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Last Updated: November 21, 2024

PALIPERIDONE Drug Patent Profile


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When do Paliperidone patents expire, and when can generic versions of Paliperidone launch?

Paliperidone is a drug marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Ascent Pharms Inc, Cspc Ouyi, Inventia, Lupin Ltd, Rk Pharma, Sun Pharm, Zydus Pharms, and Teva Pharms Usa. and is included in twelve NDAs.

The generic ingredient in PALIPERIDONE is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Paliperidone

A generic version of PALIPERIDONE was approved as paliperidone palmitate by TEVA PHARMS USA on July 6th, 2021.

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Summary for PALIPERIDONE
Drug patent expirations by year for PALIPERIDONE
Drug Prices for PALIPERIDONE

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Recent Clinical Trials for PALIPERIDONE

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SponsorPhase
Consorcio Centro de Investigación Biomédica en Red (CIBER)Phase 4
Instituto de Salud Carlos IIIPhase 4
First Affiliated Hospital Xi'an Jiaotong UniversityN/A

See all PALIPERIDONE clinical trials

Pharmacology for PALIPERIDONE
Anatomical Therapeutic Chemical (ATC) Classes 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
Zydus Pharms PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 217445-001 Oct 8, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lupin Ltd PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 208643-004 Jun 29, 2022 BX RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa PALIPERIDONE PALMITATE paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 211149-005 Jul 6, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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