listed patent expires February 5, 2041 and its last listed exclusivity ends April 19, 2027.
What is the generic name for Rezenopy?
The active ingredient in Rezenopy is naloxone, per the FDA Orange Book.
When does the Rezenopy patent expire?
The last patent listed for Rezenopy in the Orange Book expires February 5, 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.