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Last Updated: March 29, 2024

INVEGA HAFYERA Drug Patent Profile


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Which patents cover Invega Hafyera, and what generic alternatives are available?

Invega Hafyera is a drug marketed by Janssen Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-one patent family members in thirteen countries.

The generic ingredient in INVEGA HAFYERA is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.

DrugPatentWatch® Generic Entry Outlook for Invega Hafyera

There are two tentative approvals for the generic drug (paliperidone palmitate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for INVEGA HAFYERA
Drug patent expirations by year for INVEGA HAFYERA
Drug Prices for INVEGA HAFYERA

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Pharmacology for INVEGA HAFYERA
Anatomical Therapeutic Chemical (ATC) Classes for INVEGA HAFYERA

US Patents and Regulatory Information for INVEGA HAFYERA

INVEGA HAFYERA is protected by three US patents and one FDA Regulatory Exclusivity.

Patents protecting INVEGA HAFYERA

Dosing regimens associated with extended release paliperidone injectable formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REINITIATION OF SCHIZOPHRENIA TREATMENT WHEREIN MORE THAN 6 MONTHS 3 WEEKS BUT LESS THAN 8 MONTHS HAVE ELAPSED SINCE THE LAST DOSE

Dosing regimens associated with extended release paliperidone injectable formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA BY ADMINISTERING A DOSE UP TO TWO WEEKS BEFORE OR THREE WEEKS AFTER THE SCHEDULED SIX-MONTH DOSE


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA BY ADMINISTRATION OF A SIX-MONTH PALIPERIDONE PALMITATE INJECTABLE SUSPENSION FILLED SYRINGE THAT HAS BEEN SHIPPED AND STORED IN A HORIZONAL POSITION

FDA Regulatory Exclusivity protecting INVEGA HAFYERA

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Exclusivity Expiration: ⤷  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
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
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
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 207946-005 Aug 30, 2021 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

International Patents for INVEGA HAFYERA

See the table below for patents covering INVEGA HAFYERA around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 3280416 SCHÉMA DE TRAITEMENT EN CAS DE DOSES OUBLIÉES POUR DES ESTERS DE PALIPÉRIDONE INJECTABLES À ACTION PROLONGÉE (DOSING REGIMEN FOR MISSED DOSES FOR LONG-ACTING INJECTABLE PALIPERIDONE ESTERS) ⤷  Try a Trial
Lithuania 3280416 ⤷  Try a Trial
Spain 2802299 ⤷  Try a Trial
Mexico 9804816 SUSPENSIONES ACUOSAS DE ESTERES DE ACIDO GRASO DE 9-HIDROXIRRISPERIDONA. (AQUEOUS SUSPENSIONS OF 9-HYDROXYRISPERIDONE FATTY ACID ESTERS.) ⤷  Try a Trial
Lithuania 4025187 ⤷  Try a Trial
Ukraine 61898 PHARMACEUTICAL COMPOSITION BASED ON 9-HYDROXYRISPERIDONE ESTERS, METHOD FOR ITS PRODUCTION AND METHOD FOR TREATMENT ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INVEGA HAFYERA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0904081 C00904081/01 Switzerland ⤷  Try a Trial PRODUCT NAME: PALIPERIDON PALMITATESTER; REGISTRATION NO/DATE: SWISSMEDIC 60466 20101215
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
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 11C0035 France ⤷  Try a Trial PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304
0904081 CA 2011 00020 Denmark ⤷  Try a Trial
0904081 2011/021 Ireland ⤷  Try a Trial 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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