PALIPERIDONE - Generic Drug Details

What are the generic drug sources for paliperidone and what is the scope of freedom to operate?

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. Seventeen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for PALIPERIDONE

US Patents:	5
Tradenames:	6
Applicants:	10
NDAs:	12
Drug Master File Entries:	38
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	183
Patent Applications:	4,104
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
First Affiliated Hospital Xi'an Jiaotong University	N/A
Janssen-Cilag International NV	Phase 4
Corcept Therapeutics	Phase 2

See all PALIPERIDONE clinical trials

Generic filers with tentative approvals for PALIPERIDONE

Applicant	Application No.	Strength	Dosage Form
			SUSPENSION;EXTENDED RELEASE
		78MG/0.5ML	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
		39MG/0.25ML	SUSPENSION, 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

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
Rk Pharma	PALIPERIDONE	paliperidone	TABLET, EXTENDED RELEASE;ORAL	203802-002	Sep 24, 2015	AB	RX	No	No
Lupin Ltd	PALIPERIDONE	paliperidone	TABLET, EXTENDED RELEASE;ORAL	208643-001	Jun 29, 2022	AB	RX	No	No
Amneal Pharms	PALIPERIDONE	paliperidone	TABLET, EXTENDED RELEASE;ORAL	204707-004	Sep 23, 2019	AB	RX	No	No
Actavis Labs Fl Inc	PALIPERIDONE	paliperidone	TABLET, EXTENDED RELEASE;ORAL	202645-002	Aug 3, 2015	AB	RX	No	No
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-006	Aug 30, 2021		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	021999-002	Dec 19, 2006
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-003	Dec 19, 2006
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-006	Aug 26, 2008
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-004	Dec 19, 2006
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-001	Dec 19, 2006

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