Paliperidone - Generic Drug Details

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

Paliperidone is the generic ingredient in seven branded drugs marketed by Janssen Pharms, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms, Ascent Pharms Inc, Cspc Ouyi, Inventia, Lupin Ltd, Rk Pharma, Sun Pharm, Zydus Pharms, Luye Innomind Pharma, and Teva Pharms Usa, and is included in sixteen NDAs. There are six 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. Eighteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for paliperidone

US Patents:	6
Tradenames:	7
Applicants:	14
NDAs:	16
Drug Master File Entries:	38
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	184
Patent Applications:	3,538
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
Instituto de Salud Carlos III	Phase 4
Consorcio Centro de Investigación Biomédica en Red (CIBER)	Phase 4
First Affiliated Hospital Xi'an Jiaotong University	N/A

See all paliperidone clinical trials

Generic filers with tentative approvals for PALIPERIDONE

Applicant	Application No.	Strength	Dosage Form
			SUSPENSION;EXTENDED RELEASE
		234MG/1.5ML	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
		156MG/ML	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

Anatomical Therapeutic Chemical (ATC) Classes for paliperidone

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

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
Lupin Ltd	PALIPERIDONE	paliperidone	TABLET, EXTENDED RELEASE;ORAL	208643-004	Jun 29, 2022	BX	RX	No	No
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-001	Jul 31, 2009	AB	RX	Yes	No
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-005	Jul 26, 2024		RX	Yes	Yes

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	021999-003	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

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