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Last Updated: March 1, 2024

INVEGA TRINZA Drug Patent Profile


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When do Invega Trinza patents expire, and what generic alternatives are available?

Invega Trinza is a drug marketed by Janssen Pharms and is included in one NDA. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has forty patent family members in twenty-five countries.

The generic ingredient in INVEGA TRINZA 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 Trinza

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (paliperidone palmitate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Paragraph IV (Patent) Challenges for INVEGA TRINZA
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

US Patents and Regulatory Information for INVEGA TRINZA

INVEGA TRINZA is protected by two US patents.

Patents protecting INVEGA TRINZA

Dosing regimen for missed doses for long-acting injectable paliperidone esters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO

Dosing regimen for missed doses for long-acting injectable paliperidone esters
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO

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 TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-001 May 18, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-004 May 18, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-002 May 18, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-003 May 18, 2015 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 INVEGA TRINZA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-001 May 18, 2015 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-002 May 18, 2015 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-003 May 18, 2015 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-004 May 18, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for INVEGA TRINZA

When does loss-of-exclusivity occur for INVEGA TRINZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 16244801
Estimated Expiration: ⤷  Try a Trial

Patent: 20239611
Estimated Expiration: ⤷  Try a Trial

Patent: 22221405
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2017021383
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 25908
Estimated Expiration: ⤷  Try a Trial

Patent: 88401
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0201027
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 23203
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 80416
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 7185
Estimated Expiration: ⤷  Try a Trial

Patent: 1792209
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 80416
Estimated Expiration: ⤷  Try a Trial

Patent: 44326
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 49047
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 49485
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 4669
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 28221
Estimated Expiration: ⤷  Try a Trial

Patent: 28503
Estimated Expiration: ⤷  Try a Trial

Patent: 22277
Estimated Expiration: ⤷  Try a Trial

Patent: 18510894
Estimated Expiration: ⤷  Try a Trial

Patent: 20090498
Estimated Expiration: ⤷  Try a Trial

Patent: 21130680
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 80416
Estimated Expiration: ⤷  Try a Trial

Patent: 44326
Estimated Expiration: ⤷  Try a Trial

Moldova, Republic of

Patent: 80416
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 917
Estimated Expiration: ⤷  Try a Trial

Patent: 511
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 5952
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 80416
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 80416
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 510
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 80416
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2606678
Estimated Expiration: ⤷  Try a Trial

Patent: 170134583
Estimated Expiration: ⤷  Try a Trial

Patent: 230162162
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 02299
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 94825
Estimated Expiration: ⤷  Try a Trial

Patent: 1642863
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 8732
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INVEGA TRINZA around the world.

Country Patent Number Title Estimated Expiration
Japan 2021130680 長時間作用型注射可能パリペリドンエステルの抜かした投与量のための投与レジメン (DOSING REGIMEN FOR MISSED DOSES FOR LONG-ACTING INJECTABLE PALIPERIDONE ESTERS) ⤷  Try a Trial
South Korea 20170134583 장기간 작용형 주사용 팔리페리돈 에스테르에 대한 누락된 용량에 대한 투여 계획 ⤷  Try a Trial
Czech Republic 9801401 ⤷  Try a Trial
Poland 3280416 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INVEGA TRINZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0904081 91842 Luxembourg ⤷  Try a Trial 91842, EXPIRES: 20220512
0904081 PA2011008,C0904081 Lithuania ⤷  Try a Trial PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.