FDA Orange Book · active-ingredient family
Paliperidone
Paliperidone is approved as 1 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:INVEGA · NDA 021999
1
Brand (NDA)
15
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| INVEGARLD×5 | JANSSEN PHARMS | NDA 021999 | — | Aug 26, 2008 |
Generic (ANDA) products (15)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PALIPERIDONE×4 | I3 PHARMS | ANDA 205402 | AB | May 07, 2026 | |
| PALIPERIDONE×3 | APOTEX | ANDA 203279 | — | Jan 26, 2026 | |
| PALIPERIDONE×4 | ESKAYEF | ANDA 218755 | AB | Sep 04, 2025 | |
| PALIPERIDONE×3 | DR REDDYS | ANDA 205559 | AB | Feb 19, 2025 | |
| PALIPERIDONE×4 | ZYDUS PHARMS | ANDA 217445 | AB | Oct 08, 2024 | |
| PALIPERIDONE×4 | ALEMBIC | ANDA 218330 | AB | Sep 26, 2024 | |
| PALIPERIDONE×4 | AJANTA PHARMA LTD | ANDA 218514 | AB | Jun 26, 2024 | |
| PALIPERIDONE×4 | ASCENT PHARMS INC | ANDA 216174 | AB | Aug 23, 2023 | |
| PALIPERIDONE×4 | LUPIN | ANDA 208643 | — | Jun 29, 2022 | |
| PALIPERIDONE×4 | CSPC OUYI | ANDA 212807 | AB | Oct 29, 2020 | |
| PALIPERIDONE×4 | AMNEAL PHARMS | ANDA 204707 | AB | Sep 23, 2019 | |
| PALIPERIDONE×4 | INVENTIA | ANDA 204452 | AB | Jun 12, 2019 | |
| PALIPERIDONE×4 | SUN PHARM | ANDA 205618 | AB | Apr 06, 2018 | |
| PALIPERIDONE×4 | RK PHARMA | ANDA 203802 | — | Sep 24, 2015 | |
| PALIPERIDONE×4 | ACTAVIS LABS FL INC | ANDA 202645 | — | Aug 03, 2015 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Paliperidone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
