Paliperidone - Generic Drug Details

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, Cspc Ouyi, Inventia, Lupin Ltd, Rk Pharma, Sun Pharm, and Teva Pharms Usa, and is included in eleven NDAs. There are four 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. Thirteen suppliers are listed for this compound.

Summary for paliperidone

US Patents:	4
Tradenames:	6
Applicants:	9
NDAs:	11
Drug Master File Entries:	38
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	182
Patent Applications:	5,410
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
Janssen-Cilag International NV	Phase 4
Corcept Therapeutics	Phase 2
Newron Pharmaceuticals SPA	Phase 2

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
Rk Pharma	PALIPERIDONE	paliperidone	TABLET, EXTENDED RELEASE;ORAL	203802-003	Sep 24, 2015	AB	RX	No	No
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-005	Jul 31, 2009		RX	Yes	No
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-004	Dec 19, 2006		DISCN	Yes	No
Sun Pharm	PALIPERIDONE	paliperidone	TABLET, EXTENDED RELEASE;ORAL	205618-002	Apr 6, 2018	AB	RX	No	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	021999-004	Dec 19, 2006
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-002	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