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Last Updated: April 22, 2024

Paliperidone palmitate - Generic Drug Details


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

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 seven patent family members in thirty-one countries.

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

Recent Clinical Trials for paliperidone palmitate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
Janssen-Cilag International NVPhase 4
Evolution Research GroupPhase 1

See all paliperidone palmitate clinical trials

Generic filers with tentative approvals for PALIPERIDONE PALMITATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialSUSPENSION;EXTENDED RELEASE
⤷  Try a Trial⤷  Try a Trial234MG/1.5MLSUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
⤷  Try a Trial⤷  Try a Trial156MG/MLSUSPENSION, 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
Medical Subject Heading (MeSH) Categories for paliperidone palmitate
Anatomical Therapeutic Chemical (ATC) Classes for paliperidone palmitate
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

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 SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-001 Jul 31, 2009 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa PALIPERIDONE PALMITATE paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 211149-004 Jul 6, 2021 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA HAFYERA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-005 Aug 30, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA HAFYERA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-006 Aug 30, 2021 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa PALIPERIDONE PALMITATE paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 211149-002 Jul 6, 2021 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-002 Jul 31, 2009 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-001 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-005 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-001 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA SUSTENNA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 022264-001 Jul 31, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for paliperidone palmitate

Country Patent Number Title Estimated Expiration
Australia 2021388842 METHODS FOR ENSURING RESUSPENSION OF PALIPERIDONE PALMITATE FORMULATIONS ⤷  Try a Trial
Slovenia 3280416 ⤷  Try a Trial
Japan 6728221 ⤷  Try a Trial
Ecuador SP10010289 RÉGIMEN DE DOSIFICACIÓN ASOCIADO CON ÉSTERES DE PALIPERIDONA INYECTABLES DE ACCIÓN PROLONGADA ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2022111858 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2016164218 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for paliperidone palmitate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0368388 07C0044 France ⤷  Try a Trial 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 ⤷  Try a Trial PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
0368388 SPC/GB07/065 United Kingdom ⤷  Try a Trial 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 SPC/GB11/044 United Kingdom ⤷  Try a Trial 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
0904081 11C0035 France ⤷  Try a Trial 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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