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Last Updated: February 8, 2025

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 fifty-four patent family members in twenty-six countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Invega Trinza

A generic version of INVEGA TRINZA was approved as paliperidone palmitate by TEVA PHARMS USA on July 6th, 2021.

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Drug patent expirations by year for INVEGA TRINZA
Drug Prices for INVEGA TRINZA

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Pharmacology for INVEGA TRINZA
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.

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 Yes ⤷  Free Trial ⤷  Free Trial ⤷  Free Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-004 May 18, 2015 RX Yes Yes ⤷  Free Trial ⤷  Free Trial ⤷  Free Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-002 May 18, 2015 RX Yes Yes ⤷  Free Trial ⤷  Free Trial ⤷  Free Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-003 May 18, 2015 RX Yes Yes ⤷  Free Trial ⤷  Free Trial ⤷  Free 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 ⤷  Free Trial ⤷  Free Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-004 May 18, 2015 ⤷  Free Trial ⤷  Free Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-003 May 18, 2015 ⤷  Free Trial ⤷  Free Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-002 May 18, 2015 ⤷  Free Trial ⤷  Free 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: ⤷  Free Trial

Patent: 20239611
Estimated Expiration: ⤷  Free Trial

Patent: 22221405
Estimated Expiration: ⤷  Free Trial

Patent: 24227790
Estimated Expiration: ⤷  Free Trial

Brazil

Patent: 2017021383
Estimated Expiration: ⤷  Free Trial

Canada

Patent: 25908
Estimated Expiration: ⤷  Free Trial

Patent: 88401
Estimated Expiration: ⤷  Free Trial

Croatia

Patent: 0201027
Estimated Expiration: ⤷  Free Trial

Patent: 0240022
Estimated Expiration: ⤷  Free Trial

Cyprus

Patent: 23203
Estimated Expiration: ⤷  Free Trial

Denmark

Patent: 80416
Estimated Expiration: ⤷  Free Trial

Patent: 44326
Estimated Expiration: ⤷  Free Trial

Eurasian Patent Organization

Patent: 7185
Estimated Expiration: ⤷  Free Trial

Patent: 1792209
Estimated Expiration: ⤷  Free Trial

European Patent Office

Patent: 80416
Estimated Expiration: ⤷  Free Trial

Patent: 44326
Estimated Expiration: ⤷  Free Trial

Patent: 49323
Estimated Expiration: ⤷  Free Trial

Finland

Patent: 44326
Estimated Expiration: ⤷  Free Trial

Hong Kong

Patent: 49047
Estimated Expiration: ⤷  Free Trial

Hungary

Patent: 49485
Estimated Expiration: ⤷  Free Trial

Patent: 65435
Estimated Expiration: ⤷  Free Trial

Israel

Patent: 4669
Estimated Expiration: ⤷  Free Trial

Patent: 9340
Estimated Expiration: ⤷  Free Trial

Japan

Patent: 28221
Estimated Expiration: ⤷  Free Trial

Patent: 28503
Estimated Expiration: ⤷  Free Trial

Patent: 22277
Estimated Expiration: ⤷  Free Trial

Patent: 18510894
Estimated Expiration: ⤷  Free Trial

Patent: 20090498
Estimated Expiration: ⤷  Free Trial

Patent: 21130680
Estimated Expiration: ⤷  Free Trial

Lithuania

Patent: 80416
Estimated Expiration: ⤷  Free Trial

Patent: 44326
Estimated Expiration: ⤷  Free Trial

Moldova, Republic of

Patent: 80416
Estimated Expiration: ⤷  Free Trial

Patent: 44326
Estimated Expiration: ⤷  Free Trial

Morocco

Patent: 917
Patent: Schéma de traitement en cas de doses oubliées pour des esters de palipéridone injectables à action prolongée
Estimated Expiration: ⤷  Free Trial

Patent: 511
Patent: SCHÉMA DE TRAITEMENT EN CAS DE DOSES OUBLIÉES POUR DES ESTERS DE PALIPÉRIDONE INJECTABLES À ACTION PROLONGÉE
Estimated Expiration: ⤷  Free Trial

New Zealand

Patent: 5952
Patent: Dosing regimen for missed doses for long-acting injectable paliperidone esters
Estimated Expiration: ⤷  Free Trial

Patent: 8246
Patent: Dosing regimen for missed doses for long-acting injectable paliperidone esters
Estimated Expiration: ⤷  Free Trial

