PALIPERIDONE PALMITATE - Generic Drug Details

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What are the generic sources for paliperidone palmitate and what is the scope of patent protection?

Paliperidone palmitate is the generic ingredient in five branded drugs marketed by Luye Innomind Pharma, Janssen Pharms, and Teva Pharms Usa, and is included in four NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Paliperidone palmitate has one hundred and forty-three patent family members in thirty-three countries.

There are twelve drug master file entries for paliperidone palmitate. Two suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for PALIPERIDONE PALMITATE

International Patents:	143
US Patents:	6
Tradenames:	5
Applicants:	3
NDAs:	4
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	58
Patent Applications:	298
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PALIPERIDONE PALMITATE
What excipients (inactive ingredients) are in PALIPERIDONE PALMITATE?	PALIPERIDONE PALMITATE excipients list
DailyMed Link:	PALIPERIDONE PALMITATE at DailyMed

Recent Clinical Trials for PALIPERIDONE PALMITATE

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
Evolution Research Group	Phase 1

See all PALIPERIDONE PALMITATE clinical trials

Generic filers with tentative approvals for PALIPERIDONE PALMITATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up		SUSPENSION;EXTENDED RELEASE
⤷ Sign Up	⤷ Sign Up	234MG/1.5ML	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
⤷ Sign Up	⤷ Sign Up	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 PALMITATE

Drug Class	Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for PALIPERIDONE PALMITATE

Antipsychotic Agents
Dopamine D2 Receptor Antagonists
Serotonin 5-HT2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for PALIPERIDONE PALMITATE

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for PALIPERIDONE PALMITATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INVEGA TRINZA	Extended-release Injectable Suspension	paliperidone palmitate	273 mg/0.875 mL and 410 mg/1.315 mL	207946	1	2021-07-14
INVEGA TRINZA	Extended-release Injectable Suspension	paliperidone palmitate	819 mg/2.625 mL	207946	1	2021-04-30
INVEGA TRINZA	Extended-release Injectable Suspension	paliperidone palmitate	546 mg/1.75 mL	207946	1	2020-06-24
INVEGA SUSTENNA	Extended-release Injectable Suspension	paliperidone palmitate	39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL and 234 mg/1.5 mL	022264	1	2017-11-21

US Patents and Regulatory Information for PALIPERIDONE PALMITATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-002	May 18, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-005	Jul 26, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-006	Aug 30, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	PALIPERIDONE PALMITATE	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	211149-001	Jul 6, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-002	Jul 26, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 PALMITATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-004	Jul 31, 2009	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-005	Jul 31, 2009	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-005	Jul 31, 2009	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-004	Jul 31, 2009	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-003	Jul 31, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for PALIPERIDONE PALMITATE

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Country	Patent Number	Title	Estimated Expiration
South Korea	20170018489	장기 작용성 주사가능 팔리페리돈 에스테르와 관련된 투여 요법 (DOSING REGIMEN ASSOCIATED WITH LONG ACTING INJECTABLE PALIPERIDONE ESTERS)	⤷ Sign Up
Canada	3088401	PROGRAMME DE DOSAGE DE DOSES OUBLIEES DESTINE AUX ESTERS DE PALIPERIDONE INJECTABLES A ACTION PROLONGEE (DOSING REGIMEN FOR MISSED DOSES FOR LONG-ACTING INJECTABLE PALIPERIDONE ESTERS)	⤷ Sign Up
Lithuania	4025188		⤷ Sign Up
South Korea	102318070		⤷ Sign Up
China	101932327	Dosing regimen associated with long acting injectable paliperidone esters	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PALIPERIDONE PALMITATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0368388	SPC/GB07/065	United Kingdom	⤷ Sign Up	PRODUCT NAME: PALIPERIDONE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/395/001 20070625; UK EU/1/07/395/002 20070625; UK EU/1/07/395/003 20070625; UK EU/1/07/395/004 20070625; UK EU/1/07/395/005 20070625; UK EU/1/07/395/006 20070625; UK EU/1/07/395/007 20070625; UK EU/1/07/395/008 20070625; UK EU/1/07/395/009 20070625; UK EU/1/07/395/010 20070625; UK EU/1/07/395/011 20070625; UK EU/1/07/395/012 20070625; UK EU/1/07/395/013 20070625; UK EU/1/07/395/014 20070625; UK EU/1/07/395/015 20070625; UK EU/1/07/395/016 20070625; UK EU/1/07/395/017 20070625; UK EU/1/07/395/018 20070625; UK EU/1/07/395/019 20070625; UK EU/1/07/395/020 20070625; UK EU/1/07/395/021
0904081	11C0035	France	⤷ Sign Up	PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304
0904081	SPC/GB11/044	United Kingdom	⤷ Sign Up	PRODUCT NAME: PALIPERIDONE PALMITATE; REGISTERED: UK EU/1/11/672/001 20110304; UK EU/1/11/672/002 20110304; UK EU/1/11/672/003 20110304; UK EU/1/11/672/004 20110304; UK EU/1/11/672/005 20110304; UK EU/1/11/672/006 20110304
0368388	07C0044	France	⤷ Sign Up	PRODUCT NAME: PALIPERIDONE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/395/01 DU 20070626; REGISTRATION NO/DATE AT EEC: EU/1/07/395/01 DU 20070625
0904081	2011/021	Ireland	⤷ Sign Up	PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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