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ERZOFRI

NDA

PALIPERIDONE PALMITATE | N216352 | LUYE INNOMIND PHARMA (SHIJIAZHUANG) CO LTD

6 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

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Today

11666573

Sep. 24, 2039

12128049

Oct. 26, 2038

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara, P.C. on behalf of Luye Innomi... FDA-2025-P-3542 · 3 docket documents The law firm Hyman, Phelps & McNamara, P.C., on behalf of Luye Innomind Pharma Shijiazhuang Co., Ltd., petitioned the FDA under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act to assign a therapeutic equivalence evaluation code of "AB" to five strengths of ERZOFRI (paliperidone palmita	Other	2025-09-04	Open	Luye Innomind Pharma Shijiazhuang Co., Ltd.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

40 trials from ClinicalTrials.gov, 36 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Safety and Pharmacokinetic Study of Paliperidone Palmitate in Patients With Schizophrenia NCT01150448	Phase 1	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	212	2007-09 → 2009-06
A Safety and Tolerability Study of Paliperidone Palmitate Injected in the Shoulder or the Buttock Muscle in Patients With Schizophrenia NCT00119756	Phase 3	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	253	2005-06 → 2006-11
A Pharmacokinetic and Safety Study of Paliperidone Palmitate (JNS010) in Participants With Schizophrenia NCT01606254	Phase 2	Completed	Janssen Pharmaceutical K.K.	56	2007-01 → 2008-04
A Study of Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics NCT01685931	Phase 4	Completed	Xian-Janssen Pharmaceutical Ltd.	617	2012-11 → 2014-12
A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia NCT00210548	Phase 3	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	366	2005-04 → 2006-06
A Comparison of Long-acting Injectable Medications for Schizophrenia NCT01136772	Phase 4	Completed	New York State Psychiatric Institute	311	2011-03 → 2016-07
A Concierge Model of CAE Plus LAI in Individuals With Schizophrenia at Risk for Treatment Non-adherence and Homelessness NCT02085447	N/A	Completed	University Hospitals Cleveland Medical Center	30	2014-05 → 2016-12
A Study of Transition to the Paliperidone Palmitate 3-Month Formulation In Participants With Schizophrenia Previously Stabilized on the Paliperidone Palmitate 1-Month Formulation NCT02713282	Phase 3	Completed	Janssen-Cilag Ltd.	306	2016-04-28 → 2018-03-26
A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder NCT01193153	Phase 3	Completed	Janssen Scientific Affairs, LLC	667	2010-09 → 2013-10
A Study of Paliperidone Palmitate in Japanese Patients With Schizophrenia NCT01258920	Phase 3	Completed	Janssen Pharmaceutical K.K.	201	2010-10 → 2012-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (6 FSS)

Lowest Price

$370.49

Highest Price

$4163.75

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
72526-0105-11ERZOFRI 39MG/KIT INJ,SUSP,SA	$370.49	FSS	Luye Pharma USA Ltd	09/30/2030
72526-0106-11ERZOFRI 78MG/KIT INJ,SUSP,SA	$791.43	FSS	Luye Pharma USA Ltd	09/30/2030
72526-0109-11ERZOFRI 234MG/KIT INJ,SUSP,SA	$2701.12	FSS	Luye Pharma USA Ltd	09/30/2030
72526-0107-11ERZOFRI 117MG/KIT INJ,SUSP,SA	$1383.70	FSS	Luye Pharma USA Ltd	09/30/2030
72526-0108-11ERZOFRI 156MG/KIT INJ,SUSP,SA	$1853.58	FSS	Luye Pharma USA Ltd	09/30/2030
72526-0110-11ERZOFRI 351MG/KIT INJ,SUSP,SA	$4163.75	FSS	Luye Pharma USA Ltd	09/30/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain11 active DMFs

10 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDPALIPERIDONE PALMITATE

DMF 246982011

NEULAND LABORATORIES LTDPALIPERIDONE PALMITATE

DMF 261952012

JUBILANT BIOSYS LTDPALIPERIDONE PALMITATE

DMF 272572013

MSN LABORATORIES PRIVATE LTDPALIPERIDONE PALMITATE [ROUTE CODE - PM"]

DMF 277872013

MATRIX PHARMACORP PRIVATE LTDPALIPERIDONE PALMITATE

DMF 301022015

MATRIX PHARMACORP PRIVATE LTDPALIPERIDONE PALMITATE (STERILE)

DMF 305972016

PIRAMAL PHARMA LTDPALIPERIDONE PALMITATE

DMF 325992018

INTERQUIM SAPALIPERIDONE PALMITATE

DMF 328522018

QILU PHARMACEUTICAL CO LTDPALIPERIDONE PALMITATE (STERILE)

DMF 364972021

APITORIA PHARMA PRIVATE LTDPALIPERIDONE PALMITATE

DMF 387442023

SUN PHARMACEUTICAL INDUSTRIES LTDPALIPERIDONE PALMITATE

DMF 388922024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 6, 2025	SUPPL -1	View Letter (PDF)
Jul 29, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 39MG/0.25ML (39MG/0.25ML)

RLD

2 patents0 exclusivities▴