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Last Updated: March 1, 2021

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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 four branded drugs marketed by Janssen Pharms, Actavis Labs Fl Inc, Amneal Pharms, Cspc Ouyi, Inventia, Rk Pharma, and Sun Pharm, and is included in nine NDAs. There are two 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. Eleven suppliers are listed for this compound.

Summary for paliperidone
Drug Prices for paliperidone

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Recent Clinical Trials for paliperidone

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SponsorPhase
Corcept TherapeuticsPhase 2
Newron Pharmaceuticals SPAPhase 2
Alliance for Clinical Trials in OncologyPhase 1

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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
Inventia PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 204452-001 Jun 12, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 205618-003 Apr 6, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Cspc Ouyi PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 212807-004 Oct 29, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Cspc Ouyi PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 212807-003 Oct 29, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Cspc Ouyi PALIPERIDONE paliperidone TABLET, EXTENDED RELEASE;ORAL 212807-002 Oct 29, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-002 May 18, 2015 RX Yes No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-003 Dec 19, 2006   Start Trial   Start Trial
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-001 Dec 19, 2006   Start Trial   Start Trial
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-002 Dec 19, 2006   Start Trial   Start Trial
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-004 Dec 19, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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