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Last Updated: May 28, 2022

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 thirty-two patent family members in twenty-four 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 three 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.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-004 May 18, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-002 May 18, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-003 May 18, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 207946-004 May 18, 2015 See Plans and Pricing See Plans and Pricing
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-002 May 18, 2015 See Plans and Pricing See Plans and Pricing
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-001 May 18, 2015 See Plans and Pricing See Plans and Pricing
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-003 May 18, 2015 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Patent: 20239611
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2017021383
Estimated Expiration: See Plans and Pricing

Canada

Patent: 25908
Estimated Expiration: See Plans and Pricing

Patent: 88401
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0201027
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 80416
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 7185
Estimated Expiration: See Plans and Pricing

Patent: 1792209
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 80416
Estimated Expiration: See Plans and Pricing

Patent: 44326
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 49047
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 49485
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4669
Estimated Expiration: See Plans and Pricing

Japan

Patent: 28221
Estimated Expiration: See Plans and Pricing

Patent: 18510894
Estimated Expiration: See Plans and Pricing

Patent: 20090498
Estimated Expiration: See Plans and Pricing

Patent: 21130680
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 80416
Estimated Expiration: See Plans and Pricing

Moldova, Republic of

Patent: 80416
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 917
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 5952
Estimated Expiration: See Plans and Pricing

Poland

Patent: 80416
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 80416
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 510
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 80416
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 170134583
Estimated Expiration: See Plans and Pricing

Spain

Patent: 02299
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 94825
Estimated Expiration: See Plans and Pricing

Patent: 1642863
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 8732
Estimated Expiration: See Plans and Pricing

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
Poland 327995 See Plans and Pricing
Hong Kong 1249047 用於長效可注射的帕利酮酯的遺漏劑量的投藥療程 (DOSING REGIMEN FOR MISSED DOSES FOR LONG-ACTING INJECTABLE PALIPERIDONE ESTERS) See Plans and Pricing
Cyprus 2270 Aqueous suspensions of 9-hydroxyrisperidone fatty acid esters See Plans and Pricing
New Zealand 330369 aqueous medicaments containing 9-hydroxy-risperidone fatty acid ester See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INVEGA TRINZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0904081 1190023-0 Sweden See Plans and Pricing PRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 20110304
0904081 CA 2011 00020 Denmark See Plans and Pricing
0904081 SPC/GB11/044 United Kingdom See Plans and Pricing 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 See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
Boehringer Ingelheim
Express Scripts
AstraZeneca
Merck

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