FDA Orange Book
Generic for Invega
Invega contains paliperidone. 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
Yes. The generic name for Invega is paliperidone. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Invega products the Orange Book lists.
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Invega products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 1.5MG | Discontinued | None | 10 | AB |
| tablet, extended release, oral | 12MG | Discontinued | None | 0 | None |
| tablet, extended release, oral | 3MG | Marketed (Rx) | AB | 11 | AB |
| tablet, extended release, oral | 6MG | Marketed (Rx) | AB | 11 | AB |
| tablet, extended release, oral | 9MG | Marketed (Rx) | AB | 11 | AB |
NDA 021999, 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.
Approved generic paliperidone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES LTD | 205618 | AB (A-rated, therapeutically equivalent) | April 6, 2018 | 1.5MG, 3MG, 6MG, 9MG |
| ADAPTIS PHARMA PRIVATE LTD | 204452 | AB (A-rated, therapeutically equivalent) | June 12, 2019 | 1.5MG, 3MG, 6MG, 9MG |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 204707 | AB (A-rated, therapeutically equivalent) | September 23, 2019 | 1.5MG, 3MG, 6MG, 9MG |
| CSPC OUYI PHARMACEUTICAL CO LTD | 212807 | AB (A-rated, therapeutically equivalent) | October 29, 2020 | 1.5MG, 3MG, 6MG, 9MG |
| ASCENT PHARMACEUTICALS INC | 216174 | AB (A-rated, therapeutically equivalent) | August 23, 2023 | 1.5MG, 3MG, 6MG, 9MG |
| AJANTA PHARMA LTD | 218514 | AB (A-rated, therapeutically equivalent) | June 26, 2024 | 1.5MG, 3MG, 6MG, 9MG |
| ALEMBIC PHARMACEUTICALS LTD | 218330 | AB (A-rated, therapeutically equivalent) | September 26, 2024 | 1.5MG, 3MG, 6MG, 9MG |
| ZYDUS PHARMACEUTICALS USA INC | 217445 | AB (A-rated, therapeutically equivalent) | October 8, 2024 | 1.5MG, 3MG, 6MG, 9MG |
| DR REDDYS LABORATORIES LTD | 205559 | AB (A-rated, therapeutically equivalent) | February 19, 2025 | 3MG, 6MG, 9MG |
| PHARMAZONE | 218755 | AB (A-rated, therapeutically equivalent) | September 4, 2025 | 1.5MG, 3MG, 6MG, 9MG |
| PHARMAZONE | 205402 | AB (A-rated, therapeutically equivalent) | May 7, 2026 | 1.5MG, 3MG, 6MG, 9MG |
Invega NDC codes
Questions
Is there a generic for Invega?
Yes. The generic name for Invega is paliperidone. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Invega products the Orange Book lists.
What is the generic name for Invega?
The active ingredient in Invega is paliperidone, per the FDA Orange Book.
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.