Poland

Patent: 80416
Estimated Expiration: ⤷  Free Trial

Patent: 44326
Estimated Expiration: ⤷  Free Trial

Portugal

Patent: 80416
Estimated Expiration: ⤷  Free Trial

Patent: 44326
Estimated Expiration: ⤷  Free Trial

Serbia

Patent: 510
Patent: DOZNI REŽIM ZA PROPUŠTENE DOZE INJEKTIBILNIH ESTARA PALIPERIDONA SA PRODUŽENIM DELOVANJEM (DOSING REGIMEN FOR MISSED DOSES FOR LONG-ACTING INJECTABLE PALIPERIDONE ESTERS)
Estimated Expiration: ⤷  Free Trial

Patent: 024
Patent: DOZNI REŽIM ZA PROPUŠTENE DOZE INJEKTIBILNIH ESTARA PALIPERIDONA SA PRODUŽENIM DELOVANJEM (DOSING REGIMEN FOR MISSED DOSES FOR LONG-ACTING INJECTABLE PALIPERIDONE ESTERS)
Estimated Expiration: ⤷  Free Trial

Slovenia

Patent: 80416
Estimated Expiration: ⤷  Free Trial

Patent: 44326
Estimated Expiration: ⤷  Free Trial

South Korea

Patent: 2606678
Estimated Expiration: ⤷  Free Trial

Patent: 170134583
Estimated Expiration: ⤷  Free Trial

Patent: 230162162
Estimated Expiration: ⤷  Free Trial

Spain

Patent: 02299
Estimated Expiration: ⤷  Free Trial

Patent: 67585
Estimated Expiration: ⤷  Free Trial

Taiwan

Patent: 94825
Estimated Expiration: ⤷  Free Trial

Patent: 1642863
Patent: Dosing regimen for missed doses for long-acting injectable Paliperidone esters
Estimated Expiration: ⤷  Free Trial

Ukraine

Patent: 8732
Patent: СХЕМА ВВЕДЕННЯ ПРОПУЩЕНИХ ДОЗ ЕСТЕРІВ ПАЛІПЕРИДОНУ ТРИВАЛОЇ ДІЇ ДЛЯ ІН'ЄКЦІЙНОГО ЗАСТОСУВАННЯ (DOSING REGIMEN FOR MISSED DOSES FOR LONG-ACTING INJECTABLE PALIPERIDONE ESTERS)
Estimated Expiration: ⤷  Free 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
Portugal 4025187 ⤷  Free Trial
San Marino T202400077 ⤷  Free Trial
Spain 2973583 ⤷  Free Trial
Denmark 3280416 ⤷  Free Trial
Indonesia 16927 ⤷  Free 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 416 Finland ⤷  Free Trial
0904081 1190023-0 Sweden ⤷  Free Trial PRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 20110304
0904081 CA 2011 00020 Denmark ⤷  Free Trial
0368388 SPC/GB07/065 United Kingdom ⤷  Free Trial PRODUCT NAME: PALIPERIDONE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/395/001 20070625; UK EU/1/07/395/002 20070625; UK EU/1/07/395/003 20070625; UK EU/1/07/395/004 20070625; UK EU/1/07/395/005 20070625; UK EU/1/07/395/006 20070625; UK EU/1/07/395/007 20070625; UK EU/1/07/395/008 20070625; UK EU/1/07/395/009 20070625; UK EU/1/07/395/010 20070625; UK EU/1/07/395/011 20070625; UK EU/1/07/395/012 20070625; UK EU/1/07/395/013 20070625; UK EU/1/07/395/014 20070625; UK EU/1/07/395/015 20070625; UK EU/1/07/395/016 20070625; UK EU/1/07/395/017 20070625; UK EU/1/07/395/018 20070625; UK EU/1/07/395/019 20070625; UK EU/1/07/395/020 20070625; UK EU/1/07/395/021
0904081 PA2011008,C0904081 Lithuania ⤷  Free Trial PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for INVEGA TRINZA

Introduction

INVEGA TRINZA, a long-acting injectable antipsychotic medication, has been a significant player in the treatment of schizophrenia and bipolar disorder. Developed by Janssen Pharmaceutica, a subsidiary of Johnson & Johnson, this drug has seen substantial growth and impact in the pharmaceutical market.

FDA Approval and Market Entry

In 2015, the FDA approved INVEGA TRINZA, marking a significant milestone for the treatment of schizophrenia. This approval was based on a study that showed nearly all schizophrenia patients did not relapse while using INVEGA TRINZA, which is administered four times a year[4].

Clinical Significance

INVEGA TRINZA is notable for its long-acting formulation, which reduces the frequency of injections compared to its predecessor, INVEGA SUSTENNA. Patients must first undergo at least four months of once-a-month dosing with INVEGA SUSTENNA before transitioning to INVEGA TRINZA. This transition helps in maintaining therapeutic levels of the medication and ensures patient compliance[4].

