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Last Updated: February 29, 2024

Paliperidone - Generic Drug Details


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What are the generic sources for paliperidone and what is the scope of patent protection?

Paliperidone is the generic ingredient in six branded drugs marketed by Janssen Pharms, Actavis Labs Fl Inc, Amneal Pharms, Ascent Pharms Inc, Cspc Ouyi, Inventia, Lupin Ltd, Rk Pharma, Sun Pharm, and Teva Pharms Usa, and is included in twelve NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are thirty-eight drug master file entries for paliperidone. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for paliperidone

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Recent Clinical Trials for paliperidone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
Janssen-Cilag International NVPhase 4
Corcept TherapeuticsPhase 2

See all paliperidone clinical trials

Generic filers with tentative approvals for PALIPERIDONE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial39MG/0.25MLSUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
⤷  Try a Trial⤷  Try a Trial234MG/1.5MLSUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
⤷  Try a Trial⤷  Try a Trial156MG/MLSUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for paliperidone

US Patents and Regulatory Information for paliperidone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cspc Ouyi PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 212807-001 Oct 29, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 208643-003 Jun 29, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rk Pharma PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 203802-003 Sep 24, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ascent Pharms Inc PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 216174-004 Aug 23, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-004 Jul 31, 2009 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ascent Pharms Inc PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 216174-003 Aug 23, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for paliperidone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-006 Aug 26, 2008 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-003 Dec 19, 2006 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-001 Dec 19, 2006 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-002 Dec 19, 2006 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-004 Dec 19, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for paliperidone

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen-Cilag International N.V.   Byannli (previously Paliperidone Janssen-Cilag International) paliperidone EMEA/H/C/005486
Byannli (previously Paliperidone Janssen-Cilag International) a 6 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly or 3 monthly paliperidone palmitate injectable products (see section 5.1).
Authorised no no no 2020-06-18
Janssen-Cilag International NV Trevicta (previously Paliperidone Janssen) paliperidone EMEA/H/C/004066
Trevicta, a 3 monthly injection, is indicated for the maintenance treatment of schizophrenia in adult patients who are clinically stable on 1 monthly paliperidone palmitate injectable product.
Authorised no no no 2014-12-05
Janssen-Cilag International N.V. Xeplion paliperidone EMEA/H/C/002105
Xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.
Authorised no no no 2011-03-04
Janssen-Cilag International NV Invega paliperidone EMEA/H/C/000746
Invega is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older.Invega is indicated for the treatment of schizoaffective disorder in adults.
Authorised no no no 2007-06-24
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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