Pharsight

1. List of Invega Hafyera drug patents

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

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 ad...

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

INVEGA HAFYERA family patents

United States

Australia

Japan

Morocco

Canada

European Union

Denmark

Hong Kong

Slovenia

Lithuania

Hungary

Moldova, Republic of

Croatia

Brazil

Portugal

Spain

Korea, Republic of

Poland

Taiwan, Province of China

Ukraine

New Zealand

2. List of Invega Sustenna drug patents

Application	Filing Date	Opposition Party	Legal Status
EP08863534A	2021-12-31	Zentiva k.s.	Granted and Under Opposition
EP08863534A	2021-12-31	EGIS Gyógyszergyár Zártkörüen Müködö Részvénytársaság	Granted and Under Opposition
EP08863534A	2021-12-30	Hoffmann Eitle SLU	Granted and Under Opposition
EP08863534A	2021-12-29	Gill Jennings & Every LLP	Granted and Under Opposition
EP08863534A	2021-12-29	Farmaprojects S.A.U.	Granted and Under Opposition
EP08863534A	2021-12-28	Laboratorios Lesvi, S.L.	Granted and Under Opposition
EP08863534A	2021-12-27	Sun Pharmaceutical Industries Europe B.V.	Granted and Under Opposition
EP08863534A	2021-12-27	Tolmar International Limited	Granted and Under Opposition
EP08863534A	2021-12-23	df-mp Dörries Frank-Molnia & Pohlman Patentanwälte Rechtsanwälte ParG mbB	Granted and Under Opposition
EP08863534A	2021-12-23	BIOGARAN	Granted and Under Opposition
EP08863534A	2021-12-22	EVER Valinject GmbH	Granted and Under Opposition
EP08863534A	2021-12-22	Hoffmann Eitle	Granted and Under Opposition
EP08863534A	2021-12-22	Accord Healthcare Ltd	Granted and Under Opposition
EP08863534A	2021-12-20	Sanovel Ilaç Sanayi Ve Ticaret Anonim Sirketi	Granted and Under Opposition
EP08863534A	2021-12-20	Maiwald Patent- und Rechtsanwaltsgesellschaft mbH	Granted and Under Opposition
EP08863534A	2021-12-20	Abbott Products Operations AG	Granted and Under Opposition
EP08863534A	2021-12-17	Stada-Arzneimittel Aktiengesellschaft	Granted and Under Opposition
EP08863534A	2021-12-10	Instone, Terry/Appleyard Lees IP LLP/Read, Howard	Granted and Under Opposition
EP08863534A	2021-12-03	Advanz Pharma Services (UK) Ltd.	Granted and Under Opposition
EP08863534A	2021-03-31	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition

Patent	Proceeding Filing Date	Status	Respondent	Petitioner
US9439906	February, 2020	Terminated-Denied	Janssen Pharmaceutica NV	Mylan Laboratories Ltd.

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9439906	JANSSEN PHARMS	Dosing regimen associated with long acting injectable paliperidone esters	Jan, 2031 (7 years from now)

Market Authorisation Date: 31 July, 2009

Treatment: Treatment of schizophrenia; Treatment of schizoaffective disorder as a monotherapy and as an adjunct to mood stabilizers or antidepressants; Dosing regimen for the treatment of schizoaffective disorde...

Dosage: SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL and 234 mg/1.5 mL	21 Nov, 2017	1	06 Jul, 2021	26 Jan, 2031	Deferred

Strength	Dosage	Availability
39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription
78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription
117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription
156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription
234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	Prescription