Market Impact

The approval of INVEGA TRINZA has been a growth driver in the schizophrenia market. According to market research, the introduction of this longer-acting formula was expected to contribute significantly to the growth of the schizophrenia market, which was predicted to swell to $6.4 billion by 2017 from $5.9 billion in 2013[4].

Financial Performance

Sales Growth

INVEGA TRINZA, along with other long-acting INVEGA products, has contributed substantially to Johnson & Johnson's pharmaceutical segment. In the third quarter of 2021, Johnson & Johnson reported that pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 13.8%, with INVEGA SUSTENNA and INVEGA TRINZA being major contributors to this growth[1].

Royalty Revenues

Alkermes plc, which receives royalties from the sales of INVEGA SUSTENNA, INVEGA TRINZA, and other long-acting INVEGA products, reported significant royalty revenues. For instance, in the second quarter of 2023, Alkermes recorded $321.2 million in royalty revenues from these products, including back royalties and associated interest[2].

Impact of Licensing Agreements

However, there was a partial termination of the license agreement related to the sales of long-acting INVEGA products in the United States, effective February 2, 2022. This led to a decrease in royalty revenues for Alkermes in the first quarter of 2023 compared to the same period in the prior year[5].

Regional Sales Performance

The sales performance of INVEGA TRINZA and other INVEGA products has been robust across different regions. Johnson & Johnson reported that in the third quarter of 2021, international sales of pharmaceuticals, which include INVEGA products, increased by 13.8%, while U.S. sales grew by 7.9%[1].

Competitive Landscape

The schizophrenia market is competitive, but INVEGA TRINZA's unique long-acting formulation has helped it stand out. Decision Resources predicted that INVEGA TRINZA would be one of the main growth drivers in this market, highlighting its competitive advantage[4].

Patient and Healthcare Provider Perspective

Compliance and Efficacy

The long-acting nature of INVEGA TRINZA enhances patient compliance, as it reduces the frequency of injections. This is particularly beneficial for patients with schizophrenia, who often face challenges with medication adherence.

Cost Considerations

The cost of INVEGA TRINZA can vary significantly based on factors such as dosage, geographical location, and health insurance coverage. On average, the retail cost of INVEGA SUSTENNA, which is closely related to INVEGA TRINZA, is around $4,089 per year, though this can vary widely[3].

Future Outlook

Despite the partial termination of the license agreement, the INVEGA franchise, including INVEGA TRINZA, is expected to continue contributing significantly to Johnson & Johnson's pharmaceutical sales. The unique benefits of INVEGA TRINZA, such as its long-acting formulation and proven efficacy, position it well for continued market success.

Key Takeaways

  • FDA Approval: INVEGA TRINZA was approved by the FDA in 2015 for the treatment of schizophrenia.
  • Market Impact: It has been a significant growth driver in the schizophrenia market.
  • Financial Performance: The drug has contributed to substantial sales and royalty revenues for Johnson & Johnson and Alkermes.
  • Regional Sales: Strong sales performance across U.S. and international markets.
  • Competitive Advantage: Unique long-acting formulation enhances patient compliance and efficacy.
  • Cost Considerations: Varies based on dosage, location, and insurance coverage.

FAQs

What is INVEGA TRINZA used for?

INVEGA TRINZA is used for the treatment of schizophrenia and is administered four times a year.

How does INVEGA TRINZA differ from INVEGA SUSTENNA?

INVEGA TRINZA is a longer-acting formulation compared to INVEGA SUSTENNA, requiring injections only four times a year.

What was the impact of FDA approval on the market?

The FDA approval of INVEGA TRINZA was expected to drive growth in the schizophrenia market, which was predicted to reach $6.4 billion by 2017.

How have royalty revenues been affected by licensing agreements?

The partial termination of the license agreement led to a decrease in royalty revenues for Alkermes in 2023 compared to the prior year.

What factors influence the cost of INVEGA TRINZA?

The cost of INVEGA TRINZA varies based on dosage, geographical location, and health insurance coverage.

Sources

  1. Johnson & Johnson. FOR IMMEDIATE RELEASE: Total sales growth of 10.7% to $23.3 Billion.
  2. Alkermes plc. Alkermes plc Reports Second Quarter 2023 Financial Results.
  3. The Rx Advocates. Invega Sustenna Coupon & Assistance Programs – Cost $70/month.
  4. FiercePharma. J&J sees Invega franchise boost with FDA nod for longer-acting Trinza version.
  5. Alkermes plc. Alkermes plc Reports First Quarter 2023 Financial Results.

More… ↓

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