FDA Orange Book
Is there a generic for Erzofri?
Erzofri contains paliperidone palmitate. 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 Erzofri (paliperidone palmitate). The Orange Book shows its last listed patent expires September 24, 2039.
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Erzofri products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, extended release, intramuscular | 117MG/0.75ML (117MG/0.75ML) | Marketed (Rx) | None | 0 | None |
| suspension, extended release, intramuscular | 156MG/ML (156MG/ML) | Marketed (Rx) | None | 0 | None |
| suspension, extended release, intramuscular | 234MG/1.5ML (156MG/ML) | Marketed (Rx) | None | 0 | None |
| suspension, extended release, intramuscular | 351MG/2.25ML (156MG/ML) | Marketed (Rx) | None | 0 | None |
| suspension, extended release, intramuscular | 39MG/0.25ML (39MG/0.25ML) | Marketed (Rx) | None | 0 | None |
| suspension, extended release, intramuscular | 78MG/0.5ML (78MG/0.5ML) | Marketed (Rx) | None | 0 | None |
NDA 216352, held by LUYE INNOMIND PHARMA (SHIJIAZHUANG) CO LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Erzofri patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12128049 | October 26, 2038 | Method of use | U-3968 | 216352 |
| 12128049 | October 26, 2038 | Method of use | U-3969 | 216352 |
| 11666573 | September 24, 2039 | Method of use | U-3968 | 216352 |
| 11666573 | September 24, 2039 | Method of use | U-3969 | 216352 |
Erzofri NDC codes
Questions
Is there a generic for Erzofri?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Erzofri (paliperidone palmitate). The Orange Book shows its last listed patent expires September 24, 2039.
What is the generic name for Erzofri?
The active ingredient in Erzofri is paliperidone palmitate, per the FDA Orange Book.
When does the Erzofri patent expire?
The last patent listed for Erzofri in the Orange Book expires September 24, 2039. 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.