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 four branded drugs marketed by Janssen Pharms and Teva Pharms Usa, and is included in three NDAs. There are five 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 thirty-three patent family members in thirty-two 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:	133
US Patents:	5
Tradenames:	4
Applicants:	2
NDAs:	3
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	58
Patent Applications:	298
Formulation / Manufacturing:	see details
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
Alliance for Clinical Trials in Oncology	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	117MG/0.75ML	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
⤷ Sign Up	⤷ Sign Up	78MG/0.5ML	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 HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-005	Aug 30, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	PALIPERIDONE PALMITATE	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	211149-003	Jul 6, 2021		DISCN	No	No	⤷ 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
>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	022264-005	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
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
Serbia	61765	REŽIM DOZIRANJA POVEZAN SA DUGODELUJUĆIM INJEKTABILNIM ESTRIMA PALIPERIDONA (DOSING REGIMEN ASSOCIATED WITH LONG ACTING INJECTABLE PALIPERIDONE ESTERS)	⤷ Sign Up
Japan	5825786		⤷ Sign Up
Eurasian Patent Organization	201792209	СХЕМА ВВЕДЕНИЯ ПРОПУЩЕННЫХ ДОЗ ИНЪЕКЦИОННЫХ СЛОЖНЫХ ЭФИРОВ ПАЛИПЕРИДОНА ДЛИТЕЛЬНОГО ДЕЙСТВИЯ	⤷ 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
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	11C0035	France	⤷ Sign Up	PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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