INVEGA TRINZA Drug Patent Profile

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-two 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 6^th, 2021.

Summary for INVEGA TRINZA

International Patents:	52
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Patent Applications:	133
Drug Prices:	Drug price information for INVEGA TRINZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INVEGA TRINZA
What excipients (inactive ingredients) are in INVEGA TRINZA?	INVEGA TRINZA excipients list
DailyMed Link:	INVEGA TRINZA at DailyMed

See drug prices for INVEGA TRINZA

Pharmacology for INVEGA TRINZA

Drug Class

Atypical Antipsychotic

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	10,143,693
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-004	May 18, 2015		RX	Yes	Yes	10,143,693
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-002	May 18, 2015		RX	Yes	Yes	10,143,693

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	207946-003	May 18, 2015	6,077,843*PED
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-001	May 18, 2015	6,077,843*PED
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-004	May 18, 2015	6,077,843*PED

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

Brazil

Canada

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hong Kong

Hungary

Israel

Japan

Lithuania

Moldova, Republic of

Morocco

New Zealand

Poland

Portugal

Serbia

Slovenia

South Korea

Spain

Taiwan

Ukraine

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
European Patent Office	4025188	SCHÉMAS POSOLOGIQUES ASSOCIÉS À DES FORMULATIONS INJECTABLES DE PALIPÉRIDONE À LIBÉRATION PROLONGÉE (DOSING REGIMENS ASSOCIATED WITH EXTENDED RELEASE PALIPERIDONE INJECTABLE FORMULATIONS)
World Intellectual Property Organization (WIPO)	2022112367
Eurasian Patent Organization	201792209	СХЕМА ВВЕДЕНИЯ ПРОПУЩЕННЫХ ДОЗ ИНЪЕКЦИОННЫХ СЛОЖНЫХ ЭФИРОВ ПАЛИПЕРИДОНА ДЛИТЕЛЬНОГО ДЕЙСТВИЯ

Supplementary Protection Certificates for INVEGA TRINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0904081	91842	Luxembourg		91842, EXPIRES: 20220512
0904081	416	Finland
0904081	PA2011008	Lithuania		PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304

INVEGA TRINZA Market Analysis and Financial Projection Experimental

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.