Pharsight

Invega Hafyera is owned by Janssen Pharms.

Invega Hafyera contains Paliperidone Palmitate.

Invega Hafyera has a total of 3 drug patents out of which 0 drug patents have expired.

Invega Hafyera was authorised for market use on 18 May, 2015.

Invega Hafyera is available in suspension, extended release;intramuscular dosage forms.

Invega Hafyera can be used as reinitiation of schizophrenia treatment wherein more than 6 months 3 weeks but less than 8 months have elapsed since the last dose, reinitiation of schizophrenia treatment following a missed dose more than 9 months ago; reinitiation of schizophrenia treatment following a missed dose 4-9 months ago, treatment of schizophrenia by administering a dose up to two weeks before or three weeks after the scheduled six-month dose.

The generics of Invega Hafyera are possible to be released after 07 May, 2041.

Application	Filing Date	Opposition Party	Legal Status
EP16777058A	2021-01-22	df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte ParG mbB	Granted and Under Opposition
EP16777058A	2021-01-22	Hoffman Eitle Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB	Granted and Under Opposition
EP16777058A	2021-01-22	STADA Arzneimittel AG	Granted and Under Opposition
EP16777058A	2021-01-21	Hexal AG	Granted and Under Opposition
EP16777058A	2021-01-21	Teva Pharmaceutical Industries Ltd.	Granted and Under Opposition
EP16777058A	2021-01-21	Accord Healthcare Ltd	Granted and Under Opposition
EP16777058A	2021-01-19	Hamm&Wittkopp Patentanwälte PartmbB	Granted and Under Opposition
EP16777058A	2020-12-01	Instone, Terry/Read, Howard Graham/Appleyard Lees IP LLP	Granted and Under Opposition

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10143693	JANSSEN PHARMS	Dosing regimen for missed doses for long-acting injectable paliperidone esters	Apr, 2036 (13 years from now)
US11324751	JANSSEN PHARMS	Dosing regimens associated with extended release paliperidone injectable formulations	May, 2041 (18 years from now)
US11304951	JANSSEN PHARMS	Dosing regimens associated with extended release paliperidone injectable formulations	May, 2041 (18 years from now)

Exclusivity	Exclusivity Expiration
New Strength (NS)	Aug 30, 2024

Drugs and Companies using PALIPERIDONE PALMITATE ingredient

Market Authorisation Date: 18 May, 2015

Treatment: Reinitiation of schizophrenia treatment following a missed dose more than 9 months ago; Reinitiation of schizophrenia treatment following a missed dose 4-9 months ago; Treatment of schizophrenia by administering a dose up to two weeks before or three weeks after the scheduled six-month dose; Reinitiation of schizophrenia treatment wherein more than 6 months 3 weeks but less than 8 months have elapsed since the last dose

Dosage: SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

Strength	Submission Date	ANDA(s) Filed	Last patent expiry
546 mg/1.75 mL	24 Jun, 2020	1	05 Apr, 2036
819 mg/2.625 mL	30 Apr, 2021	1	05 Apr, 2036
273 mg/0.875 mL and 410 mg/1.315 mL	14 Jul, 2021	1	05 Apr, 2036

Strength	Dosage	Availability
1.092GM/3.5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription
1.560GM/5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription
273MG/0.875ML (273MG/0.875ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription
410MG/1.315ML (311.79MG/ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription
546MG/1.75ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription
819MG/2.625ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription