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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

US Patents:	2
Tradenames:	4
Applicants:	7
NDAs:	9
Drug Master File Entries:	38
Suppliers / Packagers:	11
Bulk Api Vendors:	123
Clinical Trials:	173
Patent Applications:	534
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for paliperidone
What excipients (inactive ingredients) are in paliperidone?	paliperidone excipients list
DailyMed Link:	paliperidone at DailyMed

See drug prices for paliperidone

Recent Clinical Trials for paliperidone

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

Sponsor	Phase
Corcept Therapeutics	Phase 2
Newron Pharmaceuticals SPA	Phase 2
Alliance for Clinical Trials in Oncology	Phase 1

See all paliperidone clinical trials

Pharmacology for paliperidone

Drug Class

Atypical Antipsychotic

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
Sun Pharm	PALIPERIDONE	paliperidone	TABLET, EXTENDED RELEASE;ORAL	205618-003	Apr 6, 2018	AB	RX	No	No
Cspc Ouyi	PALIPERIDONE	paliperidone	TABLET, EXTENDED RELEASE;ORAL	212807-004	Oct 29, 2020	AB	RX	No	No
Cspc Ouyi	PALIPERIDONE	paliperidone	TABLET, EXTENDED RELEASE;ORAL	212807-003	Oct 29, 2020	AB	RX	No	No
Cspc Ouyi	PALIPERIDONE	paliperidone	TABLET, EXTENDED RELEASE;ORAL	212807-002	Oct 29, 2020	AB	RX	No	No
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-002	May 18, 2015		RX	Yes	No

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
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-003	Dec 19, 2006
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-001	Dec 19, 2006
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-002	Dec 19, 2006
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-004	Dec 19, 2006