FDA Orange Book
Is there a generic for Invega Hafyera?
Invega Hafyera 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 Hafyera (paliperidone palmitate). The Orange Book shows its last listed patent expires November 24, 2041.
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Invega Hafyera products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, extended release, intramuscular | 1.092GM/3.5ML (312MG/ML) | Marketed (Rx) | None | 0 | None |
| suspension, extended release, intramuscular | 1.560GM/5ML (312MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 207946, 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 Hafyera patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11324751 | May 7, 2041 | Method of use | U-3359 | 207946 |
| 11304951 | May 7, 2041 | Method of use | U-3349 | 207946 |
| 12208100 | May 7, 2041 | Method of use | U-3359 | 207946 |
| 12208100 | May 7, 2041 | Method of use | U-4110 | 207946 |
| 11666697 | November 24, 2041 | Method of use | U-3626 | 207946 |
Invega Hafyera NDC codes
Questions
Is there a generic for Invega Hafyera?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Invega Hafyera (paliperidone palmitate). The Orange Book shows its last listed patent expires November 24, 2041.
What is the generic name for Invega Hafyera?
The active ingredient in Invega Hafyera is paliperidone palmitate, per the FDA Orange Book.
When does the Invega Hafyera patent expire?
The last patent listed for Invega Hafyera in the Orange Book expires November 24, 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.