FDA Orange Book
Is there a generic for Invega Sustenna?
Invega Sustenna 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 Invega Sustenna (paliperidone palmitate). The Orange Book shows its last listed patent expires January 26, 2031.
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Invega Sustenna 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 | 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 022264, held by JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Invega Sustenna patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9439906 | January 26, 2031 | Method of use | U-2758 | 022264 |
| 9439906 | January 26, 2031 | Method of use | U-2757 | 022264 |
Invega Sustenna NDC codes
Questions
Is there a generic for Invega Sustenna?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Invega Sustenna (paliperidone palmitate). The Orange Book shows its last listed patent expires January 26, 2031.
What is the generic name for Invega Sustenna?
The active ingredient in Invega Sustenna is paliperidone palmitate, per the FDA Orange Book.
When does the Invega Sustenna patent expire?
The last patent listed for Invega Sustenna in the Orange Book expires January 26, 2031. 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.
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